Does knowledge of cervical length and fetal fibronectin affect management of women with threatened preterm labor? A randomized trial. A randomized trial of cerclage vs. 17 alpha-hydroxyprogesterone caproate for treatment of short cervix. Routine ultrasound fetal examination in pregnancy: the 'Alesund' randomized controlled trial. Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery. Efficacy of a single oral dose of 200,000 IU of oil-soluble vitamin A in measles-associated morbidity. The role of Doppler velocimetry in the management of high risk pregnancies. Impact of a regional screening programme using maternal serum alpha fetoprotein (AFP) and human chorionic gonadotrophin (hCG) on the birth incidence of Down's syndrome in the west of Scotland. Failure of metronidazole to prevent preterm delivery among pregnant women with asymptomatic Trichomonas vaginalis infection. Effectiveness of nurses as providers of birth labor support in North American hospitals: a randomized controlled trial. Nevirapine-associated toxicity in HIV-infected Thai men and women, including pregnant women. The year-long effect of HIV-positive test results on pregnancy intentions, contraceptive use, and pregnancy incidence among Malawian women.
The purpose of this study was to estimate the effect of sonographic cervical length (CL) and fetal fibronectin (FFN) on length of evaluation and outcomes in women with preterm labor (PTL).
                Women with threatened PTL were randomized to either a knowledge group (results of CL and FFN available and used according to study protocol), or a standard group (blinded to CL and FFN). Primary outcome was length of evaluation in triage.
                One hundred women were randomized. There was no significant difference between groups in length of evaluation, but in women with CL > or = 30 mm, the mean time for evaluation was significantly shorter in the knowledge group (1:58 h +/- 0:50 vs 2:53 h +/- 0:50, P = .004). Incidence of spontaneous preterm birth (SPTB) in the knowledge group was significantly reduced (13.0 vs 36.2%, P = .01).
                The knowledge of CL and FFN was associated with reduction in length of evaluation in women with CL > or = 30 mm and in incidence of SPTB in all women with PTL. To determine pregnancy outcome in patients with short cervix on transvaginal ultrasound between 16 and 24 weeks' gestation treated with McDonald cerclage compared to weekly intramuscular injections of 17 alpha-hydroxyprogesterone caproate (17OHP-C).
                From November 2003 through December 2006, asymptomatic, singleton pregnancies were screened with transvaginal ultrasound between 16-24 weeks' gestation. Patients with a cervical length (CL) < or =25 mm were offered enrollment. Patients were randomly assigned to treatment with McDonald cerclage or weekly intramuscular injections of 17OHP-C. The primary outcome was spontaneous preterm birth (PTB) prior to 35 weeks' gestation.
                Seventy-nine patients met inclusion criteria; 42 were randomly assigned to the cerclage and 37 to 17OHP-C. Spontaneous PTB prior to 35 weeks' gestation occurred in 16/42 (38.1%) of the cerclage group and in 16/37 (43.2%) of the 17OHP-C group (relative risk, 1.14 95% CI, 0.67, 1.93). A post hoc analysis of patients with a prior PTB showed no difference in spontaneous PTB <35 weeks between groups. A similar analysis of patients with a CL< or =15 mm showed a reduction in spontaneous PTB <35 weeks in the cerclage group (relative risk 0.48, 0.24-0.97).
                Women with CL < or =25 mm in the second-trimester appear to have similar risks of delivering prior to 35 weeks' gestation when treated with 17OHP-C or McDonald cerclage. However, cerclage may be more effective in preventing spontaneous PTB in women with CL< or =15 mm. To evaluate the possible benefits of the routine use of ultrasound screening in pregnancy.
                A randomized controlled trial was designed to detect a 50% difference in the incidence of induction for apparent post-term pregnancies between women who were screened with ultrasound and unscreened women. A total of 1628 pregnant women from the general population were included. Eight hundred and twenty-five were allocated to an ultrasound examination at the 18th and 32nd week of pregnancy in addition to receiving routine antenatal care. The remaining 803 women received standard antenatal care, but could only be referred for ultrasound examination on clinical indication.
                The incidence of induced labor due to apparent post-term pregnancies was approximately 70% lower in the ultrasound-screened group. Inductions from all causes were also less frequent among ultrasound-screened women. There were six perinatal deaths among the screened and seven among the controls after excluding three lethal malformations among the controls. There was no difference in Apgar score after 1 min, but the proportion with Apgar score less than 8 after 5 min was lower among the screened group (P = 0.04). The need for positive pressure ventilation for more than 1 min was lower among the screened group (P = 0.02). Birth weight was slightly higher in the screened group (39 g), but the difference was not statistically significant. Among the controls three pairs of twins remained undiagnosed until the mothers were admitted to the hospital in labor at between 36 and 38 weeks gestation.
                These results suggest that for women who were screened with ultrasound, obstetricians were less likely to induce labor due to apparent post-term pregnancy, than for women who were not screened. All 10 pairs of twins in the screened group were diagnosed at the routine examination. These data also suggest that perinatal morbidity might be slightly lower in the screened group. To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.
                Multicentre, prospective, randomised controlled trial.
                Non-hospital based antenatal clinics.
                4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.
                The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.
                Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and <or= 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.
                Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women. The authors assessed the efficacy of the World Health Organization (WHO) recommendation of 200,000 IU of vitamin A in oil to treat acute non-xerophthalmic measles patients. Acute measles patients who did not require hospitalization were enrolled in a randomized, double-masked, clinical trial of vitamin A (n=90) versus placebo (n=110) carried out in Ndola, Zambia, in 1991. Measles-associated morbidity was defined by the presence of signs and symptoms of acute respiratory infection. Daily evaluations for the first 3 days were followed by weekly visits for a month at urban health centers. Baseline demographic, clinical, and biochemical characteristics were similar in both groups. Cross-sectional analysis of morbidity status, by group, at each weekly evaluation showed no significant differences until week 4, when more placebo-treated patients had cough or pneumonia (p=0.005). However, longitudinal analysis, which looked at changes among individuals and controlled for initial health status, showed more equivocal results. The odds ratio for the development of pneumonia in patients with measles cough in vitamin A-treated subjects was 0.73 (95% confidence interval (Cl) 0.30-1.80). The odds ratio for the development of measles-associated cough or pneumonia in asymptomatic measles patients was 0.52 (95% Cl 0.24-1.13), in favor of vitamin A, but the odds ratio for failing to improve from pneumonia in vitamin A-treated subjects was 1.23 (95% Cl 0.68-2.3), a result in favor of placebo. These results suggest that the evidence for the efficacy of one dose of vitamin A in oil to prevent measles complications is not as strong as that previously shown for two 200,000 IU doses of water-miscible vitamin A, and that the WHO recommendation may need to be reexamined. To determine whether knowledge of the result of Doppler velocimetry of the umbilical artery is beneficial to the management of a high risk pregnancy.
                Randomised controlled trial. The trial was of the management type, designed to assess benefit accruing from additional information supplied by Doppler velocimetry.
                Tygerberg Hospital, Cape Town, South Africa. The hospital serves a population from the lower socio-economic groups.
                Women with pregnancies 28 or more weeks gestation with hypertensive diseases and/or suspected small for gestational age fetuses were referred for Doppler velocimetry. From this population, three subsets were formed: 1. those with fetuses with absent end-diastolic velocities (20 fetuses); 2. those with hypertension but with fetuses with end-diastolic velocities (89 fetuses); and 3. those with fetuses suspected of being small for gestational age but with end-diastolic velocities (104 fetuses).
                Doppler velocimetry on all subjects. The study group consisted of 10 cases with absent end-diastolic velocities, 47 cases with hypertensive diseases with end-diastolic velocities and 51 cases with suspected small for gestational age fetuses but with end-diastolic velocities in which the result was revealed to the clinician. The control group consisted of 10, 42 and 53 cases, respectively, in which the Doppler results were not revealed. All other routine investigations (sonar and antenatal fetal heart rate monitoring) were available to the clinicians. Standard management protocols were followed in all groups.
                Perinatal mortality and morbidity, antenatal hospitalisation, maternal intervention, admission to the neonatal intensive care unit and hospitalisation until discharge from the neonatal wards.
                In the study and control groups the gestational age at entry to the study, maternal age, parity and various complications were not significantly different. In the subset with absent end-diastolic velocities, there was one neonatal death in the study group, but in the control group there were six deaths, five intrauterine and one perinatally related infant death (P = 0.029). Because of this significant finding, the study was stopped. There were no differences in outcome in the subset where there was hypertensive disease with end-diastolic velocities between the study and control groups. In the subset in which small for gestational age fetuses were suspected, but in which end-diastolic velocities were present, the women in the study group had significantly fewer days in hospital before delivery (P < 0.001) and tended to have fewer maternal interventions (study group = 27%, control group = 43%; P = 0.07; odds ratio (OR) 0.49, 95% confidence limits (CL) 0.2 and 1.25) and caesarean sections (study group = 13%, control group = 27%; P = 0.08; OR 0.43, 95% CL 0.14 and 1.32). The infants of the study group in this subset also spent significantly less time in the neonatal wards (P = 0.029). To evaluate the impact of a large scale population screening programme on the birth incidence of Down's syndrome in the west of Scotland over a 12 month period.
                Biochemical screening for Down's syndrome using maternal serum alpha fetoprotein, chorionic gonadotrophin, and maternal age was offered to a pregnant population of 37,226 women in the west of Scotland between 1991 and 1992. The combined risk of Down's syndrome pregnancy was reported for each of the 30,084 women who opted for screening.
                When a threshold risk of 1:220 was used 1523 women (5.1% of the screened population) were assigned to the high risk group, of whom 1070 (70%) proceeded to diagnostic amniocentesis or midtrimester chorionic villus sampling. When multiple sources of ascertainment were used 37 Down's syndrome pregnancies were identified within the screened population, 26 (70%) of which were within the high risk group and 21 (57%) of which were prenatally diagnosed. In addition, three Down's syndrome pregnancies were diagnosed by first trimester chorionic villus sampling before biochemical screening. A further 10 Down's syndrome pregnancies were identified at birth, eight to women who had not had a screening test and two to women who had moved into the area, making a total of 50 Down's syndrome pregnancies in the whole pregnant population of 37,226. Thus the potential prenatal detection rate in the screened population was 70% (26/37), the actual prenatal detection rate in the screened population was 57% (21/37), and the overall prenatal detection rate in the total (screened and unscreened) population was 48% (24/50).
                Biochemical screening for Down's syndrome is practical and effective in routine clinical practice, enabling women to make an informed choice about prenatal diagnosis and providing better use of scarce resources when a suitable protocol is applied to the whole pregnant population. Its maximum potential for the reduction of the birth incidence of Down's syndrome is limited by incomplete uptake of screening and compliance with diagnostic testing in the high risk group. Infection with Trichomonas vaginalis during pregnancy has been associated with preterm delivery. It is uncertain whether treatment of asymptomatic trichomoniasis in pregnant women reduces the occurrence of preterm delivery.
                We screened pregnant women for trichomoniasis by culture of vaginal secretions. We randomly assigned 617 women with asymptomatic trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g doses of metronidazole (320 women) or placebo (297 women) 48 hours apart. We treated women again with the same two-dose regimen at 24 to 29 weeks of gestation. The primary outcome was delivery before 37 weeks of gestation.
                Between randomization and follow-up, trichomoniasis resolved in 249 of 269 women for whom follow-up cultures were available in the metronidazole group (92.6 percent) and 92 of 260 women with follow-up cultures in the placebo group (35.4 percent). Data on the time and characteristics of delivery were available for 315 women in the metronidazole group and 289 women in the placebo group. Delivery occurred before 37 weeks of gestation in 60 women in the metronidazole group (19.0 percent) and 31 women in the placebo group (10.7 percent) (relative risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004). The difference was attributable primarily to an increase in preterm delivery resulting from spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative risk, 3.0; 95 percent confidence interval, 1.5 to 5.9).
                Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended. North American cesarean delivery rates have risen dramatically since the 1960s, without concomitant improvements in perinatal or maternal health. A Cochrane Review concluded that continuous caregiver support during labor has many benefits, including reduced likelihood of cesarean delivery.
                To evaluate the effectiveness of nurses as providers of labor support in North American hospitals.
                Randomized controlled trial with prognostic stratification by center and parity. Women were enrolled during a 2-year period (May 1999 to May 2001) and followed up until 6 to 8 postpartum weeks.
                Thirteen US and Canadian hospitals with annual cesarean delivery rates of at least 15%.
                A total of 6915 women who had a live singleton fetus or twins, were 34 weeks' gestation or more, and were in established labor at randomization.
                Patients were randomly assigned to receive usual care (n = 3461) or continuous labor support by a specially trained nurse (n = 3454) during labor.
                The primary outcome measure was cesarean delivery rate. Other outcomes included intrapartum events and indicators of maternal and neonatal morbidity, both immediately after birth and in the first 6 to 8 postpartum weeks.
                Data were received for all 6915 women and their infants (n = 6949). The rates of cesarean delivery were almost identical in the 2 groups (12.5% in the continuous labor support group and 12.6% in the usual care group; P =.44). There were no significant differences in other maternal or neonatal events during labor, delivery, or the hospital stay. There were no significant differences in women's perceived control during childbirth or in depression, measured at 6 to 8 postpartum weeks. All comparisons of women's likes and dislikes, and their future preference for amount of nursing support, favored the continuous labor support group.
                In hospitals characterized by high rates of routine intrapartum interventions, continuous labor support by nurses does not affect the likelihood of cesarean delivery or other medical or psychosocial outcomes of labor and birth. The aim of the study was to determine the incidence of, and risk factors for, nevirapine (NVP)-associated hepatotoxicity and rash in HIV-infected Thai men and women, including pregnant women, receiving NVP-containing highly active antiretroviral therapy (HAART).
                NVP-containing HAART was prescribed to eligible men and women enrolled in the Prevention of Mother-To-Child Transmission of HIV (PMTCT) and MTCT-Plus programmes. All pregnant women received zidovudine (ZDV)/lamivudine (3TC)/NVP from >14 weeks of gestational age if their CD4 cell count was <or=200 cells/microL or from >28 weeks if their CD4 cell count was >200 cells/microL. Patients followed for at least 8 weeks after starting HAART or until delivery were included in the analyses.
                Of 409 patients, 244 were pregnant women, 87 were nonpregnant women and 78 were men. Hepatotoxicity occurred in 15.6% of all patients. Men had a significantly higher rate of asymptomatic hepatotoxicity (P=0.021). Pregnant women receiving HAART for PMTCT (92% had CD4 cell counts >250 cells/microL) had a significantly higher rate of symptomatic hepatotoxicity (P=0.0003) than pregnant women receiving HAART for therapy. Rash occurred in 16.1% of all patients. The patients' sex and baseline CD4 cell count were not associated with the risk of hepatotoxicity or rash. NVP was discontinued in 4.2% and 6.8% of patients because of hepatotoxicity and rash, respectively.
                The incidence of NVP-related hepatotoxicity and rash in Thai adults is similar to incidences reported for other populations. While larger studies are needed, our data support continued use of NVP-containing regimens as first-line treatment in developing countries for HIV-infected patients, including pregnant women. Pregnant women with high CD4 cell counts may experience higher rates of symptomatic hepatotoxicity and thus require careful clinical and laboratory monitoring. To estimate the effect of receiving HIV-positive test results on intentions to have future children and on contraceptive use and to assess the association between pregnancy intentions and pregnancy incidence among HIV-positive women in Malawi.
                Women of unknown HIV status completed a questionnaire about pregnancy intentions and contraceptive use and then received HIV voluntary counseling and testing (VCT). Women who were HIV-positive and not pregnant were enrolled and followed for 1 year while receiving HIV care and access to family planning (FP) services.
                Before receiving their HIV test results, 33% of women reported a desire to have future children; this declined to 15% 1 week later (P < 0.0001) and remained constant throughout follow-up. Contraceptive use increased from 38% before HIV testing to 52% 1 week later (P < 0.0001) and then decreased to 46% by 12 months. The pregnancy incidence among women not reporting a desire to have future children after VCT was less than half of the incidence among women reporting this desire.
                With knowledge of their HIV-positive status, women were less likely to desire future pregnancies. Pregnancy incidence was lower among women not desiring future children. Integration of VCT, FP, and HIV care could prevent mother-to-child HIV transmission.
Currently, there is insufficient evidence to recommend routine screening of asymptomatic or symptomatic pregnant women with TVU CL. Since there is a non-significant association between knowledge of TVU CL results and a lower incidence of PTB at less than 37 weeks in symptomatic women, we encourage further research. Future studies should look at specific populations separately (e.g., singleton versus twins; symptoms of PTL or no such symptoms), report on all pertinent maternal and perinatal outcomes, and include cost-effectiveness analyses. Most importantly, future studies should include a clear protocol for management of women based on TVU CL results, so that it can be easily evaluated and replicated.