The mid-pregnancy intakes of total energy, macronutrients and vitamins were lower than the recommended intakes for pregnant Japanese women. Maternal total energy intake was positively associated with the offspring’s birth weight; there was a 10-g mean difference in the offspring’s birth weight of mothers in the lowest (3026 g) v. highest (3036 g) quartiles of energy intake. Carbohydrate intake was positively associated with the offspring’s birth length (mean difference of 0·7 cm) and inversely associated with the ponderal index (mean difference of 0·8 g/cm3). Offspring of mothers in the highest v. lowest quartiles of total dietary fibre intake were on average 9 g heavier and had 0·3 cm longer birth length and 0·2 cm longer head circumference. The highest in reference to lowest intake quartile of vitamin C was associated with 13 g and 0·7 cm mean differences in the offspring’s birth weight and length, respectively. Several other associations were evident for maternal intakes of vitamins and the offspring’s birth size. In conclusion, maternal dietary intakes of energy, dietary fibre, carbohydrate and vitamins during pregnancy were associated with the offspring’s birth size.Maternal diet during pregnancy can influence fetal growth; however, the available evidence is controversial. We aimed to assess whether maternal diet of Japanese women in mid-pregnancy can affect their offspring’s birth size via collection of questionnaire and medical record data. The studied sample was a large cohort of paired mothers and their singleton offspring ( Maternal diet during pregnancy can influence fetal growth directly and/or indirectly through affecting maternal body weight. Except for Japan, maternal obesity is rapidly increasing in the developed countries and is associated with increased offspring’s birth weight. In contrary, since 1970, a decreasing trend in the BMI of Japanese women was noticed, and meanwhile accompanied by almost a double-fold increase in the rate of low birth weight in the country since then. In order to keep the desired lean body shape, Japanese women usually adopt inappropriate diet and continue to do so even during pregnancy,9,10. Dietary intakes of macro- and micronutrients among Japanese women prior to and during pregnancy were lower than the Japanese dietary references.Optimising maternal dietary balance could be a novel appropriate approach for potential improvement of offspring’s body composition–13 and macronutrient intakes during pregnancy,12–14 were frequently reported to be not associated with the estimated fetal body weight or birth weight. Maternal carbohydrate intake, in the Singapore Growing up towards Healthy Outcomes (GUSTO) study, was positively associated with the offspring’s birth length and accordingly inversely associated with the ponderal index. Other studies, however, showed that the fetal growth and birth size were inversely associated with carbohydrate intake and positively associated with protein intake in early pregnancy,15,16. Intakes of total energy, protein and fat, in all trimesters of pregnancy, were positively associated with the newborn’s weight in an Indian study.Previous studies that showed the association between dietary macronutrient intakes during pregnancy and birth size were inconsistent in their conclusions. Energy content, while maternal intakes of n-3 long-chain PUFA, folic acid and vitamin D have shown potential effects on the offspring’s birth weight–20.On the other hand, dietary and supplemental vitamins are essential for the biological activity, and their status varies widely throughout pregnancy and across populations. For example, folic acid intake during pregnancy can efficiently prevent neural tube defects of the offspring, the available evidence has been driven from studies that included a limited number of women–4,11–20. In light of previous literature, it is obvious that the relation of maternal macronutrient and vitamin intakes during pregnancy and the offspring’s birth size is still unclear. Therefore, this study was conducted to investigate the prospective associations of maternal consumption of macronutrients and vitamins in early pregnancy and the offspring’s birth size in a large cohort of Japanese women.In addition to the scanty of studies that investigated maternal diet and the offspring’s birth size among Japanese,22. In brief, the Japan Environment and Children’s Study included women during early pregnancy who were attending local governmental offices that issue pregnancy and child follow-up handbooks and/or attending obstetric facilities where pregnancy follow-up was conducted. Eventually, 103 099 pregnancies from fifteen Japanese communities were registered and followed up between the years 2011 and 2014. The Japan Environment and Children’s Study protocol was in full accordance with the Helsinki declaration and was reviewed and approved by the Ministry of the Environment’s Institutional Review Board on Epidemiological Studies and by the Ethics Committees of all participating institutions. All subjects have given a written informed consent to participate.The Japan Environment and Children’s Study is a large birth cohort study that was funded by the Japan Ministry of the Environment. The detailed study protocol and methodology were described previously was distributed during the second/third trimester to determine the usual food consumption throughout the current pregnancy, and a total of 98 037 women completed this FFQ. The final sample in this analysis consisted of 78 793 women, after excluding women with multiple gestations, stillbirths, abortions and maternal chronic diseases that might require nutritional therapy and those with missing nutritional or covariates data . A standard portion size was specified for each item of the FFQ, and the response options for the intake frequency ranged from almost never to ≥7 times/d for foods and from almost never to ≥10 glasses/d for beverages. The intake frequencies were multiplied by the specified portion size, and accordingly, we estimated the daily intakes of all items in the FFQ. Nutrients’ contents of each food were driven from the Japanese food composition tables 5th revised revision, and the daily intakes of nutrients were calculated by summing the contents from all the food items after multiplying by the frequency of consumption.A FFQ. Instructions were given to repeat the measurements for unusual measurements’ values. The ponderal index was calculated from the recorded birth weight and birth length as follows: ponderal index = weight in g/(crown–heel length in cm)3.From the newborn medical records at birth, we obtained data about birth weight (g), birth length, head circumference and chest circumference (cm). All measurements were conducted by trained and experienced staffs according to the Japanese standardised manualMother and offspring’s characteristics were obtained from self-administered questionnaires that were distributed at first trimester, second/third trimesters, delivery and 1 month after delivery, and from health check-ups during pregnancy, medical records and obstetricians’ data. Medical records  transcriptions were performed by physicians, midwives/nurses and/or research coordinators. Therefore, a large bulk of information was obtained including maternal sociodemographic characteristics, lifestyle habits, in addition to medical, obstetrics and paediatric histories.,27. The proportion of women with intakes less than the estimated average requirement was given for each nutrient. The maternal and offspring’s characteristics were compared among binary stratified variables of nutrients  using the Wilcoxon signed-rank test for continuous variables and the χ2 test for categorical ones. Because the distributions of the nutritional variables under study were skewed, the Kruskal–Wallis test and ANCOVA of the generalised linear modelling procedure for the log-transformed intakes of nutrients were used. Accordingly, we compared the univariate and multivariable-adjusted mean differences in the offspring’s birth size indices  across the quartiles of maternal intakes of total energy, energy-adjusted (by density method) macronutrients  and vitamins . The geometric means of nutrients in the generalised linear modelling procedure were adjusted for maternal age (continuous), height (continuous), education , household income , prepregnancy BMI , net weight change during pregnancy , parity , smoking habit , ethanol drinking habit during pregnancy , mother’s thyroid disease (yes or no), use of folate supplement (yes or no), offspring’s sex (dichotomous) and gestational age at delivery (continuous). The median values of each nutrient intake in each quartile were used to calculate the Pfor trend across the increasing quartiles of maternal dietary intakes via the generalised linear modelling procedure. Moreover, linear regression analyses were conducted to estimate the changes in the offspring’s birth size parameters with 1-sd increment of maternal macronutrients intakes. Probability values for statistical tests were two-tailed, and P < 0·05 was regarded as statistically significant with at least 80 % statistical power for testing. The SAS statistical package  was used for the analyses.The analyses of the present study were based on the data set jecs-ag-20160424. Medians and interquartile ranges of the studied women’s intakes of macronutrients and vitamins during pregnancy were compared with the estimated average requirement for Japanese pregnant women in the second trimesterThe main characteristics of the studied 78 793 pregnant Japanese women are given in v. insufficient intake groups of all nutrients, except for energy and carbohydrate. The proportions of alcohol users were higher in the sufficient intake group when compared with the insufficient intake group of most nutrients, except for carbohydrate. The proportions of nulliparous women and women who gained <7·0 kg during the pregnancy were lower in the sufficient v. insufficient intake groups for all nutrients, except for carbohydrate and fat. The mean gestational age of the offspring was lower in the sufficient than that in the insufficient intake groups of dietary variables, except for carbohydrate, fat and vitamin C  were higher, while the proportions of smoking women were lower in the sufficient itamin C .v. lowest quartiles of total energy intake. Women in the highest v. those in the lowest quartiles of dietary fibre intake gave birth to on average 9 g heavier and 0·3 cm taller babies. Maternal carbohydrate intake was positively associated with the offspring’s birth length and inversely associated with the ponderal index; fat intake was also inversely associated with the ponderal index, whereas protein intake was not associated with birth size . As shown in 6, B12 and folate were associated with their babies’ birth length; vitamins A, E and D intakes were associated with head circumference; vitamins A, C and D intakes were associated with chest circumference, whereas intakes of vitamin K were inversely associated with the ponderal index of the offspring.There were significant increases in the offspring’s mean birth weight, birth length, head circumference and chest circumference and decreases in the mean ponderal index across the increasing quartiles of maternal dietary intakes of energy, total fibre and the most studied vitamins (online Supplementary Tables S1 and S2). After adjusting for maternal and offspring’s characteristics, there was 10 g increment in the birth weight of offspring born to mothers in the highest rth size . One-sd In this large cohort of Japanese women, maternal dietary intakes of total energy, macronutrients and vitamins were associated with the offspring’s birth size. Meanwhile, these intakes were lower than the dietary recommended intakes for pregnant Japanese women.,9,10. Japanese women keenness to keep a thin body together with their strict adherence to the nutritional guidelines for weight control during pregnancy could be possible explanations of the findings of the current research.Our findings that Japanese pregnant women tended to have dietary intakes lower than the RDI are matching results of previous studies–20,29–32. However, those studies that reported maternal dietary intakes during pregnancy to be associated with the offspring’s birth size justified their findings by two pathways: indirect effects through the changes in the maternal body weight,15,16,29 and direct effects of maternal dietary intakes on the fetal growth and body composition–3,11,12.Findings from the previous literature were a mix of discrepancies regarding the associations between maternal nutrition during pregnancy and the offspring’s birth size,11–14, and one study has reported an inverse association with neonatal abdominal obesity. However, the positive association between maternal total energy intake and the offspring’s birth weight in our study is matching those reported in a few previous studies,33. This could be justified by the fact that with the additional need for extra energy content during pregnancy for placental and fetal growths, the low mean energy intake of Japanese pregnant women (lower than RDI) could be under the threshold of energy intake that might be associated inversely with the offspring’s birth size.In contrary to our findings, many studies have shown no associations between the mother’s energy content intake and the newborn’s birth size. The majority of the previous studies showed no associations of both carbohydrate and fat intakes during pregnancy with birth weight,11,12,14 and head circumference of the newborn. However, positive associations were also documented in some other studies,17,29,30. In contrary, one Japanese study showed that dietary patterns during pregnancy rich in bread, soft drinks and confectioneries and low in vegetables and fish have inverse associations with the baby’s birth weight.High maternal intakes of carbohydrate were positively associated with the offspring’s birth length, and none of carbohydrate, fat or protein intakes was associated with the birth weight of the offspring in the multivariable-adjusted analysis of the current study. In a study of multi-ethnic Asian population, the addition of carbohydrate in non-energetic addition models and the substitution of carbohydrate for protein in energetic substitution models were positively associated with the newborn’s birth length, and there were no associations of carbohydrate, fat or protein intakes with the birth weight,17,29,33, inverse associations with birth weight and birth length, and no association,12–14 with birth weight of the offspring.The association between protein intake of mothers and the offspring’s birth size lost its significance in the multivariable-adjusted model. Some of the released investigations reported positive associations of the mother’s protein intake with birth weight. Higher intakes of insoluble dietary fibre by pregnant Chinese women were positively associated with their offspring’s birth weight. Our study is the first, up to our knowledge, to investigate and to show positive associations between maternal intakes of dietary fibre and the offspring’s birth weight, birth length, head circumference and inverse associations with the ponderal index.Optimal dietary fibre intake during pregnancy is important for both the mother’s health and fetal growth–19,31,36. Vitamin C intake in early pregnancy was the only nutrient to show a positive association with birth weight in prospective studies in south England and China. Folate dietary intakes, measured at several occasions during pregnancy, were positively associated with the birth weight in an Indian study, while folate supplementation during pregnancy was positively associated with birth weight but not birth length or head circumference, especially in women with high BMI in low-income countries. On the other hand, a German study showed that the mother’s intake of vitamins was not associated with their newborn’s birth weight. To the contrary, a study in New Zealand has shown that higher intakes of vitamin B during pregnancy were inversely associated with the birth size of winter born offspring and a Chinese study reported that folate intake during pregnancy was inversely associated with the offspring’s birth weight.The positive associations between maternal dietary intakes of most studied vitamins with the offspring’s birth size in our study are matching the findings from some previous reports. Maternal intakes of vitamin D and folic acid were positively associated with the birth weight,13,17. Moreover, the proportions of offspring with low birth weight, <2500 g across the quartiles of maternal total energy intake in our study, were 8·4 % in Q1, 7·6 % in Q2, 7·2 % in Q3 and 7·1 % in Q4; Pfor trend < 0·001. Other limitations of the current study include the possibility of multicollinearity of the maternal intakes of nutrients because of common dietary sources. Thus, the contribution of other unstudied maternal dietary factors towards the offspring’s birth size cannot be excluded. The observed associations depended mainly on early- to mid-pregnancy dietary intakes that were measured once, at the time of the second/third trimester questionnaire. Dietary intakes could have changed throughout pregnancy; however, some studies have not only shown that measuring the maternal diet in early pregnancy is important for various organs’ differentiation and development,12,18–20, but also indicated that dietary intakes are likely to be relatively constant throughout pregnancy,38. Moreover, the same FFQ was distributed to the same cohort of women in our study in the first trimester asking about the previous 1-year intakes and showed similar low dietary intakes than the Japanese dietary recommended intakes.The huge discrepancies in the results of the studies that composed the previous literature on the one hand, and between findings of our study and those from the previous studies on the other hand can be attributed to the large differences in the population culture, characteristics and dietary habits, sample sizes, adjustment for maternal and offspring characteristics and tools used for dietary assessment. Therefore, with the large sample size of our study, the use of a validated FFQ that covered almost all the common and uncommonly consumed foods and beverages, and the adjustment of maternal and offspring characteristics, we believe that the generalisability of our study findings to the Japanese population is plausible. Yet, with the unique low dietary intakes of pregnant Japanese women, even before pregnancy, the generalisability of the findings to other populations cannot be guaranteed. Meanwhile, despite the significant differences in the outcome variables across the nutrients’ categories, the absolute values of these differences are minimal and might lack clinical meaning in the neonatal field. However, such small significant changes in the birth size parameters were also reported in the previous studies6, B12 and folate intakes. Accordingly, the ponderal index, a proxy for the offspring’s overall adiposity, was inversely associated with maternal carbohydrates, total fibre and vitamin K intakes. Head circumference was positively associated with vitamins A, E and D intakes, while chest circumference was associated mainly with the mother’s intake of vitamins A, D and C. These findings could help postulate the pregnancy dietary guidelines to prevent unfavourable birth size of the Japanese women’s offspring.In summary, dietary intakes of energy, macronutrients and vitamins among Japanese pregnant women were associated with the offspring’s birth size. The offspring’s birth weight was related mainly to maternal intakes of total energy, dietary fibre and vitamins A, K, E, D, C and folate, whereas the birth length was related to maternal carbohydrates, total fibre, vitamins K, C, D, B


Infants with congenital diaphragmatic hernia (CDH) often experience hypoxemia with acidosis immediately after birth. The traditional approach in the delivery room is immediate cord clamping followed by intubation. Initiating resuscitation prior to umbilical cord clamping (UCC) may support this transition.To establish the safety and feasibility of intubation and ventilation prior to UCC for infants with CDH. To compare short-term outcomes between trial participants and matched controls treated with immediate cord clamping before intubation and ventilation.2 detection. The primary feasibility endpoint was successful intubation prior to UCC. Prespecified safety and physiologic outcomes were compared with historical controls matched for prognostic variables using standard bivariate tests.Single-arm, single site trial of infants with CDH and gestational age ≥ 36 weeks. Infants were placed on a trolley immediately after birth and underwent intubation and ventilation, with UCC performed after qualitative COOf 20 enrolled infants, all were placed on the trolley and 17 (85%) were intubated before UCC. The first hemoglobin and mean blood pressure at 1 hour of life were significantly higher in trial participants than controls. There were no significant differences between groups for subsequent blood pressure values, vasoactive medications, inhaled nitric oxide, or ECMO. Blood gas and oxygenation index values did not differ between groups at any point.Intubation and ventilation prior to UCC is safe and feasible among infants with CDH. The impact of this approach on clinically relevant outcomes deserves investigation in a randomized trial. Physiologic adaptation after birth is a critical transition for infants with congenital diaphragmatic hernia (CDH). In utero, the fetus has fluid-filled lungs, and gas exchange occurs at the placenta. Immediately after birth, the infant must aerate the lungs, which triggers a physiologic transition of reduced pulmonary vascular resistance, increased pulmonary blood flow, and gas exchange in the lung. ,2 InfantLimited data inform the delivery room management for infants with CDH. The stanPerforming intubation and establishing ventilation prior to UCC in the delivery room entails coordination of multiple team members and equipment. Previous investigators found that initiating non-invasive respiratory support prior to UCC was safe and feasible in other populations, –18 but fThe objectives of this pilot trial were to: 1) establish the safety and feasibility of intubation and ventilation prior to UCC for infants with CDH and 2) compare short-term outcomes between infants treated with intubation and ventilation prior to UCC and matched historical controls treated with immediate cord clamping before intubation and ventilation.Clinicaltrials.gov Identifier NCT03314233). Eligible infants had an antenatal diagnosis of CDH and were at least 36 weeks gestation at birth. Exclusion criteria were: other major anomalies, enrollment in an ongoing trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO), multiple gestation, palliative care planned or considered, placental abnormalities , and maternal magnesium sulfate therapy. Informed consent was obtained from mothers of potentially eligible infants in the prenatal clinic setting, and eligibility criteria were confirmed immediately before delivery. If all eligibility criteria were met, the mother/infant dyad was allocated to receive the study intervention.This was a single-arm, single site trial at the Children’s Hospital of Philadelphia . Suction tubing was connected to canisters in the labor room or obstetrical suite. Midway through the trial, this equipment was replaced by a portable T-piece resuscitator that included suction . Airway equipment and respiratory tubing were not sterile and were handled to avoid contact with the sterile operative field for cesarean deliveries.2O, FiO2 0.5). UCC was performed after consistent qualitative colorimetric CO2 detection, with guidelines for maternal uterotonic administration after UCC. After UCC, the neonatal team moved the trolley and respiratory equipment away from the mother, taped the endotracheal tube, covered the infant with warm towels, and transported the infant with ongoing ventilation to the resuscitation warmer bed. All remaining care was per clinical guidelines. The protocol stipulated for UCC to be performed prior to intubation for any of the following: the infant could not be placed on the trolley, intubation was not successful within 3 minutes from birth, cord avulsion or bleeding, or any obstetrical or neonatal provider concerns.Immediately after delivery, the obstetrical provider placed the infant on the trolley. The neonatologist intubated the infant, and ventilation was commenced using settings per hospital protocol . Feasibility outcomes and timing of procedural interventions were recorded by a dedicated staff member and abstracted from video recordings when available.2] and qualitative evaluation of interventricular septal position at the end of systole .Physiologic outcomes included first hemoglobin measurement, mean blood pressure values and blood gas parameters in the first 48 hours after birth, the first clinically obtained echocardiogram, and mortality in the first week after birth. Echocardiogram images were independently reviewed by an unblinded single assessor (MF) for signs of pulmonary hypertension. If present, the severity of pulmonary hypertension was graded based on the most severe assessment of the following criteria: direction of shunting at the ductus arteriosus , estimated systolic right ventricular pressures through continuous wave interrogation of the tricuspid regurgitant jet and calculation of a systolic right ventricle-to-right atrium pressure gradient by using the modified Bernoulli equation [pressure gradient = 4 × Jet velocityInterventions assessed included respiratory support and inhaled nitric oxide in the first 48 hours of life, and extracorporeal membrane oxygenation (ECMO) in the first week after birth. Historical controls were identified from an ongoing pulmonary hypoplasia program registry and matched with trial participants on the basis of gestational age, mode of delivery, side of CDH, liver position , and observed to expected lung-to-head ratio (O/E LHR) obtained by anterior-posterior method on prenatal ultrasound using the TOTAL trial calculator. All contWe planned a sample of 20 infants allocated to the intervention for this pilot trial to assess the feasibility of the study procedure. Using Stata 15.1 , outcomes were reported with descriptive statistics. Safety and physiological outcomes were compared between trial participants and historical controls using t-test for normally distributed variables and Wilcoxon rank sum test for nonparametric variables. Dichotomous variables were assessed with chi-squared test and Fisher’s exact test, as appropriate. A p-value <0.05 was considered statistically significant.This study was approved by the Children’s Hospital of Philadelphia Institutional Review Board (17-014125). To ensure the trial did not impose undue additional risk on trial participants, an independent Data Safety Monitoring Board reviewed safety outcomes of enrolled participants at three scheduled intervals.Between January-October 2018, 20 eligible infants were allocated to receive the intervention . Demogra2 detection was 14  seconds. In 3 cases the infant was not successfully intubated by 3 minutes after birth, and the umbilical cord was therefore clamped and cut prior to intubation. Two of these infants were born via vaginal delivery and one via cesarean delivery. Neonatal providers in those cases identified that infant positioning was the major impediment to procedural success, and all 3 of these infants were intubated after UCC once placed on the warmer bed.All 20 infants were placed on the trolley and 17 (85%) were successfully intubated prior to UCC : Study intervention performed following a cesarean delivery


Hydatid cyst is an infectious disease caused by « ECHINOCOCCUS GRANULOSIS », it can be asymptomatic or manifests depending on size, location, and relation with other organs, or by complication like rupture. This latter might occur spontaneously or post-traumatic, and it might manifest with an anaphylactic shock, a life-threatening situation.Anaphylactic shock is a rare cause of traumatic shock state.A 30 years old man with no medical history was admitted to the emergency room after a car accident, on his admission, his Glasgow coma scale was 10/15 with a blood pressure of 80/30 mmHg, he was intubated and stabilized hemodynamically. The full-body CT scan showed no abnormalities except on the thoracic level where it showed a well-limited rounded formation with regular contours containing hydro-aeric level related to ruptured hydatid cyst.After ruling out the diagnosis of hemorrhagic, hypovolemic shock, the diagnosis of anaphylactic shock due to a post-traumatic rupture of the hydatid cyst was maintained.Post-traumatic rupture of the hydatid cyst is a rare emergency that requires early diagnosis and management. Surgery remains the principal treatment of ruptured hydatid cyst.Anaphylactic shock is a life-threatening situation with various symptoms; epinephrine is the cornerstone for management of this type of shock. It is uIn this paper, we will represent a rare case of a 30 years old man victim of a car accident leading to a rupture of an unknown pulmonary hydatid cyst manifesting with an anaphylactic shock.2A previously healthy 30 years old man, with no medical history, was admitted to the emergency room after a car accident: rollover by his car.or limb fracture, the respiratory rate was 25 cycles/min, and pulse oximetry 75% on ambient air, 85% on high concentration mask with ronchis on the right side. The Glasgow Coma Scale GCS was 10/15  with contracted pupils, and no localization signs.The physical examination on his admission was as follows: hearts rate of 145 beats/minute, blood pressure of 80/30 mmHg, with no signs of external bleeding, medullar trauma At this moment a decision to put the patient on mechanical ventilation was taking with inspiratory fraction of oxygen at 100%, tidal volume og 6 mL/kg and pression end expiratory pressure at 3mBar, with pulse oximetry at 93%.prothrombin time 80%, fibrinogen 3.5 g/l, white blood cells 7500/mL, eosinphils 55%, normal renal function : creatinine 0.8 mg/dl, urea 0.30 g/L.The complete blood count showed the following: hemoglobin 12 g/dl, platelets 350000/mL, After hemodynamic stabilization by fluid restitution with 500 mL of saline serum, and introduction of norepinephrine 1 mg/h, the full-body computerized tomography CT scan was performed, and it showed no internal bleeding, pneumothorax or medullar trauma, and showed on the thoracic level where it showed a well limited rounded formation of regular contours containing a hydro-aeric level related to a ruptured hydatid cyst .Fig. 1CTAfter ruling out the possibility of a hemorrhagic, hypovolemic shock, the diagnosis of anaphylactic shock due to post-traumatic rupture of hydatid cyst was maintained, norepinephrine was switched with epinephrine with a dose of 2 mg/h, and we gave him 500 mg of hydrocortisone with improvement in the hemodynamic state.The patient was admitted to the operating room the next day for cyst removal by open thoracotomy .Fig. 2RuIn the postoperative period, Albendazole was started with a dose of 400 mg/day.The evolution was favorable; he was extubated in the immediate post-operative period and referred to the thoracic department.3Hydatid cyst is a zoonotic infectious disease caused by « ECHINOCOCCUS GRANULOSUS », it is transmitted to human, an intermediated host, by direct contact with dogs or sheeps .The lung is the second frequent localization of hydatid cyst after liver infection ,9.Because of the delay of the diagnosis, the hydatid cyst remains asymptomatic for years and grows to big sizes and the clinical signs depend generally on the location, size, and relation with adjacent organs ,10,11. IThe rupture of the hydatid cyst might occur spontaneously due to increased pressure or size of the cyst or post-traumatic, the latter is a rare event with high morbidity and lethality rates ,7.The clinical signs of ruptured pulmonary hydatid cyst might include coughing, chest pain, hemoptysis, hydatidemesis, and anaphylactic shock, a life-threatening situation .CT scan is the gold standard for hydatic cyst diagnostic with a sensitivity of 95%, the images of ruptured hydatic cyst show essentially hydro-aeric levels ,17.The diagnosis of ruptured hydatid cyst must be immediate because it requires appropriate surgical management .Cutaneous and mucosal signs are often the first signs to appear but they might be missing, especially during severe reactions with immediate state of shock [Anaphylactic shock might be revealed with cardiovascular signs (collapse…), respiratory signs , dermatologic signs , and neurological signs  . Cutaneoof shock . Epinephof shock .Surgery remains the principal treatment of ruptured hydatid cyst, the mean goal of surgery is to eliminate the cyst, minimize morbidity and reduce recurrences .The principal of surgery consists on complete excision with maximum preservation of lung tissue .Albendazole, with a dose of 10 mg/kg/day for 12 months should be started on the immediate post-operative period to avoid recurrences .4Post-traumatic rupture of pulmonary hydatid cyst is a rare life-threatening situation requiring an early diagnosis and proper management to avoid severe complications that might include death.CT scan is the gold standard to make the diagnosis of ruptured hydatid cyst and surgery remains the essential treatment.The work has been reported in line with the SCARE 2020 guideline .The authors state that they have no conflicts of interest for this report.This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.The ethical committee approval was not required given the article type (case report).Written informed consent was obtained from the patient for publication of this case report and accompanying images.AABDI Mohammed: study concept, Data collection; data analysis; writing review & editing.MALKI Khalil: Study conception, data analysis.MELLAGUI Yassine: contributor.BKIYAR Houssam: Supervision and data validation.HOUSNI Brahim: supervision and data validation.Not Applicable.AABDI Mohammed.MALKI Khalil.Not commissioned, externally peer-reviewed.The data used to support the findings of this study are available from the corresponding author upon request.Aabdi Mohammed: Writing - original draft, Conceptualization, Methodology, Software, Validation, Formal analysis, Visualization. Khalil Malki: Resources, Data curation, Software. Yassine Mellagui: Formal analysis, Visualization. Houssam Bkiyar: Writing - review & editing, Visualization. Brahim Housni: Project administration, Visualization, Writing - review & editing, Resources, Conceptualization, Methodology, Validation.


Background: Placental abnormalities are associated with inflammation and have been linked to brain injury in preterm infants. We studied the relationship between placental pathology and the temporal profiles of cytokine levels in extremely pre-term infants.Study Design: We prospectively enrolled 55 extremely preterm infants born between June 2017 and July 2018. Levels of 27 cytokines were measured in blood drawn from the umbilical artery at birth and from infants at 1–3 and 21–28 days of life. Placental pathology was grouped as normal (N), inflammation (I), vasculopathy (V), or combined vasculopathy and inflammation (V+I).Results: Complete data was available from 42 patients. Cord blood median levels of cytokines differed between groups with the highest levels observed in group V+I as compared to groups N, I and V for the following: Eotaxin (p = 0.038), G-CSF (p = 0.023), IFN-γ (p = 0.002), IL-1ra (p < 0.001), IL-4 (p = 0.005), IL-8 (p = 0.010), MCP-1 (p = 0.011), and TNFα (p = 0.002). Post-hoc analysis revealed sex differences between and within the placental pathology groups.Conclusion: Specific types of placental pathology may be associated with differential cytokine profiles in extremely pre-term infants. Sampling from cord blood may help assess the pathological status of the placenta and potentially infer outcome risks for the infant. AlthougThe placenta is a dynamic feto-maternal organ, and the role of the maternal-fetal unit (mother-placenta-fetus) is complex and interactive, so the effect of one compartment on outcomes may not be straight forward or linear. Clinical studies have repeatedly demonstrated an association between placental abnormalities and neurodevelopmental outcomes in term and pre-term infants –11.Intrauterine inflammation resulting from abnormal placental pathology, like chorioamnionitis, is associated with fetal inflammatory response characterized by high inflammatory cytokines. Cytokines, chemokines, and growth factors (hereafter referred to as cytokines) play important roles in inflammation and cell signaling. They also can influence the various stages of brain development –15. AnimThe presence of placental pathology other than chorioamnionitis with or without funisitis can trigger an inflammatory response in the fetus. There is therefore a pressing need to study the association between various types of placental pathology and cytokine profiles in pre-term infants. This may help improve our understanding of the link between different types of placental pathology and the increased risk of brain injury or neurodevelopmental deficits in the absence of histologic chorioamnionitis.The main objective of this study was to evaluate the relationship between placental pathology and the temporal profiles of cytokine levels in extremely pre-term infants. We hypothesized that cytokine profiles drawn from extremely pre-term infants would correlate with abnormalities seen on placental pathology and that the patterns of cytokines will reflect the different pathologies. A secondary objective was to describe the trends of cytokines' expression over time in these infants.Extremely preterm infants born between 23 weeks and 0 days to 28 weeks and 6 days GA, admitted to the Level III neonatal intensive care unit (NICU) at Foothills Medical Center, Calgary, Alberta, between June 2017 and July 2018, were prospectively enrolled. Infants with suspected or confirmed congenital and chromosomal abnormalities, congenital infections, and severe intrauterine growth restriction defined as less than the third percentile on the Fenton growth chart (2), sepsis (early and late-onset), patent ductus arteriosus (PDA), intraventricular hemorrhage (IVH), cystic periventricular leukomalacia, and retinopathy of prematurity.Relevant pregnancy, birth, and neonatal data were collected from the medical records including maternal age, gravidity, history of smoking, alcohol or illicit drug use during pregnancies, diabetes , hypertension (pregnancy-induced or chronic), assisted conception, multiple pregnancy, antenatal steroids, antepartum hemorrhage , preterm premature rupture of membranes (PPROM) >24 h, clinical chorioamnionitis  and modeBlood was collected from enrolled infants at three timepoints: timepoint 1 (T1) from the umbilical cord at birth, timepoint 2 (T2), from the infants between 24 and 72 h of birth, and timepoint 3 (T3), from the infants, between 21 and 28 days of birth. Arterial umbilical cord blood was collected in silicone-coated serum tubes, without additives, and initially stored at 4°C until consent was obtained. Once the infant was enrolled, its cord blood sample was centrifuged at 1,000 g, and the separated serum was aliquoted into cryovials and stored at −80°C until analysis. At T2 and T3, 0.4 ml of blood was collected in lithium heparin tubes, and samples were centrifuged at 3,700 g; the separated plasma was aliquoted in cryovials and stored at −80°C. All samples were stored in the Alberta Children's Hospital BioCORE facility until assayed. To minimize additional samplings from the infants, blood was collected concurrently with routine and clinically indicated blood sampling. Most of the samples, at T2 and T3, were taken from heel pokes (capillary), with only a few taken by venous route.Cytokine levels were assayed using the Bio-Rad Multiplex Immunoassay System, which uses microbead suspension array technology . Relative cytokine levels were generated using the commercially available and standardized plate Bio-Plex Pro™ Human Cytokine 27-plex Assay (#M500KCAF0Y). The targeted cytokines included: Interleukin (IL)−1 beta (IL-1β), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, interleukin-1 receptor antagonist (IL-1ra), Eotaxin, basic fibroblast growth factor (FGF-basic), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon-gamma (INF-γ), interferon-inducible protein-10 (Ip-10), monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory protein-1 alpha (MIP-1α), macrophage inflammatory protein-1 beta (MIP-1β), platelet-derived growth factor-BB (PDGF-BB), Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES), tumor necrosis factor-alpha (TNF-α), vascular endothelial growth factor (VEGF).Head ultrasound scans were performed as per standard clinical protocol and normal care of very preterm infants. The scans were assessed by a neuroradiologist who was unaware of the clinical course of the infants. IVH grading was in accordance with that described by Papile  and desiAfter receiving the placentas fresh from the labor and delivery ward, the pathologists assessed the membranes, measured the cord, and documented its insertion, length, diameter, and appearance. They also weighed and measured the disc, after removing the cord and membranes, and again documented the appearance of the disc with the fetal and maternal surface. For microscopy, the following sections were taken: two cross-sections of the cord, one membrane roll, and sections of the central placental disc, and in areas of any lesions identified. The sections for histology were fixed in 10% buffered formalin and processed overnight for histology and stained with Hematoxylin and Eosin. Placental slides were read and graded as per the Amsterdam consensus paper  by an exInflammatory findings in the placenta included maternal inflammatory response (MIR) and fetal inflammatory response (FIR), and both were further divided into three stages per Khong et al. . MIR staFinally, placental findings were grouped into (1) normal (N), (2) evidence of inflammation (I), (3) presence of vasculopathy (V), (4), and combined pathology of vasculopathy and inflammation (V+I).P-value < 0.05.Data were analyzed using SPSS version 25 . With the annual admission of 120–130 extremely preterm infants to our NICU, and the inability to do a power calculation for our study, we used a convenient sample and recruited as many participants as possible. Descriptive statistics were used to summarize neonatal and maternal demographic characteristics, and data were presented as medians and interquartile range (IQR). After testing for normality (SPSS), the Kruskal-Wallis H test was conducted to determine if there were differences in cytokine levels between the four groups of placental pathology. Subsequently, pairwise comparisons were performed using Dunn's procedure. A Friedman test was run to determine if there were differences in cytokine levels between the three timepoints of sampling. Bonferroni corrections for multiple comparisons were made, and statistical significance was set at p = 0.984), birth weight (p = 0.255), and SNAP II PE (p = 0.169).Of the 115 extremely preterm infants admitted to our NICU during the study period, 55 (48%) were enrolled in our study . Thirteep = 0.018). Two infants had severe IVH, one from group V and the other from group V+I. One infant had grade III IVH developed bilateral cystic periventricular leukomalacia and died after the withdrawal of care at 6 weeks of age. Another infant with severe BPD died after discharge from the NICU. None of the infants included in the final analysis had early-onset sepsis or pneumothorax.The median (IQR) GA was 26 (25–27) weeks, and the median (IQR) birth weight was 840  grams. There were no significant differences between the demographic  and clinp = 0.013), and diabetes was associated with abnormal placentas of all three categories. Antepartum hemorrhage was more common among the group with normal placentas (p = 0.009); this group also received less antenatal steroids (75% compared to 100%) than the other three groups (p = 0.03).In terms of maternal variables, hypertension was associated with placentas categorized as having vasculopathy or combined changes (Histologic findings of the 42 cases were as follows: 8/42 (19%) cases had no significant histologic findings, 12/42 (29%) had acute inflammation, 13/42 (31%) had vasculopathy findings, and 9/42 (21%) had combined inflammation and vasculopathy findings. MIR was seen in 21/42 (50%) of the placental pathology readings, and histologic chorioamnionitis was diagnosed in 15/21 (71%), while chorionitis or acute subchorionitis was seen in the remaining 6/21 (29%) cases. FIR was seen in 18/42 (43%) cases, and all were associated with MIR changes. None of the placentas had findings of chronic inflammation. Maternal vascular malperfusion was more common  than fetal vascular malperfusion .There were no differences in cytokine levels between cases of acute chorioamnionitis alone or acute chorioamnionitis with FIR at the three timepoints. Also, no significant differences were noted when comparing between the stages of MIR or FIR.Median levels of several cytokines differed across the four placental groups , and valSignificant differences in cytokine levels over the three sampling timepoints are shown in post-hoc analysis, at T1, males had significant differences in levels of Eotaxin, G-CSF, IFN-γ, IL-1ra, IL-4, IL-8, MCP-1, and TNF-α between the placental pathology groups with the highest levels noted in the V+I group. In females, however, there were no significant differences in cytokine levels  levels in extremely pre-term infants. Of the 27 cytokines measured, eight showed significant differences between the four groups of placental pathology, and this significance was mostly noted from samples drawn from umbilical cord blood soon after birth. Cytokine levels also varied between the three timepoints within groups and between infants within each placental pathology group over time. Males had significant differences in cytokine levels between placental pathology groups, while females had significantly higher levels of specific cytokines in the I group as compared to males in samples drawn from cord blood. In our study, we also compared cytokine concentrations between different placental pathology groups, where we differentiated between I and V groups and noted higher levels of these cytokines when there was evidence of both vasculopathy and inflammation (V+I) in the placentas. The higher levels of cytokines in the V+I group at T1 suggests an increased effect of placental inflammation when in the context of concomitant vasculopathy; a finding that was more pronounced in males, which makes delineation of other sex differences in biological measures an interesting area of investigation that we are exploring in ongoing research.The source of measured cytokines at T1 can be fetal, maternal, placental, or a combination. Concerning fetal sources of cytokines, studies examining whether cytokines cross the placenta have shown conflicting results. In 2004, Zaretsky et al. reported on the bidirectional crossing of IL-6 but not of IL-1β or TNF-α . HoweverMany of the cytokines in our study can either have a direct pleiotrophic effect on the central nervous system , 27 or hCytokine stability varies depending on the collection method and storage time before processing, and while cytokine concentrations were reported to be higher in serum compared to plasma , serum spost-hoc analysis is the sex-dependent differences in cytokine concentrations that suggest the differences between levels among placental groups at T1 may be partially driven by the male sex. In comparison analysis across placental groups in females showed that the concentrations of G-CSF, IFN-γ, IL-1ra, IL-8, MCP-1, and TNF-α were higher in group I and group (V+I) at T1 as compared to later timepoints, although this did not reach statistical significance, and maybe partially explained by the smaller sample size in each of the pathology groups. This finding may have particular clinical relevance as other studies have shown male sex to be associated with higher risk maternal complications, fetal distress during labor, and increased rates of placental abnormalities , University of Calgary. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin.HZ, KM, M-AB, and ME made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. M-AB and HZ reviewed the placental pathology slides. HZ and ME drafted the first manuscript. KM, LL, AK, and M-AB contributed to critical revision for important intellectual content and approved the publication's final version. All authors contributed to the article and approved the submitted version.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Although women in low- and middle-income countries are increasingly encouraged to give birth at facilities, healthcare-associated infection of both the mother and newborn remain common. An important cause of infection is poor hand hygiene. There is a need to understand how environmental, behavioural, and organisational factors influence hygiene practice.To understand variations between facilities and between people in hygiene behaviour and to explore potential intervention targets in four labour wards in Zanzibar.Site visits including observation of deliveries and of day-to-day workings of the facilities. Thirty-three semi-structured interviews, totalling more than 46 hours, with birth attendants, orderlies, managerial staff and mothers. Transcribed interviews and observation notes were read and coded by two authors. Themes were developed and analysed in light of existing research.The physical preconditions for hand hygiene were met more regularly in the two highvolume facilities, where soap, water, gloves were almost always available. However, in all of the facilities, hand hygiene appeared impeded by poor ergonomics, like, for example, physical distance between water taps, gloves, or delivery beds. Recontamination of gloved hands following good hand hygiene was commonly observed, a pattern that the birth attendants attributed to high and unpredictable workload and equipment shortages. Interviews and focus groups suggested that birth attendants typically understood when and why hand hygiene should be implemented, and that they were aware of low handwashing rates among co-workers. In poorer performing facilities, managers were less inclined to visit wards and more likely to perceive hand hygiene as beyond their influence.Observations and interviews suggest improvements in the ergonomic design of delivery rooms, including convenient availability of sinks, soap, hand gel, hand towels and gloves, may be a low-cost way to reduce the infection burden from poor hand hygiene. •We ran a mixed-methods study on clean birth practices in Zanzibar.•We interviewed 34 staff, observed 15 births, and spent 15 days in four facilities.•convenient.While gloves, soap, and handgel are often present, they are rarely •Midwives realise hygiene is low among colleagues not prioritised by management.•Improved ergonomics and norm change may help improve infection control. While hThere is therefore a need for feasible and effective interventions that improve hand hygiene and reduce the burden of preventable bacterial infections in both newborns and mothers. One obvious and necessary approach is to improve water, sanitation, and hygiene infrastructure. The layout and organisation of delivery rooms may play an important role in facilitating or impeding hygiene and infection control. While the effects of water shortages or broken taps are obvious, there may be a more subtle relationship between infection control and the ergonomics  of the delivery room. For example, even small increases in the distance between patient and sink can decrease handwash rates . MoreoveHANDS, a large multi-method project aimed at understanding hand hygiene in maternity wards. Site visits, that is, multi-day visits by a team of researchers to several sites . Facilities C and D were smaller and focused primarily on maternity and outpatient services.Site and participant sampling. The four facilities were selected from a sample of 10 which were included in the HANDS project. These four facilities were chosen to reflect the diversity across the delivery-volume spectrum, as well as an urban and rural spread. Quantitative assessment of hand hygiene in the 10 facilities suggests that these four facilities did vary in hand hygiene compliance . We paid particular attention to the delivery procedures, newborn care immediately after birth, and the management of infection risks during this process. Other tasks included organizing interviews, observing between-delivery preparation and cleaning, generally becoming acquainted with the facility and its staff members, asking questions about the layout and organisation, and observing daily life in the facility. This ethnographic approach was complemented by semi-structured observations.Semi-structured observations: Semi-structured observations were conducted in each facility in 30-min sessions. During these sessions, a researcher sat in the delivery room and observed one staff member. The researcher took detailed time-stamped notes on all hand-hygiene-related behaviour  and on the broader behaviour patterns of which the hygiene was a part . Semi-structured observation sessions were timed to coincide with deliveries or vaginal exams, and the focal staff member was chosen on the basis that they were ones who were delivering the baby or conducting the vaginal exam. These observations noted any deviations from the WHO-recommended hygiene practices. These are detailed elsewhere “It would have been better if the taps were available in every ward, it would have helped very much to make someone not forget to wash hands.” (Midwife).“If the sinks are available in every room, one cannot leave aside washing hands. However, when the sinks are far, one starts to think of going from here to there so one sees some sort of a burden.” (Nurse birth attendant.)There were substantial differences between facilities in how the layout of the delivery room and the consumables facilitated these hygienic practice. In some facilities, the time costs, energy costs, and mental costs of executing these steps was much higher than in other facilities. For instance, the layout of one facility necessitated a 32–34 step round-trip, including a door, to get from patient to tap to gloves to patient. Few gloves were kept in the delivery room, and an additional 40-step journey to retrieve more from the store cupboard in the next room was often necessary. The consequences of this layout were recognised by staff members as inappropriate, particular in a facility where the sink was outside the delivery room:“When your assistant comes to scan the cupboard for [i.e. retrieves] gloves, you have already touched the head of the baby [that has just been delivered].” (Nurse birth attendant.)During fast deliveries, there is insufficient time to find the gloves:The same set of tasks in another facility involved fewer steps . However, hand hygiene infrastructure/consumables were not located close to each other, nor were they arranged in the order in which they are typically used. In two facilities, there was no functional sink in the delivery room, and in one, the hand gel was kept in a separate storeroom. Thus, essential hand hygiene resources were invisible and inaccessible. Only in one facility were the sink, soap, drying material (gauze), and gloves kept within five steps of each other. “There should be enough hand washing stations, soap, and paper towels should be available. There also should be a hand washing station at least after two to three patients’ bed […] unnecessary movements will be reduced. […] [S]inks make it easy to remember to wash hands when observing patients.” (Ward manager.)The ward manager in facility A, a facility with better ergonomics, was sensitive to how the arrangement of sinks and other consumables can facilitate hygiene:“Maybe just the time, sometimes you are so busy it becomes difficult to go and find water and soap, you might find the mother is fully dilated and the baby is coming out, it becomes difficult to find the soap and wash hands in that situation.” (Nurse birth attendant..)Note how the ward manager recognised the role of sinks as physical reminders to engage in hand hygiene. Several birth attendants noted how the poor room organisation impeded performance during demanding periods:Theme 2: Attitudes, beliefs, and behaviours relating to consumable use.“Now if you do not have an assistant, you might take it if you draw that medicine and touch other things, sterility is broken, unless you prepare yourself with all the needed items on a tray close to the delivery bed.” (Nurse birth attendant.)Delivery packs: Delivery packs include forceps, blades/scissors for cutting the umbilical cord, a ligature for tying the cord, gauze and cotton swabs. In facility B, these were prepared in advance and wrapped in a sterile cloth, making workload more manageable for midwives just before a delivery, a critical time for hand hygiene. Facility D also prepared delivery packs in advance, but these were often incomplete, requiring birth attendants to search for sterilised tools immediately before or during the delivery. Midwives described discovering mid-delivery that key components were missing. Pre-prepared delivery packs necessitate several full sets of equipment, and the ward manager of facility C listed equipment shortage as a reason delivery packs were not always available. Midwives in Facility B noted the importance of a complete, convenient delivery pack for avoiding hand recontamination after hand hygiene:Soap and handwashing. Liquid soap bottles were present at least one sink in all of the labour wards (but sometimes not in the delivery room) during our observations. Birth attendants reported that liquid soap was absent for a few weeks several times a year, forcing the birth attendant to rely on cheaper powder soap that “dries your skin and causes irritation” (nurse birth attendant). Bar soap did not appear to be in use.“There are some women with infections and we as providers can't tell who it is. Therefore, in order not to infect yourself, when you remove gloves you have to wash your hands; and some gloves could be torn without you knowing so it is important to wash hands.” (Nurse birth attendant.)During observation periods, liquid soap was typically used after “dirty” procedures, where contamination with body fluids had occurred. In interviews, birth attendants often mentioned the importance of handwashing after such procedures for protecting themselves and other mothers:before aseptic procedures was less frequent than after procedures. During interviews, birth attendants described how such handwashing posed no major difficulty for them, except for during emergency deliveries:“There are emergency situations in which one may forget to wash hands, like when a pregnant woman comes fully dilated in which you just wear gloves and assist her. But that doesn't happen all the time, most women come not fully dilated.” (Nurse birth attendant.)“Yes, it is important, one can wash your hands, dry them and then wear gloves especially when the situation allows, but when a woman arrives here fully dilated, one just wears gloves.” (Orderly birth attendant.)Observation on the wards suggested that washing of hands “Up to five out of ten nurses can wash hands before a delivery … Eight to ten nurses could wash their hands after a delivery.” However, when asked during the interview to estimate the number out of 10 colleagues that washed hands before a delivery, responses ranged from 0 to 8, with many estimating that about half would wash hands before a delivery. Numeric estimates were similar for vaginal exams. Ward managers similarly understood hand hygiene was less than universal:Birth attendants explained this low compliance among peers as a consequence of laziness, lack of education, poor understanding of consequences, forgetfulness, negligence, and, consistent with the quotes above, time constraints.Hand gel sanitizer. Facility B was observed to make its own hand sanitizer and was the only facility where it was readily accessible and often used. While there were no religious concerns among the largely Muslim staff about alcohol gel use, there appeared to be some doubt about its effectiveness. One midwife described how it might be appropriate to use “when we want to do minor procedures, but not during delivery”. Another birth attendant described it as useful in an emergency rather than as a standard replacement for water/soap before aseptic procedures:“We use soap and water if we see that there is still time before a mother delivers, if the mother is almost ready to deliver when she comes then we use hand gel.” (Nurse birth attendant.)Drying materials and hand drying. Wet hands are difficult to glove, and the sensation of wearing gloves over wet hands is unpleasant. During the observation periods, we noted that the absence of convenient, disposable hand drying materials created difficulty for the birth attendants. We observed air drying of hands  and as well as the use of personal handkerchiefs, cotton gauze, or the front of the uniform to dry hands. Birth attendants mentioned that staff members do not wash hands before a vaginal exam “since they don't have drying materials” (Midwife.)Gloves and their use. During our observations, glove use during aseptic procedures was universal, but contamination of gloved hands was common.Birth attendants sometimes layered multiple pairs of gloves, removing the top layer after one procedure and continuing to the next procedure using the inner layer. This layering of glove use was observed in multiple facilities and described by multiple birth attendants. There were differences in when the top layer is removed with some shedding the top layer to “receive the child” and most others shedding to cut the umbilical cord. Birth attendants also reported layering gloves so that they could efficiently attend to multiple patients.While the woman is getting down from the bed, the mackintosh falls down on the floor.Contamination of gloved hands through contact with potentially infective surfaces was common during observations. In interviews, birth attendants mentioned that contact with objects such as tables, drawer handles, the mother's kanga, the injectable oxytocin, the drip, unsterilised Cheatle forceps, and syringe boxes, as well as the mother was common and that they could lead to infection transmission. While some midwifes made relatively little effort to avoid recontamination, others tried but were often unsuccessful. Our observations illustrate this:Nurse A picks the mackintosh up with her sterile gloves on .The birth attendant puts on two pairs of sterile gloves and asks the mother to lay in a proper position. She uses the sterile gloves wrapping to hold the mackintosh and put it properly.Or:[to avoid contamination] you have to prepare yourself well; when a mother is about to deliver before wearing gloves you put all equipment in place. We have folded the delivery sets on green towel so that each worker can use a set which is complete and not the set with missing equipment, this will avoid one from looking for thing unnecessarily.”At facility B, nurse birth attendants reported on how preparation can prevent glove recontamination:Delivery surfaces: kanga and mackintosh. Delivery beds were covered with a mackintosh (a plastic sheet), which was covered with a kanga (a multipurpose cotton rectangle) during labour and delivery. These were both brought to the facility by the mother. Kangas were brought from home while mackintoshes were purchased from nearby pharmacies. Selling mackintoshes to mothers was discouraged by some managers who were concerned about accusations that facility gained from sales: “trouble comes in when she sells the things to a person who feels that the equipment is available, but it is being sold to her” .After the delivery, the woman's kanga was used to clean the vagina/perineum in three of the four facilities (facility C used cotton gauzes). The use of often-soiled kanga to clean the vagina after birth may pose a significant infection risk. After the placenta had been delivered, another kanga was sometimes used as a makeshift sanitary pad. A separate kanga was also used to wipe clean and then wrap the baby after delivery.3.3Social norms and social sanctions. Birth attendants reported that hand hygiene compliance among colleagues was often low. Birth attendants also reported that negative consequences for those who do not handwash were generally absent:Have you heard of any complaints about health providers who do not wash hands before assisting women to deliver?”Interviewer: ““I have never heard of such complaints, not only from here but from other hospitals as well, no woman has complained of being attended by a doctor who didn't observe hand hygiene while assisting mothers during delivery”.Orderly birth attendant: “We do not give punishments because we are all adults, we just remind each other.” One midwife in facility D hinted at how loyalty to one another precluded reporting poor hygiene:“Have you ever reported your colleague that he/she is not washing hands?”Interviewer: “There are no such customs and there is a habit of looking after one another.”Midwife: Sanctioning was seen by birth attendants as demeaning and childlike with one midwife in facility D reporting that Indeed, in all facilities, we observed a notable degree of mutual respect between staff members of different cadres. Senior staff members treated all staff, including orderlies, with politeness and kindness.Facility organisation and management. Several managerial/organisational characteristics appeared to distinguish poorer performing facilities from better facilities. In facility B, staff members were given specific tasks by their superiors  in the morning. In the other facilities, the division of roles was less clear. The specificity of roles and the fact that named individuals took responsibility for their completion may have contributed to the better organisation observed in facility B.We do nothing; it is a person's concern.”  compared to the other two (C and D). In the following sections, we discuss what factors may account for the differences between individuals and facilities and what this means for infection prevention strategies in Zanzibar and beyond.4.1When hand hygiene is time-consuming, it is likely that birth attendants will engage in it less frequently. Birth attendants have many demands on their time and attention and whether they choose to spend time on hand hygiene, or some other important task should depend on the time/energy costs of a given handwash. Findings from A similar absence of towels for hand drying was noted in 9 of 10 maternity wards studied in Cambodia  and all cognitive as well as a time cost imposed by the layout of the delivery rooms. Seeing an object in the right place at the right time can remind one of the appropriate next step in a sequence of actions (what do I do next?) and search tasks (where are the towels?) onto the environment. The cognitive costs of planning/searching in hand hygiene tasks are not trivial since hygiene tasks occur many dozen times per day and are especially critical during emergencies when cognitive resources are allocated to solving other complex problems  and infrastructure (sinks or tables) buttress particular behaviour patterns. Interventions that change these props or infrastructure can lead to sustained behaviour change because behaviour is often automatic and habitual response to these elements of the environment. However, such interventions need to be rooted in a detailed understanding of the interaction between behaviour and environment . While we doubt the results would have been qualitatively different had we recorded this data, these kinds of precise measurements would have enabled comparisons with other studies and settings.With just four facilities and a subset of people within each one, we cannot draw any firm conclusions about the causes of different hygiene rates. The problem is exacerbated by the fact that many of the “good” things were common in the better-performing facilities and missing from the poorly performing facilities . It is unclear how well these findings and recommendations generalise to other facilities in Tanzania or indeed lower-incomes settings across the globe.A strength of the study is that it provides a rare and detailed exploration of how hand hygiene and delivery ward organisation/layout interact in a low-income setting. As 5Our results suggest several potential ways to make hand hygiene easier to perform and less time-consuming through relatively low-cost changes to maternity wards. Providing personal supplies of antiseptic hand gel and locating hand washing facilities, including disposable hand towels, in places that fit with workflow at the time of delivery are promising interventions. Such changes could substantially reduce the time and effort needed to maintain compliance with hand hygiene standards without imposing undue time costs on staff members and deterioration of patient care.Mícheál de Barra: Writing - Original Draft, Formal analysis, Investigation. Giorgia Gon: Conceptualization; Formal analysis, Writing - Review & Editing, Investigation. Susannah Woodd: Conceptualization, Formal analysis, Writing - Review & Editing. Wendy J Graham: Conceptualization, Supervision, Writing - Review & Editing. Marijn de Bruin: Conceptualization, Supervision, Writing - Review & Editing. Catherine Kahabuka: Investigation, Formal analysis. Jess Williams: Formal analysis. Khadidja Konate: Visualization. Said M Ali: Project administration, Investigation, Conceptualization. Rukaiya Said: Project administration. Loveday Penn-Kekana: Investigation, Supervision, Writing - Review & Editing.


Introduction: Worldwide cesarean birth had increased over the past three decades and in the USA, the overall rate of cesarean birth has increased from 23.8% in 1989 to 31.9% in 2018. Moreover, the substantial increase of preterm infants delivered by cesarean section had reached anywhere from 45% to 72% for gestational age <33 weeks. There is a considerable debate on whether cesarean section confers a survival advantage for preterm infants. Published data on the relationship between mode of delivery and survival rate were inconsistent and there is a lack of large randomized controlled trials (RCTs) that have investigated this important clinical concern. Thus, the aim of this study is to evaluate the impact of cesarean section on the survival rate of very low birth weight (VLBW) infants.Methods: This was a retrospective cohort study of ≤32 weeks VLBW infants born alive and admitted to Neonatal Intensive Care Unit (NICU) at King Abdulaziz Medical City-Jeddah (KAMC-Jeddah) between January 1, 1994, and December 31, 2019. The primary outcome of interest was the survival rate to discharge of VLBW infants delivered by cesarean section compared to delivered vaginally. Relevant demographic and clinical variables were assessed and its association to survival to discharge of VLBW infants were analyzed.Results: Of the 1055 ≤32 weeks VLBW infants included in the study, 559 (53%) were delivered by cesarean section, and 496 (47%) were delivered vaginally. Cesarean delivery had increased from 44.2% to 66% between 1994-1998 and 2014-2019, respectively. The rise of cesarean delivery compared with the vaginal delivery was more profound for gestational age ≤26 weeks and birth weight ≤800 g. The VLBW infants delivered by cesarean section had a higher survival rate when compared to infants delivered vaginally . The survival advantage was statistically significant in extremely low birth weight (ELBW) infants (801-1000 g) and infants with birth weight ≤800 g, 86.73% vs 73.62%, P=0.018 and 58.02% vs 40.52, P=0.001, respectively. Moreover, VLBW infants ≤26 weeks gestational age delivered by cesarean section had a higher survival rate of 69.15% vs 44.5%, P<0.001.Conclusion: This study demonstrates that cesarean birth is associated with higher survival for VLBW infants with birth weight ≤800 g and ELBW infants and gestational age ≤26 weeks compared to vaginal birth. Worldwide cesarean birth had increased over the past three decades  and in tThere is a considerable debate on whether cesarean section confers a survival advantage for preterm infants. Published data on the relationship between mode of delivery and survival rate were inconsistent and there is a lack of large randomized controlled trials (RCTs) that have investigated this important clinical concern. Nevertheless, cesarean delivery has been shown to improve the outcome of very low birth weight (VLBW) infants in certain clinical settings like non-vertex fetal presentation and growth-restricted premature infants .There have been two Cochrane reviews that evaluated the role of elective cesarean section versus expectant management and also the impact of cesarean section versus vaginal delivery for preterm birth outcomes; however, these reviews did not find evidence that using cesarean delivery policy would improve outcomes and concluded that the difference between the two groups on mortality was not significant ,7. The mWe performed a retrospective cohort study of VLBW infants admitted to Neonatal Intensive Care Unit (NICU) at King Abdulaziz Medical City-Jeddah (KAMC-Jeddah) between January 1, 1994, and December 31, 2019. Perinatal and neonatal data were collected from the unit admission registry and patient medical records were reviewed to ensure completeness and accuracy of the collected data.The analysis includes VLBW infants who were born alive with gestational age ≤32 weeks. Infants with lethal/complex congenital anomalies or gestational age >32 weeks were excluded from the analysis. The primary outcome of interest was the survival rate to discharge of VLBW infants delivered by cesarean section compared to delivered vaginally. Relevant demographic and clinical variables including the rate of antenatal care, use of antenatal corticosteroid, gestational age (weeks), birth weight (grams), mode of delivery, use of exogenous surfactant, and survival to discharge were collected.Differences between the two groups were compared using Student’s T-test for the unequal variance of continuous data or Chi-square and Fisher’s exact test for categorical data as appropriate at a threshold P-value of <0.05. The statistical analysis was performed using the Statistical Package for Social Sciences (SPSS), version 23.0 .A total of 1055 VLBW infants were identified and met the study inclusion criteria for analysis Figure . The risCesarean section delivery was significantly higher in female compared to male infants, 304/527 (57.7%) vs 223/528 (42.3%), P=0.002. There was no difference between the two groups in the rate of antenatal care, the use of antenatal corticosteroid and surfactant. Infants delivered by caesarian section were of higher gestational age, 29.02 ±2.17 weeks and heavier birth weight (1100±250 g) compared with the gestational age of 27.49 (2.56) weeks and birth weight of 1010±300 g among infants delivered vaginally . The survival advantage was statistically significant in ELBW infants (801-1000 g) and infants with birth weight ≤800 g, 86.73% vs 73.62%, P=0.018 and 58.02% vs 40.52, P =0.001, respectively. Moreover, VLBW infants of ≤26 weeks gestational age delivered by cesarean section had a higher survival rate of 69.15% vs 44.5%, P<0.001. The survival rate of VLBW was not statistically significant between the two groups for gestational age >26 weeks and birth weight >1000 g , but these were not statistically significant. Nevertheless, both male and female VLBW infants delivered by cesarean section had significantly higher survival when compared to infants delivered vaginally if they were evaluated separately .This study found VLBW infants delivered by cesarean section had a higher survival rate than the ones delivered vaginally. The survival advantage was more profound in infants with birth weight ≤800 g and to a lesser extent ELBW infants. There was no difference in survival among the two groups with birth weight between 1001 and 1500 g. Moreover, infants with gestational age ≤26 weeks had a significantly higher survival rate if delivered by cesarean section, however, no difference for gestational age >26 weeks. This has been reported by Holzer et al. wherein appropriate for gestational age infants with gestational age between 23 and 28 weeks had better outcomes after cesarean section delivery (P<0.001 for 23-24 weeks and P=0.001 for 25-28 weeks) . This waMuhuri et al. published an article where he found that among breach/malpresenting preterm infants delivered by primary cesarean section, significantly lower adjusted relative risk for death compared to those delivered vaginally, but vertex presenting neonates results were mixed suggesting decreased relative risk for mortality for those of birth weight <750 g but not significant for 750 - 999 g weight group .Thanh et al. published an article reflecting a secondary analysis of the WHO global survey and Multicountry Survey (MCS) database to investigate the effect of mode of delivery on the outcomes of preterm birth by mode of delivery. The results relevant to our study that compared vaginal birth to cesarean section were associated with significantly decreased fresh stillbirth and perinatal deaths in preterm birth with gestational age between 22 and 37 weeks but associated with higher maternal and neonatal ICU admissions. Hence, the justification for the preferred mode of delivery should be carefully considered when deciding the mode of delivery for preterm infants .Prospective RCTs are the scientific method to alleviate the dilemma of the cesarean section delivery benefit vs vaginal birth for preterm infants’ debate; however, such trials are not currently feasible in order to reach a solid conclusion particularly for vertex presenting preterm fetuses. The hypothetical advantages for cesarean birth vs vaginal route are to avoid prolonged labor, and possibly less traumatic is the suggested benefit factor; nevertheless, this controversial topic among the obstetric and neonatal community was debated over the past two decades but clear and solid recommendations are difficult to reach yet.There are several limitations to our study. For its retrospective nature, some perinatal variables of importance were not included. The data neither distinguish between emergency and elective cesarean birth nor did include information on the specific indications for performing cesarean section or fetal presentation whether it was vertex or non-vertex, and all these variables are important when the method of delivery is considered.This study demonstrates that cesarean birth is associated with higher survival for VLBW infants with birth weight ≤800 g and ELBW infants and gestational age ≤26 weeks compared to vaginal birth. VLBW infants of gestational age >26 weeks and birth weight more than 1000 g had no difference in survival rate between the two groups. Further studies are needed to further characterize the important factors and clinical variables that may affect the outcome of VLBW infants based on the method of delivery.


The objectives of this study were to describe the methods used to assess the quality of linkage between records of babies’ birth registration and hospital birth records, and to evaluate the potential bias that may be introduced because of these methods.Data from the civil registration and the notification of births previously linked by the Office for National Statistics (ONS) had been further linked to birth records from the Hospital Episode Statistics (HES) for babies born in England. We developed a deterministic, six-stage algorithm to assess the quality of this linkage.All 1 170 790 live, singleton births, occurring in National Health Service hospitals in England between 1 January 2005 and 31 December 2006.The primary outcome was the number of successful links between ONS birth records and HES birth records. Rates of successful linkage were calculated for the cohort and the characteristics associated with unsuccessful linkage were identified.Approximately 92% (1 074 572) of the birth registration records were successfully linked with a HES birth record. Data quality and completeness were somewhat poorer in HES birth records compared with linked birth registration and birth notification records. The quality assurance algorithms identified 1456 incorrect linkages (<1%). Compared with the linked dataset, birth records were more likely to be unlinked if babies were of white ethnic origin; born to unmarried mothers; born in East England, London, North West England or the West Midlands; or born in March.It is possible to link administrative datasets to create large cohorts, allowing researchers to explore important questions about exposures and childhood outcomes. Missing data, coding errors and inconsistencies mean it is important that the quality of linkage is assessed prior to analysis. This is the first study to evaluate the linkage of birth registration, birth notification and Hospital Episode Statistics (HES) birth records in England.We were able to build on existing work relating to the quality assurance of birth registration, birth notification and HES delivery records.Access to personal identifiers meant that we were able to evaluate the quality of linkage, identify poor quality matches and assess the level of bias introduced by linking these datasets.Accessing personal identifiers also led to delays because of the length of approval processes and the need to travel to access these data in designated secure settings. However, the Office for National Statistics is developing a remote access system for the secure setting, so future research studies may not be affected by the need to travel.We examined only singleton births in National Health Service hospitals so we did not assess whether the linkage of multiple births is of comparable quality. However, previous work linking birth registration records with mothers’ delivery records in multiples suggests that the linkage rate is similar to that for singletons.The use of routinely collected datasets within research has increased rapidly over the past decade as an alternative to conducting large, observational studies, which can be extremely costly and often suffer from poor recruitment and retention rates.The Digital Economy Act 2017The work described in this paper was conducted as part of the  TIGAR study, which is a population-based, record-linkage study of births and hospital admission data in England. The study aimed to estimate the association between gestational age at birth and rates of hospital admission throughout childhood. This used previously linked data from two sources.6Two HES records are generated when a baby is born in England; one for the mother and one for each baby. Each consists of an Admitted Patient Care (APC) record common to all hospital in-patient stays plus a ‘tail’ with information about the birth . The mot10.1136/bmjopen-2020-037885.supp1Supplementary dataThe team at City, University of London, has already evaluated the quality of linkage between birth registration, birth notification and the mother’s HES delivery records for births from 2005 to 2014. The authors reported a linkage rate of 95% and uncovered some linkage errors.All live, singleton babies born in NHS hospitals between 1 January 2005 and 31 December 2006 to a mother living in England were eligible for inclusion in this study cohort. The analysis was restricted to births in NHS hospitals, but they accounted for 96.6% of women giving birth in 2006. Home births accounted for 2.7% of deliveries in 2006, but although most received NHS care, many were not recorded on hospital systems and so not included in HES. There were extremely few HES records for the 0.5% of deliveries in non-NHS hospitals and the 0.2% delivering elsewhere.8All analyses were conducted using STATA V.14Two datasets containing data about births in England from 1 January 2005 to 31 December 2006 were linked . They and the linkage file were saved as three separate STATA datasets. The datasets included: (1) ONS births; (2) HES birth records; and (3) the linkage file containing unique ONS birth identifiers (ONSID) and corresponding unique HES identifiers (HESID). These files are described in the The master dataset comprises data from two sources: birth registration and birth notification. These two datasets have been routinely linked by the ONS since 2006 and the combined dataset is referred to as ‘ONS births’ throughout this paper. ONS births contains personal identifiers, sociodemographic characteristics and birth characteristics.10HES is a large database containing records of all episodes of care and births in NHS hospitals in England since 1989. The records used here are from the HES APC dataset, which contains records of all inpatient admissions, including birth and delivery records, to NHS hospitals across England. A full description of the database can be found elsewhere.Everyone for whom records are stored in HES is assigned a unique identifier, called the HESID.13When a baby is born, the general inpatient episode becomes part of the Maternity HES dataset and 19 additional variables relating to the delivery or birth are appended. For each birth, two maternity HES records are generated. First, a HES delivery record, which includes the general inpatient record for the mother and 19 additional variables, referred to as the maternity tail. Second, a HES birth record, which includes the general inpatient record for the baby, along with 19 additional variables, referred to as the baby tail. The maternity and baby tails contain similar information relating to the delivery and birth; however, this study evaluated the linkage of HES birth records only. These additional data items in the baby tail include variables such as gestational age at birth and neonatal level of care. For a full list, see section A in the The linkage file contained the unique identifiers from each dataset as linked by NHS Digital. The dataset contained unique identifiers from ONS births (ONSID) that had been successfully linked with the corresponding unique identifier from HES births (HESID) and those which had not. It also contained unique HES birth identifiers that were not linked to a unique ONS birth identifier.Linkage between ONS birth records and HES birth records is a two-step process. First, ONS birth records were linked to the HES patient index  by NHS Digital using a deterministic algorithm in order to assign the HESID; and second, records were linked to the corresponding HES birth records using the HESID and other identifiers.Full details of available variables, data cleaning procedures and preparation steps for the included datasets are described elsewhere.Birth episodes with the same HESID can occur due to a number of reasons: (1) unfinished episodes, such as a baby being born on the 30 March, but then discharged on the 1 AprilAfter merging the three datasets, we identified cases where two different ONS birth records had been linked to the same HES birth record and key characteristics were compared to identify the correct link. This was done by comparing the following variables which were available in both data sources: baby’s date of birth, gestational age, birth weight, sex, mother’s date of birth and postcode. The record with the highest number of matching variables was identified as the correct link. When records matched on the same number of variables, the record that matched exactly on birth weight was identified as the correct match. If birth weight was missing or did not match with either record, then the record with the highest match rank score from the original linkage  was idenThe deterministic algorithm developed for evaluating the record linkage is summarised in Final checks after the QA procedures were completed included: (1) checking that the baby’s date of birth in ONS births was within the admission and discharge dates from the HES birth record; (2) baby’s date of birth in ONS births did not occur before 1 January 2005 or after 31 December 2006; (3) hospital discharge date did not occur before the admission date; and (4) further checks to ensure that all stillbirths had been excluded  diagnosis code=Z37.1).2 test was used to assess whether distributions differed significantly between the linked and unlinked study samples. Because the sample sizes were so large, we also looked at differences in distributions of variables, for example, differences between proportions of more than 1%. In addition to this, we compared the distributions of key characteristics between the linked study sample and all live births in England in 2005 and 2006 to see what effect excluding stillbirths, multiple and non-NHS births had on the study cohort.The distributions of key characteristics were compared between the linked and unlinked study samples and the eligible study sample. The χThe TIGAR study was supported by a patient, parent and public advisory group, which provided input to different aspects of the study. This group met at the start of the study and gave input into the study protocol and the lay summary of the project.There were 1 257 884 ONS birth records. After excluding multiple births and babies who were not eligible for the TIGAR study, 1 170 790 live, singleton babies born from 1 January 2005 to 31 December 2006 in NHS hospitals to women living in England remained in the study cohort. There were 1 243 373 HES birth records and the linkage file included 1 242 938 records .Of the 1 170 790 eligible ONS birth records, 1 074 571 (92%) were successfully linked with a HES birth record. Of the 96 219 unlinked records, 88 471 had a HESID but no corresponding HES birth record and 7747 had no corresponding HESID in the linkage file. The majority of records linked had a match rank score of one, which meant they exactly matched on all four variables in the NHS Digital algorithm, with fewer than 1% of records linking in stages 3–6 of the algorithm . A higheAll key variables in ONS birth records had data missing for less than 1% of births. In contrast, data were missing from substantial numbers of HES birth records Of the 1 243 373 HES birth records, 73 307 (6%) had linked with more than one record with the same HESID. Of these, the most common reasons for this were multiple episodes within a hospital spell (62%), unfinished episodes (15%) and duplicate episodes due to administrative errors 11%; . There wA total of 979 (0.1%) HES birth records had linked with more than one ONS birth record. The high proportion of missing data in HES birth records meant that it was difficult in many cases to identify the correct match. Of these, 499 records were judged to be incorrectly linked and were broken. It was not possible to ascertain the status of 95 records, which had the same matching variables and match rank score. A lot of data items in these records were missing data and all were excluded .Key variables of the 1 074 571 (92%) ONS birth records which had been successfully linked were then compared using the algorithm in Overall, 860 records with incorrect links were identified and 64% of these were in births in 2005, suggesting an improvement in data and linkage quality in 2006. When exploring these broken links in relation to their match rank score, 69% had a score of six, meaning their NHS numbers were missing. The main reasons for broken links were completely different dates of birth, as opposed to exact or partial matching, and data missing for large numbers of variables. Among these records, birth weight, gestational age, postcode and mother’s date of birth was missing for approximately 92%, 91%, 85% and 91%, respectively. There were a small number of records that appeared to be incorrectly broken due to cleaning errors, for example, postcodes which included an ‘O’ instead of a zero.A number of interesting observations were made when reviewing the broken links: (1) many that were broken differed by gestational age, but in most cases by just 1 week and the babies were full term, for example, 39 and 40 weeks; and (2) more than one-third of broken links were for babies born in London. As the numbers of broken links were small, distributions of numbers of broken links cannot be presented, as they could be disclosive.Distributions of key variables for all live births, all eligible births and all linked and unlinked births are presented in Our study has shown that linkage between ONS births and HES births, based on NHS number; baby’s date of birth, sex and postcode, is possible. Overall, 92% of ONS birth records for live, singleton births born in NHS hospitals to mothers living in England were successfully linked to a HES birth record. After checking the quality of linkage in two stages, 1456 records (<1%) were identified as potentially incorrect links. The main reasons for breaking links were different dates of birth and large amounts of data missing from key fields, making it difficult to determine if the link was correct. A higher proportion of links was broken for births in 2005 compared with births in 2006, suggesting an improvement in data quality between the two years. The addition of partially matching date of birth in the QA algorithm increased sensitivity and identified more correct linkages, which would have otherwise been missed from the study cohort.Duplicate HES records and large amounts of data missing for some variables created challenges when assessing linkage quality, highlighting the importance of these procedures before beginning statistical analysis. Finally, birth records were more likely to not link if babies were of white, British ethnic origin, born outside marriage, born in East England, London, North West England or the West Midlands, or born in March.Key strengths of this study included building on previous work conducted into the linkage of mothers’ hospital records with babies’ birth records, obtaining data from multiple sources, and the use of personal identifiers, which allowed us to evaluate the linkage more easily. However, the need to access personal identifiers also increased the problems involved in accessing the data, notably in terms of the length of approvals processes. Other limitations include the restriction of the assessment of linkage to live, singleton births in 2005 and 2006. We were unable to assess how well the algorithms designed for this study would perform with multiple births. These tend to have more complex data, although similar algorithms were successfully used for the quality of assurance of the linkage of multiple births to mothers’ delivery records.15 16Approximately 8% of ONS birth records did not link to a HES birth record. One of the key reasons for unlinked records appeared to be missing data in key linking fields. Quality and completeness are always a concern when using routinely collected datasets and the large sample sizes they provide are always traded off with these limitations. Data quality was somewhat poorer in HES birth records than in ONS birth records and this is a commonly cited issue when working with HES data.7Compared with the full linked dataset, records of babies born in East England, North West England, London or the West Midlands were more likely to not link. It is likely that these variations are due to differences between hospital trusts in the ways in which definitions or protocols are used, because errors occur during the transfer of data from one organisation to another, or in the overall quality of Maternity HES for certain hospitals. It is also possible that regional reporting differences account for the higher proportion of white babies and births outside marriage in the unlinked dataset. Babies born in March were also more likely to have unlinked records and this was also the case with the mothers’ HES delivery records.We found a small proportion of records that were potentially incorrect linkages, suggesting that linkage performed by ‘Trusted Third Parties’, such as NHS Digital, may not be 100% accurate. Therefore, it is essential that researchers understand the quality of linkage undertaken by a Trusted Third Party prior to performing any statistical analysis. While the responsibility should fall to the Trusted Third Party to conduct quality assessment of its linkage methods and make them publicly available to researchers, this does not happen in practice.The findings in this paper will offer some insight into the quality of linkage between ONS birth and HES birth records and be of use to other researchers using the same linkage. As the quality and completeness of HES improved over time, it is likely that the quality of linkage will also have improved as a consequence, but the signs that the improvement in quality may not have been sustained is worrying.The findings from this study have demonstrated a need for Trusted Third Parties to evaluate linkage methods and publish findings for researchers to use prior to beginning statistical analysis. In cases where this is not possible, a number of studies have shown that datasets can be linked using deidentified datasets and produce generalisable cohorts; therefore, future work could explore ways to quality assure linkage without using personal identifiers. This will increase the likelihood of easier data access, potentially reducing the time required to complete the linkage and cleaning of routinely collected datasets. Finally, we did not assess whether the quality of linkage for multiples is comparable with live, singleton, NHS hospital births although QA of the linkage of multiple births to mothers’ delivery records suggested that it was better than had been initially assumed.6By linking together administrative datasets, such as birth registration, birth notification and hospital admission data, it is possible to create more complete datasets about births which can then be linked to other administrative datasets to look at longer term outcomes.