A comparison of four methods of ripening the unfavourable cervix. A comparison of the efficacy and safety of extra-amniotic prostaglandin E2 and intravenous prostaglandin E2 for the induction of labour in patients with unripe cervices. Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Extra-amniotic prostaglandin E2 gel vs. amniotomy for elective induction of labour. Extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha for cervical ripening and induction of labor. Labor induction with vaginal misoprostol and extra-amniotic prostaglandin F2alpha gel. Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens. A randomized trial of extra-amniotic saline infusion plus intracervical Foley catheter balloon versus prostaglandin E2 vaginal gel for ripening the cervix and inducing labor in patients with unfavorable cervices. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Foley catheter under traction versus extra-amniotic prostaglandin gel in pre-treatment of unripe cervix--a randomised controlled trial. Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone.
A comparison was made between four methods of ripening the unfavourable cervix (extra-amniotic prostaglandin E2 gel, oral prostaglandin E2, intravaginal prostaglandin E2 and intravenous oxytocin) in a clinical trial involving 60 primigravidae. In all groups there was an improvement in cervical status. This was significantly greater in those patients who received extra-amniotic prostaglandin gel and they also showed significant decreases in the mean induction-delivery interval and in the incidence of Caesarean section. In a study comparing intravenous prostaglandin E2 (PGE2) with extra-amniotic PGE2 for the induction of labour, in patients with unfavourable induction features, we found no difference between the two methods in either safety or efficacy. However, we would not recommend the use of the extra-amninotic route as a routine method because of some technical difficulties. A new method for induction of labour--balloon catheter with extra-amniotic saline infusion (BCEAS)--is evaluated in randomised comparison with prostaglandin E2 (PGE2) in vaginal pessaries.
                One-hundred and nine pregnant women with unfavourable cervices.
                The efficiency of inducing vaginal delivery and the level of 'disadvantages following induction of labour' (DisFIL scorings).
                Overall, BCEAS was less efficient inducing vaginal delivery than vaginal PGE2 (P < 0.01) because of a significant difference among parous women (P < 0.01). In the (larger) primiparous women group, and particularly in the subgroup of these having very low pelvic scores (Lange score, < or = 3), the efficiencies of the two methods were equal (P = 0.06) and P = 0.55, respectively). The levels of DisFIL scorings were not significantly different. However, higher rates of caesarean section followed BCEAS than PGE2 (29% and 10%, respectively; P < 0.05). Serious infectious complications were not recorded following BCEAS. No difference was apparent in the status of the neonates (judging from Apgar scores and umbilical artery pH and SBE). The women, delivering vaginally, commented the two methods equally favourably.
                BCEAS was less efficacious than vaginal PGE2 pessaries, though among primiparous women, especially those with very unfavourable cervices, the difference was not significant. Further refinements of the method are suggested. A randomized study was performed to compare three methods of labour induction in 143 clinically normal women (43 nulliparas) at term: amniotomy with or without intravenous oxytocin, extra-amniotic prostaglandin (PG) E2 gel, and extra-amniotic PGE2 gel plus an indwelling catheter. The three methods appeared to be comparable in effect and all of them were perinatally safe. Thus, if preference is given to keeping the ovular sac intact during the early phase of induced labour, extra-amniotic PGE2 in viscous gel, either with or without an indwelling catheter,. can replace the classical induction technique. To compare the effectiveness of extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha for cervical ripening, induction of labor and achievement of vaginal delivery in patients with unfavorable cervices.
                A randomized trial of extra-amniotic saline infusion versus extra-amniotic prostaglandin F2alpha performed at Harare Central Hospital Maternity Unit, Zimbabwe. One hundred and sixty-four patients were recruited from those referred to Harare Central Hospital Maternity Unit who required induction of labor for either maternal or fetal indications.
                162 patients (extra-amniotic PgF2alpha group, N = 81; extra-amniotic saline infusion group, N = 81) had complete information. Two patients (one from each group) were lost to follow up. The demographic characteristics of the patients and the indications for induction were not statistically different. There was a marginally statistically significant difference in the change of Bishop Score in favor of the extra-amniotic saline infusion (4.0, S.D. = 1.4) as compared to (4.5, S.D. = 1.5) for extra-amniotic PgF2alpha (P value = 0.047). All other parameters showed no statistically significant differences. Maternal and fetal complications were minimal and not significantly different. Extra-amniotic saline infusion was however almost six times cheaper than PgF2alpha.
                Extra-amniotic saline infusion is as effective as PgF2alpha, safe, but much cheaper than PgF2alpha and should be seriously considered as a method of first choice in resource-poor settings. To compare the effectiveness of vaginally administered misoprostol with extra-amniotic prostaglandin F2alpha (PGF2alpha) gel for induction of labor.
                A randomized controlled trial, with women allocated to receive either misoprostol 50 microg intra-vaginally or extra-amniotic PGF2alpha gel 5 mg, was conducted in Harare Maternity Hospital. A total of 152 women were admitted for induction of labor with a term singleton, pregnancy and cephalic presentation were recruited. The main outcome was duration of induction.
                There were no differences in the characteristics of women in the two groups at recruitment. In the misoprostol group there was a significantly reduced need for augmentation of labor with oxytocin (OR=0.36; 95% C.I. 0.17-0.73) and delivery by cesarean section for failure to progress (OR=0.11; 95% C.I. 0.00-0.88). The risk for duration of induction to vaginal delivery exceeding 12, 18 or 24 h was reduced by 18%, 38% and 68%, respectively, but only the risk for duration >24 h was significantly reduced (OR=0.32; 95%C.I. 0.11-0.91). The mean duration of induction was shorter in the misoprostol group, 15.2 vs. 23.6 h (P=0.02). There were no differences in fetal outcome.
                Misoprostol 50 microg was associated with less use of oxytocin in labor, a shorter induction to delivery interval and fewer cesarean sections for failure to progress when compared with extra-amniotic PGF2alpha gel. To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities.
                A prospective randomised controlled trial.
                Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP.
                Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration.
                Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful.
                Proportion of successful inductions and complications.
                Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients).
                With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity. To compare the efficacy of extra-amniotic saline solution infusion plus an intracervical Foley catheter balloon versus 2.85 mg prostaglandin (PG) E2 vaginal gel in ripening the cervix, inducing labor, and achieving vaginal delivery in patients at term with an unfavorable cervix.
                A randomized study of the two methods was performed in 112 patients with a Bishop score of 5 or less.
                Extra-amniotic saline infusion plus intracervical Foley catheter balloon was more effective than PGE2 vaginal gel in causing cervical ripening (relative risk [RR] 2.5965, 95% confidence interval [CI] 1.7277-3.9022, exact two-tailed P = .000001) and in inducing labor (RR 4.3333, 95% CI 1.7223-10.9026, exact two-tailed P = .0000181). However, the final delivery outcome was an equally high number of cesarean deliveries (26 of 56, or 46.4%) for both methods. Maternal and neonatal complications were minimal and not significantly different.
                Extra-amniotic saline infusion with a Foley catheter was more effective than 2.85 mg PGE2 vaginal gel in ripening the cervix and inducing labor. These advantages did not translate into a large number of vaginal deliveries, indicating that factors other than cervical ripening may be responsible for the high incidence of cesarean in patients with an unfavorable cervix. To determine which of three methods of cervical ripening resulted in the lowest cesarean rate in women with unfavorable cervices and indications for labor induction.
                Consenting women with singleton gestations, vertex presentations, and unfavorable cervices (dilatation under 2 cm and effacement under 75%) were randomly assigned to laminaria and standard intravenous oxytocin, serial doses of intracervical prostaglandin (PG) E(2) gel (Prepidil, Pharmacia & Upjohn, Inc., Kalamazoo, MI) 0.5 microg every 6 hours for two doses followed by oxytocin if indicated, or extra-amniotic saline infusion and oxytocin.
                An interim analysis after recruitment of 321 subjects, 67% of the planned sample, found similar cesarean rates for the three groups (laminaria 36%; PGE(2) gel 33%; saline infusion 29%; P =.59); however, the mean randomization-to-delivery interval was significantly longer in the PGE(2) group. Stochastic curtailment, as part of the interim analysis, indicated a low likelihood of achieving a statistically significant difference in cesarean rates between PGE(2) gel and the other two groups. Therefore, we completed the study with saline infusion and laminaria. The saline infusion and laminaria groups had similar preinduction characteristics. The cesarean rates were similar (saline infusion 25.4% versus laminaria 30.3%; P =.32), but the mean interval from randomization to delivery was shorter in the saline infusion group (18.0 versus 21.5 hours, P =.002). There were no significant differences in selected maternal and neonatal morbidities.
                Cervical ripening with extra-amniotic saline infusion, PGE(2), or laminaria resulted in comparable cesarean rates in women with an unfavorable cervix and indications for labor induction. Extra-amniotic saline infusion had the shortest randomization-to-delivery interval without increasing maternal or neonatal morbidity. nan To compare three methods of labour induction.
                Randomised controlled trial.
                Academic hospitals in Johannesburg, South Africa.
                Women with intact membranes due for induction of labour.
                Randomised, sealed opaque envelopes were used to allocate women to labour induction with extra-amniotic Foley catheter/titrated oral misoprostol solution (N = 174), titrated oral misoprostol solution alone (N = 176), or vaginal dinoprostone (N = 176). Misoprostol was dissolved in water and 20-40 g was given 2-hourly.
                These were failure to deliver vaginally within 24 hours, additional measures for induction or augmentation of labour, analgesia, and maternal and fetal complications.
                In the Foley catheter group, misoprostol was required in all but 1 case. Failure to deliver vaginally within 24 hours was similar for the three groups (79/174 v. 70/176 v. 70/176 respectively). Labour augmentation, caesarean section and instrumental delivery were used somewhat more frequently in the Foley/misoprostol group than in the misoprostol alone group, but these differences were not statistically significant. More analgesia was used in the Foley catheter/misoprostol group than in the misoprostol group (64/172 v. 46/175). Side-effects and neonatal complications were similar for the three groups.
                Use of extra-amniotic Foley catheter placement showed no measurable benefits over the use of oral misoprostol alone, or vaginal dinoprostone.
The studies in this review are limited by sample size which are often divided into multiple comparison groups. Most comparisons showed no significant differences, with wide confidence intervals. Although extra-amniotic prostaglandins may be as effective as other modalities in initiating labour, there is little conclusive information from this review to guide clinical practice. An adequately powered randomised controlled trial would be useful to determine if the use of extra-amniotic prostaglandins would lower the rate of caesarean section.