Double-blind comparison of intracervical and intravaginal prostaglandin E2 for cervical ripening and induction of labor. Intravaginal versus intracervical application of prostaglandin E2 in viscous gel for cervical priming and induction of labor at term in patients with an unfavorable cervical state. Preinduction cervical ripening with prostaglandin E2 intracervical gel. Prelabour rupture of the membranes at term and unfavourable cervix; a randomized placebo-controlled trial on early intervention with intravaginal prostaglandin E2 gel. Intravenous oxytocin and oral prostaglandin E2 for ripening of the unfavourable cervix. Local administration of prostaglandin E2 for cervical ripening and labor induction: the appropriate route and dose. Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2: a randomized, double-blind, placebo-controlled trial. Intravaginal prostaglandin E2 for cervical ripening and initiation of labor. Comparison of a multidose gel and single, controlled-release pessary. Induction of labor by prostaglandin E(2) in relation to the Bishop score. Cervical ripening with intravaginal prostaglandin E2 gel. Preinduction cervical ripening: a randomized prospective comparison of the efficacy and safety of intravaginal and intracervical prostaglandin E2 gel. Double-blind comparison of intravaginal prostaglandin E2 gel and "chip" for preinduction cervical ripening. The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects. [Comparison between prostaglandin E2 gel and oxytocin in medically indicated labor induction]. Randomized, double-blind trial of prostaglandin E2 intravaginal gel versus low-dose oxytocin for cervical ripening before induction of labor. A randomized clinical trial of prostaglandin E2 intracervical gel and a slow release vaginal pessary for preinduction cervical ripening. Intravaginal misoprostol as a cervical ripening agent. A randomised controlled trial of an oral solution of prostaglandin E2 and oral oxytocin used immediately after low amniotomy for induction of labour in the presence of a favourable cervix. [Ripening of the cervix uteri at term by a single intracervical application of prostaglandin E2 gel]. Cervical ripening and labor outcome with preinduction intracervical prostaglandin E2 (Prepidil) gel. Cervical ripening and labor induction with intracervical triacetin base prostaglandin E2 gel: a placebo-controlled study. Uterine priming with oral prostaglandin E2 prior to elective induction with oxytocin. A comparison of four methods of ripening the unfavourable cervix. Pre-induction intracervical application of a highly viscous prostaglandin E2 gel in pregnant women with an unripe uterine cervix: a double-blind placebo-controlled trial. Induction of labor by prostaglandin E2: intracervical gel or vaginal pessaries? Randomized comparison of the effects of endocervical and vaginal prostaglandin E2 gel in women with various degrees of cervical ripeness. Dutch Collaborative Prostaglandin Trialists' Group. A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis. A comparison of prostaglandin E2 gel and prostaglandin F2 alpha gel for preinduction cervical ripening. Prostaglandin E2 cervical ripening without subsequent induction of labor. Open randomized comparison of prostaglandin E2 given by intracervical gel or vagitory for preinduction cervical ripening and induction of labor. A comparison of PGE2 and PGF2 alpha vaginal gel for ripening the cervix before induction of labour. A randomized trial of intracervical prostaglandin gel and intravenous oxytocin in prelabor rupture of membranes with unripe cervix at term. Induction of labor utilizing vaginal vs. intracervical prostaglandin E2. Preoperative administration of prostaglandin to avoid dilatation-induced damage in first-trimester pregnancy terminations. Endocervical prostaglandin E2 gel for preinduction cervical softening. Intracervical versus intravaginal PGE2 for induction of labor at term in patients with an unfavorable cervix. Outpatient cervical ripening with prostaglandin E2 gel in uncomplicated postdate pregnancies. Labor induction with intravaginal misoprostol versus intracervical prostaglandin E2 gel (Prepidil gel): randomized comparison. Intracervical prostaglandin in postdate pregnancy. A randomized trial. Cervical ripening with intravaginal prostaglandin E2 gel. Outpatient cervical ripening with prostaglandin E2 and estradiol. Randomized trial of intracervical prostaglandin E2 gel and intraamniotic prostaglandin F2 alpha for induction of second trimester abortion. Prostaglandin E2 for induction of labor in patients with premature rupture of membranes at term. [Induction of labor. Prostaglandin E2 vaginal tablets compared with intravenous oxytocin for induction of labor in premature rupture of the membranes and immature cervix]. Cervical ripening before medical induction of labor: a comparison of prostaglandin E2, estradiol, and oxytocin.
Our purpose was to compare the safety and effectiveness of prostaglandin E2 delivered sequentially as an intracervical (0.5 mg) or intravaginal (2.5 mg) gel.
                Hospitalized patients with an unfavorable cervix (Bishop score < or = 4) at > or = 35 weeks and requiring induction of labor were assigned to receive two 2.5 ml doses of gel intracervically and intravaginally in a double-blind, placebo-controlled manner. Second and third doses were given at 6-hour intervals until there were either regular uterine contractions or a Bishop score change > 3 points.
                The 100 evaluable cases received prostaglandin E2 either intracervically (n = 52) or intravaginally (n = 48). Difficulty with exact gel instillation was present with intracervical gel only, where spillage occurred in 85% of cases. Compared with intracervical therapy prostaglandin E2 given intravaginally was more likely to significantly change the Bishop score (60.4% vs 40.4%, p = 0.04) and stimulate regular contractions (72.9% vs 48.1%, p = 0.01). Uterine hyperstimulation was present in one case in each group.
                Although each was safe, instillation of prostaglandin E2 gel was better at a higher intravaginal dose than a lower intracervical dose because of its greater ease of administration and higher likelihood of cervical change. Sixty term pregnant women with unripe cervix were randomly given either 0.5 mg of prostaglandin E2 (PGE2) in 2 ml of gel intracervically or 4 mg of PGE2 in 3 ml of gel intravaginally to prime the cervix and/or to induce labor. In patients with a highly unfavorable cervix (cervical score less than or equal to 3), the intracervical application was significantly more effective than the intravaginal. In patients with a more favorable cervical state (cervical score 4 or 5), the two routes of application were equipotent. Gastrointestinal side effects were registered after intravaginal but not after intracervical application. Myometrial activity was significantly more increased after intravaginal than after intracervical gel application. All children were born in good condition with an Apgar score greater than 7 within 5 minutes. A double-blind, placebo-controlled, dose-ranging study was undertaken to evaluate the efficacy of two doses of intracervical prostaglandin E2 gel in patients with unfavorable Bishop scores. Mean change in Bishop score, success of softening, time to labor, and time to delivery were all significantly different in the two treatment groups as compared with the placebo group. Twenty-three of 30 treated patients had uterine contractions lasting greater than four hours and eight patients delivered during the observation period. Moreover, one case of uterine hyperactivity and five cases of severe fetal heart rate decelerations were noted in the treatment groups. Although efficacious for cervical ripening, caution is warranted when using this technique in patients at risk for placental insufficiency. Fifty nine women with prelabour rupture of membranes, unfavourable cervix and no evidence of infection or fetal distress were randomized formally to receive prostaglandin E2 (3mg) gel or sterile K-Y Jelly intravaginally. Conservative expectant management was followed for the next 24 hours. The subsequent management of the labour followed departmental protocol. The women who received prostaglandin went into labour sooner and were delivered earlier but the duration of labour was not significantly different. There were no significant differences in other clinical outcomes. There was 1 case of uterine rupture in the prostaglandin group. We conclude that early intervention with prostaglandin E2 gel intravaginally confers no advantage compared with conservative management except for earlier confinement in this group of patients. A clinical trial involving 60 patients was conducted to assess the relative efficacy of intravenous oxytocin and oral prostaglandin E2 in ripening the unfavourable cervix, when given as a priming dose on the day before induction of labour. There was significant improvement in the Bishop score, and the subsequent induction-delivery interval following priming with prostaglandin. This improvement appeared to be dose-related. Although there are many comparative studies concerning the local administration of prostaglandin E2 gel for cervical ripening and labor induction, the safety, efficacy and the appropriate route and dose of the gel are still debated.
                One hundred and ten women with high-risk pregnancy and unripe cervix received prostaglandin E2 gel 1 mg intravaginally (n=35), 2 mg intravaginally (n=36) and 0.5 mg intracervically (n=39), maximally three times at 6-hour intervals for cervical ripening prior to labor induction. The safety, efficacy and optimal dose were assessed.
                The 2 mg intravaginal gel and the 0.5 mg intracervical gel were equally effective and more effective than the 1 mg intravaginal gel in labor characteristics such as ripening time and cesarean section rate, but not in labor time. However, the failure rate (labor could not be induced) was highest in the intracervical group (10.3%) compared to the intravaginal groups (2.9% and 2.8%), although the differences were not statistically significant. In the two intravaginal groups three and five patients received the third gel application and one patient in both groups could not be induced. In the intracervical group the ripening of the cervix failed in all patients, who received the third gel. The neonatal outcome was uneventful in all groups. There were two cases of uterine hypertonus associated with fetal bradycardia, one in the intracervical and one in the 2 mg intravaginal group. Thus careful fetal monitoring is necessary. Furthermore, the vaginal route has the advantage of an easier technique of administration and obviously lower risk for inadvertent extraamnial instillation.
                We recommend the use of multiple applications of 2 mg intravaginal prostaglandin E2 gel as a safe, effective and easy method for preinduction cervical ripening in high-risk pregnancies. More than three gel applications hardly increase the efficacy. Our purpose was to determine whether a protocol for outpatient induction is safe and effective for initiating labor.
                A randomized, double-blind, placebo-controlled trial was performed with 100 low-risk patients having well-dated pregnancies. Women with a Bishop score < or = 6 at 38 to 40 weeks' gestation were administered either 2 mg of intravaginal prostaglandin E2 gel or placebo for 5 consecutive days as outpatients while undergoing fetal monitoring.
                The median interval from randomization to delivery was 4 days in the prostaglandin E2 group (range 0 to 28 days) versus 10 days in the placebo group (range 0 to 26 days, p = 0.002). Twenty-seven of 50 patients (54%) in the prostaglandin E2 group were admitted for labor during the dosing interval compared with 10 placebo-treated patients (20%, p = 0.001). The mean gestational age at delivery was significantly reduced in the treatment group (39.9 +/- 1.0 weeks vs 40.5 +/- 0.99 weeks, p = 0.003) as was the incidence of postdates pregnancy (40% vs 66%, p = 0.016). Hyperstimulation was observed in one prostaglandin E2-treated patient, but no intervention was required.
                Outpatient low-dose prostaglandin E2 gel administration is effective for initiating labor in patients with an unfavorable cervix and appears safe if performed with adequate monitoring. A study was conducted to compare the efficacy and safety of two methods of delivering prostaglandin E2 (PGE2) as a low-dose gel delivered in up to two sequential, 2.5-mg doses and as a single-dose, controlled-release, 10-mg pessary. A cervical change was present in both groups, but a Bishop score > or = 8 occurred in more nulliparous patients in the pessary than in the gel group by 12 hours after dosing. Labor was initiated without oxytocin more frequently in the pessary than gel group for nulliparas and multiparas. Reversal of uterine hyperstimulation was possible by removal of the pessary without tocolytic therapy. The controlled-release PGE2 pessary was more effective in changing the cervix in nulliparas and in initiating labor and offered the advantage of removal when desired. To compare the effectiveness of prostaglandin E(2) intravaginal gel with the intracervical gel in patients with an unfavorable cervix.
                In a prospective multicenter trial 470 patients with unfavorable Bishop scores (3-4) were randomized to receive prostaglandin vaginal gel (2 mg) or intracervical gel (0.5 mg).
                In patients with unfavorable Bishop scores the intravaginal application route resulted in a better cervical ripening, a shorter induction to delivery interval and a higher cumulative rate of deliveries during 24 h (P=0.01).
                Intravaginal instillation of prostaglandin E(2) gel for induction of labor is effective in patients with an unfavorable Bishop score of 3-4. Fifty-four patients were randomized in a double blind fashion into either a placebo group or a group treated with a 3 mg dose of an intravaginal prostaglandin E2 gel. The group receiving the prostaglandin E2 gel had a mean change in cervical score of 2.7 while the patients in the placebo group had no significant change. Even though a significantly higher number of patients in the prostaglandin group went into spontaneous labor, the incidence of cesarean section was not different between the two groups. Upon comparing the conflicting reports of various studies on the subject, it is concluded that the method of product preparation, particularly the source of prostaglandin E2 utilized and the choice of drug vehicle, may be important variables in determining treatment success, as measured in terms of decreased cesarean section rate. The purpose of this study was to compare the effectiveness and safety of vaginally administered 5 mg prostaglandin E2 gel prepared in our hospital pharmacy with a commercially available 0.5 mg intracervical prostaglandin E2 gel.
                Eighty-three patients undergoing labor induction were randomly assigned to one of two groups for cervical ripening. Either a preparation of 5 mg of prostaglandin E2 was placed vaginally or a commercially available 0.5 mg of prostaglandin E2 was placed intracervically. A maximum of three doses at 6-hour intervals was administered before oxytocin was begun.
                Among the 83 patients evaluated, 44 were given vaginal gel and 39 were given intracervical gel. No statistically significant differences were observed between the two treatment groups with respect to the incidence of spontaneous versus induced labor, need for oxytocin augmentation, gel-to-induction interval, Bishop score change, maximum oxytocin dose, maximum dilatation rate, length of labor, cesarean section rate, fetal Apgar scores, fetal umbilical vein pH, or fetal umbilical artery pH.
                The two prostaglandin E2 formulations appear equivalent in efficacy and safety. Constraints placed on intracervical prostaglandin E2 gel make the vaginal preparation a desirable choice. The intravaginal application of prostaglandin E2 for preinduction cervical ripening has proved to be advantageous in the management of patients with an unfavorable cervix. The purpose of this double-blind randomized investigation was to compare the efficacy and safety of two methods of prostaglandin E2 delivery. Patients who were to have preinduction cervical ripening because of an unfavorable cervix (Bishop score less than or equal to 4) were randomly assigned to be given a single dose of prostaglandin E2 as either 2.5 mg of gel or a 3.0 mg "chip" intravaginally in a placebo-controlled manner. Sixty-nine patients received the active prostaglandin E2, 34 in the gel group and 35 in the "chip" group. The groups were similar in maternal age, race, parity, gestational age, and initial Bishop score. Both forms of prostaglandin E2 were easy to administer and helpful in priming an unfavorable cervix. The need for, duration of, and maximum dose of oxytocin were similar in both groups. Cesarean delivery because of failed induction occurred in 5 of 35 (14.3%) patients receiving a "chip" and 4 of 34 (11.8%) receiving the gel. However, patients receiving a "chip" experienced a 20% (7/35) incidence of hyperstimulation, compared with 2.9% (1/36) in those receiving the gel (p less than 0.05). The only case requiring immediate cesarean delivery because of intractable uterine hyperstimulation received a "chip." We conclude that both methods were effective for cervical ripening, but the lower incidence of uterine hyperstimulation seen with the gel would suggest that it is preferable to the "chip." Two different applications of prostaglandin E2 for induction of labor were randomly used in 113 women with an unripe cervix; 57 women were given prostaglandin suppositories each containing 2.5 mg PGE2 in a basis of Witepsol S55 (Dynamit Nobel), another 56 women were treated with intracervical gel containing 1 mg PGE2 in 5 g hydroxypropylmethyl cellulose. The treatment was repeated after 4 h if the cervix was still unripe, and the procedure was repeated the following day if the cervix was still unfavorable. Cesarean sections was performed within 48 h after the start of induction and before the second stage of labor in 8 women in the suppository group and 7 women in the intracervical gel group. Of the remaining 98 women, 73% (34/48 women) in the suppository group and 36% (18/50 women) in the cervical gel group had delivered within 24 h (p less than 0.01). After 48 h, 88% (42/48 women) in the suppository group and 74% of the women (37/50 women) in the cervical gel group had delivered (p greater than 0.05). The induction-delivery interval in the suppository group was half that found in the cervical gel group. There was no significant difference between the two groups in the use of instrumental vaginal deliveries and cesarean sections nor was there any difference with regard to fetal distress. The post-delivery condition of the newborn was similar in the two groups. No side-effects were reported in either of the two groups. The use of prostaglandins (PG) increasingly replaces the "classical" method of induction of labour by means of oxytocin and amniotomy, the last-named method being associated, especially in women with an unripe cervix, with side effects like prolonged labour and a higher rate of obstetric surgery. In this study the point of interest was whether prostaglandins offer any advantages over the classical method in respect of efficacy and maternal and foetal tolerance. 99 patients subdivided into primiparae and multiparae were randomly assigned to group A or B. In group A labour was induced with 1 mg resp. 2 mg PGE2 intravaginally at an interval of 6 hours. In group B the method of induction consisted of intravenous oxytocin and amniotomy. The success rate of induction was almost equal in both groups. However, in those patients where PGE2 induction did not succeed and who could not be delivered within 12 hours the cervical score was significantly improved in comparison to the oxytocin group. Based on the experience reported in the literature, one might speculate that an increased dosage could still improve the results of vaginally administered PGE2 gel. Our purpose was to compare two methods of preinduction cervical ripening in a randomized, double-blind clinical trial.
                Two intravaginal, 4 mg prostaglandin E2 gel applications administered 4 hours apart were compared with 10 hours of low-dose oxytocin (2 mU/min) in 200 patients undergoing preinduction cervical ripening.
                There were no differences in parity, initial Bishop scores, estimated gestational ages, indications for induction, or birth weights. Prostaglandin E2 gel was significantly better (p < 0.0001) at achieving a change in the Bishop score of 3 or more. The number of successful inductions was significantly greater (p < 0.0003) and the mean time to active labor was significantly shorter (p < 0.0002) in the prostaglandin E2 group than in the oxytocin group. More multiple-day inductions (p < 0.01) occurred in the oxytocin group, and fewer discharged patients who did not deliver infants (p < 0.03) were seen in the prostaglandin E2 gel group. There were no differences between patient groups in the cesarean section rate, meconium staining, hyperstimulation, and Apgar scores.
                Two 4 mg doses of prostaglandin E2 intravaginal gel applied 4 hours apart are superior to low-dose oxytocin in producing cervical ripening and preparing for successful induction. Our purpose was to compare the efficacy of 2 different prostaglandin E2 delivery methods for preinduction cervical ripening.
                Ninety patients admitted for labor induction with a Bishop score <8 were randomized to either 0.5 mg prostaglandin E2 intracervical gel (Prepidil) every 6 hours for 2 doses or 10 mg prostaglandin E2 slow release vaginal pessary (Cervidil). Oxytocin induction was begun after 12 hours. It was estimated that enrollment of 90 women would be required to identify a 30% difference in the percent delivered in <24 hours (1 - beta = .80, alpha = .05). Data were analyzed with use of chi2 analysis or the Student t test.
                There were 45 subjects in each treatment arm. The percent delivered by 24 hours was 53% with intracervical gel and 63% with vaginal pessary (P = .28). Mean change in Bishop score was 1.8 +/- 1.9 for the intracervical gel versus 3.2 +/- 3.1 for the vaginal pessary (P = .01). No difference was demonstrated in mean time to delivery, 28.3 versus 24.0 hours (P = .19) or percent requiring cesarean section.
                Preinduction cervical ripening with a slow release prostaglandin E2 vaginal pessary resulted in greater change in Bishop score than with intracervical prostaglandin E2. There was a trend toward shorter time to delivery with the pessary. There was no statistically significant difference in percent delivered in <24 hours. To determine if misoprostol (exogenous prostaglandin E1 PGE1) used vaginally was of value in improving the Bishop score, leading to an early safe vaginal delivery in women in whom the cervix is unripe and delivery is indicated.
                A double-blind clinical trial.
                Antenatal and labour wards of the University Hospital of the West Indies, Jamaica.
                Forty-five women in the third trimester with various obstetric indications for induction of labour and with no contra-indications to prostaglandins.
                The women were randomly assigned to receive treatment or a placebo. The treated group had 100 micrograms misoprostol inserted vaginally while the placebo was similarly inserted.
                Efficacy of the misoprostol was measured by the increase in the Bishop score 12 h after giving the treatment, the time between insertion and delivery, the need for oxytocin, and the outcome of the pregnancy.
                The prostaglandin was superior to the placebo in ripening the cervix and inducing labour. The change in Bishop score was 5.3 in the misoprostol group compared with 1.5 in the placebo group (P < 0.001). The mean time from insertion to delivery was 15.6 h in the former while it was 43.2 h in the placebo group (P < or = 0.001). The need for oxytocin was also significantly less in the women receiving the prostaglandin compared with those who received the placebo (29% vs 62%, P < 0.02). There was no difference in the two groups in the delivery outcome in terms of complications, Apgar scores and mode of delivery.
                Intravaginal misoprostol is an effective and cheap method of inducing labour in the third trimester. A randomised controlled trial was carried out in 50 primigravidae and 50 multigravidae to compare the effectiveness in induction of labour after low amniotomy of prostaglandin E2, given as an oral solution, and oxytocin, given as buccal tablets. The results showed that in dosages recommended by the manufacturers, both oxytocic preparations were almost equally effective. With oral oxytocin, once labour had been established and dosage was left to the discretion of the staff, there appeared to be a potentially dangerous tendency to continue giving large doses despite adequate uterine contractions. The authors comment that this was probably the reason why oxytocin-treated multigravidae having normal deliveries within 24 hours had labours significantly shorter on average than those of other successfully induced patients. The efficacy and the side effects of an intracervical PGE2 gel application, as compared to placebo, for priming of the cervix have been studied in 208 patients at term (104 PGE2 and 104 placebo) with an unripe cervix (Bishop score less than 5) and with a medical indication for induction of labour. The cervical ripening success rate (as defined in methodology) is significantly higher in the treated group (58.6%) than in the control group (27.8%; p = 0.0001): 38.5% out of the PGE2 treated patients delivered within 12 hours after the gel application; 12 hours after PGE2 or placebo gel application labour was induced in the remaining patients with intravenous oxytocin infusion. Under these conditions there were 13.5% failures in the PGE2 treated group and 16.3% in the placebo group. We observed a statistically significant decrease in the length of labour of the PGE2 treated patients as compared to the control group. Since signs of myometrial hypercontractility were observed in the PGE2 treated group as compared to the control group (p = 0.01), the authors advocate careful cardiotocographic monitoring for at least three hours after the gel application. It is concluded that intracervical application of Prostaglandin E2 followed by intravenous infusion of oxytocin in an effective and safe method for induction of labour with an unfavorable cervix at term. Delivery with an unfavorable cervix using oxytocin is frequently unsuccessful. Used widely in Europe and increasingly in this country, locally applied prostaglandin E2 appears to improve labor induction. The present study prospectively evaluated the efficacy and safety of a prostaglandin gel (0.5 mg) placed intracervically. The use of the gel, when compared to a control group who received no pretreatment prior to labor induction, resulted in improved Bishop scores (7.5 +/- 1.0 vs. 1.8 +/- 0.3, P less than 0.0001), reduced induction to delivery intervals (10.1 +/- 2.1 vs. 20.6 +/- 2.0 hours), reduced oxytocin infusion duration (10.0 +/- 2.1 vs. 20.0 +/- 2.3 hours. P less than 0.0001) resulting in a lower cesarean delivery rate, 26 vs. 47 per cent (P greater than 0.05). Thirty-two per cent of patients receiving the prostaglandin gel labored and delivered within 12 hours and required no oxytocin. In addition, the use of prostaglandin E2 gel appeared safe in that no patient experienced an untoward reaction. Two cases of uterine hyperstimulation occurred that required uterine tocolysis but were not associated with fetal distress. The use of prostaglandin gel appears to be a safe and effective method to improve cervical inducibility in patients undergoing induction for a variety of maternal and fetal indications. A double-blind, randomized, placebo-controlled study was undertaken to evaluate the efficacy of a single-dose, shelf-stable preparation of prostaglandin E2 gel (PGE2) when used intracervically in patients with low Bishop scores. Two different preparations (0.5 and 0.25 mg) of PGE2 were used and a total of 45 patients were studied. Both preparations of PGE2 demonstrated a statistically significant increase in the spontaneous labor rate as compared with the placebo gel. Bishop scores were altered in all patients not proceeding to labor spontaneously, but the changes were most significant in the low- and high-dose groups. No significant deleterious affects were noted. The efficacy and safety of this new, sterile, and stable preparation makes it suitable for clinical use. Fifty pregnant women at term, with a cervix unfavorable for induction, were electively induced with intravenous oxytocin after priming with either oral prostaglandin E2 or a placebo. Oral PGE2 was effective in increasing the Bishop score and in inducing labor prior to the induction, but did not increase the incidence of successful inductions. 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. Intracervical application of prostaglandin E2 (PGE2) gel has shown to be an effective method for pre-induction cervical ripening in pregnant women with an unripe uterine cervix. Side effects are minimal, provided that the instillation is carefully restricted to the cervical canal. This requires--apart from a proper technique--an optimal gel formulation. For this reason a newly developed highly viscous PGE2 gel was evaluated in a randomized, double-blind, placebo-controlled multicentre trial. Within a 9-h study period, successful cervical ripening (increase in Bishop score to 6 or more) was achieved in 39 (56%) of the 70 patients in the PGE2 groups and in 23 (34%) of the 68% patients in the placebo group (P = 0.04). During the first 12 h after gel application, 25 (35%) of the women in the PGE2 group and 2 (3%) in the placebo group had a spontaneous delivery. No serious adverse reactions were observed. The data suggest that the use of this highly viscous PGE2 gel may be advantageous if strictly intracervical application is the primary objective. To investigate the best route of prostaglandin medication for induction of labor, 125 pregnant women with unfavorable cervices (Bishop scores less than or equal to 6) were randomized to induction of labor with either PGE2 (0.5 mg) in a viscous intracervical gel once daily or PGE2 pessaries (2.5 mg) 1-2 a day. As estimated by life table analysis, the pessaries were significantly more effective inducing vaginal delivery compared to intracervical gel (24 h: P less than 0.025, 48 h: P less than 0.01, logrank test) and vaginal delivery was obtained within 24 h/48 h in 50%/72% of the women in the pessary group and in 29%/55% of the women in the intracervical group. Cervical ripening was found within 3 h (P less than 0.001) and in the subsequent 3 to 24 h period (P less than 0.005) after both treatments, no difference being found between the groups. The pessaries were much more effective inducing regular contractions compared to the intracervical gel (P less than 0.005, logrank test), so the latter seems preferable if cervical ripening rather than induction is intended. No difference was found analyzing the active labor period. No difference was found in methods of delivery, neonatal parameters (Apgar scores, umbilical artery blood pH and standard base excess), and the patients' attitude towards both methods of induction were equally favorable. The trail was conducted to obtain an unbiased comparison of the relative merits of endocervical and vaginal prostaglandin E2 gel in a weighted case mix of parous and nulliparous women with favorable and unfavorable cervical features.
                Multicenter randomized trial with 285 participants, (three exclusions) was performed with sealed envelopes stratified for parity and Bishop score.
                Outcomes of labor and delivery were clearly related to the cervical score at trial entry, especially in nulliparous women. Endocervical prostaglandin E2 had a more marked effect on cervical ripeness than did vaginal prostaglandin E2, but this did not result in any differences in more substantive outcomes. Frequencies of delivery within 12 (50%) and 24 hours (77.7%), cesarean section (7.3%), instrumental vaginal delivery (11.7%), and poor infant outcomes were similar with both preparations.
                Because differences in effectiveness between endocervical and vaginal prostaglandin E2 in triacetin gel are marginal, preferences of women and clinicians can determine the choice between them. The ability of prostaglandin E2 to prepare the unripe cervix before an indicated labor induction is controversial. We therefore tested 100 pregnant women in a randomized, double-blind trial with intracervical prostaglandin E2 gel, 0.5 mg. The 53 women who received the placebo gel had an outcome similar to that of the 47 women who received the prostaglandin E2 gel. The mean change in cervical score, mean application-to-delivery interval, incidence of uncomplicated spontaneous labor, incidence of cesarean delivery for a failed induction, and the overall cesarean section rate were not significantly different for the two groups. A meta-analysis, incorporating 18 studies of 1811 patients who received a single application of at least 5 mg prostaglandin E2 gel intravaginally or 0.5 mg intracervically, demonstrated no significant decrease in the overall cesarean delivery rate (p = 0.85). We conclude that the use of single-dose intracervical prostaglandin E2 gel for cervical ripening has little effect on labor induction. Moreover, the use of single-dose intracervical or intravaginal prostaglandin E2 gel does not alter the incidence of cesarean delivery, even when large numbers of patients are analyzed by combining the results of similar reports. The unfavorable cervix remains a major obstacle to the successful induction of labor. Reported are results from an ongoing study of topical prostaglandin preparations used to effect preinduction cervical ripening. The current study compares the efficacy of 40 mg of prostaglandin (PG) F2 alpha versus 5 mg of PGE2, applied to the cervix in a methyltylose gel the night before attempted induction of labor. A prospective double-blind protocol was used similar to that which previously established the efficacy of the 5 mg of PGE2 preparation versus placebo at this institution. Results indicate the superiority of the PGE2 preparation as measured by change in Bishop score, Pitocin requirement, rate of cervical dilatation, and percentage of failed inductions. Cesarean section rates were similar in the two study groups, and no fetal or maternal morbidity was attributable to the preinduction ripening technique. To determine whether outpatient administration of intracervical prostaglandin (PG) E2 gel decreases the interval to delivery and duration of labor.
                A randomized, double-blind, placebo-controlled trial compared the intracervical placement of 0.5 mg PGE2 gel with placebo in 61 pregnant women at 38 weeks' or greater gestation with Bishop scores less than 9. Transvaginal cervical length, fetal fibronectin, and Bishop score were assessed before gel placement. Subjects were then allowed to go into spontaneous labor unless an indication for induction developed.
                Thirty women were assigned to PGE2 and 31 to placebo. There were no significant demographic differences between the groups and there were no differences in cervical length, fetal fibronectin status, or Bishop scores. Fifteen women in the PGE2 group and five in the placebo group went into labor and delivered within the first 2 days after gel placement (P = .007). The median interval to delivery was significantly shorter in the PGE2 group, at 2.5 days, compared with placebo, at 7 days (P = .02). Nulliparas in the PGE2 group had a median interval to delivery of 2 days, compared with 7 days for nulliparas receiving placebo (P = .03). Active phases of labor were significantly shorter in the PGE2 group and for women with a negative fetal fibronectin test who received PGE2.
                Outpatient administration of intracervical PGE2 gel shortened intervals to delivery and shortened labor. Intracervical application of prostaglandin E2 (PGE2) in a viscous gel was compared with conventional wax-based PGE2 vagitories (pessaries) for ripening of the cervix prior to induction of labor. A total of 226 healthy pregnant women at term were randomly allocated to receive intracervical gel with an effective dose of 0.5 mg (n = 116) or vagitories containing 2.5 mg PGE2 (n = 110). All women had a modified cervical score of less than or equal to 4. The numbers of cases contributed by each of the three centers were similar. There was no significant difference in parity, gestational length, maternal characteristics, indications for induction or preinduction cervical scores between the treatment groups. The rate of spontaneous birth was 71% in the gel group, compared with 69% in the vagitory group. Successful treatment was defined as active labor within 24 h or a change in cervical dilatation allowing artificial rupture of the membranes with subsequent progressive labor. The success rate was not significantly different in the gel group (82%) compared with the vagitory group (80%). There were no differences in the frequency of fetal distress, outcome of labor, assisted delivery rates or maternal side effects. The cervical scores were not different at 12 and 24 h after application. Intracervical gel and intravaginal application of PGE2 were similar in their efficacy and safety for ripening of the cervix and inducing labor at term. The efficacy of a vaginal gel containing either 5 mg prostaglandin E2 (PGE2) or 25 mg prostaglandin F2 alpha (PGF2 alpha) to ripen the unfavourable cervix for labour induction was assessed in a double blind trial. PGF2 alpha, compared with PGE2, had little effect upon the clinical state of the cervix, but the resultant duration of labour in each of the two groups was shorter than in a control group. While the numbers of patients requiring oxytocin stimulation of labour and regional analgesia were reduced in both groups compared with the controls, PGF2 alpha was much less effective than PGE2. Uterine hypertonus was observed using both prostaglandins during an experimental study and the implications are discussed. In order to compare the efficacy of immediate intravenous oxytocin administration and intracervical prostaglandin E2 gel application in premature rupture of membranes with unfavorable cervices at term, 45 term pregnant patients with premature rupture of membranes were randomized into two groups. Twenty women received immediate intravenous oxytocin after cleansing enema while the rest were treated with intracervical prostaglandin E2 gel. Means of maternal age, gestational age, Bishop score at admission and the rates of nulliparity did not show any significant differences between the two groups (p > 0.05). The mean rupture to delivery time was 12.6 +/- 4.4 hours in the oxytocin group and 16.5 +/- 4.5 hours in the prostaglandin group (p < 0.01). Mean birth weights and Apgar scores were insignificant. Cesarean section rates were 24% in the oxytocin group and 5% in the other (p < 0.05). No infectious morbidity was seen in any case. In conclusion, although delivery is delayed with the intracervical prostaglandin approach, cesarean section rate is lowered without an increase in infectious morbidity. To compare the efficacy of intracervical vs. vaginal prostaglandin E2 (PGE2) gel for induction of labor.
                Sixty-eight women scheduled for elective induction of labor at term were randomized to receive either 0.5 mg intracervical PGE2 (I/C group, n = 37) or 2 mg vaginal PGE2 gel (Vag group, n = 31) on a 6-hourly basis for a maximum of three doses.
                Three participants who delivered by cesarean section soon after gel administration were excluded from further analysis. Twenty-nine of 30 (97%) in the Vag group were successfully induced compared with 23 of 35 (66%) in the I/C group (P < 0.01). The induction-active labor intervals were 8.0 +/- 5.4 h for the Vag group and 23.1 +/- 27.6 h for the I/C group (P = 0.002). The induction-delivery intervals were 12.4 +/- 6.3 h for the Vag group and 29.8 +/- 29.1 h for the I/C group (P = 0.001). Uterine hyperstimulation and perinatal outcome were similar in both groups.
                Vaginal PGE2 was more efficacious than intracervical PGE2 in inducing labor. A prospective, randomized, controlled study was carried out to investigate the dilating and softening effect on the cervix of prostaglandin F2-alpha gel administered intracervically and of prostaglandin E2 tablets administered orally. A total of 581 patients were included in the study: 149 received 2.5 mg prostaglandin F2-alpha in gel form intracervically, 150 received 1 mg prostaglandin E2 in tablet form orally, 138 were given placebo gel and 144 no medication at all. In the group given prostaglandin F2-alpha gel intracervically, success was achieved in 85.8% of patients and partial success in 8.8%. In the group given prostaglandin E2 tablets orally, the results were successful in 29.4% and partially successful in 40.6%. The incidence of side effects in the group given prostaglandin F2-alpha gel was rather high - 53%. The results show that prostaglandin can bring about a certain softening of the cervix, but side effects cannot be ruled out. Nevertheless, priming of the cervix is to be recommended in young primigravidas. A single, endocervical application of a new commercial preparation of prostaglandin E2 (PGE2) gel, 0.5 mg of PGE2 in 2.5 ml (3 g), was evaluated for preinduction cervical softening. Safety and efficacy were assessed in a comparison with a 2.0 mg PGE2 vaginal tablet and placebo in normal nulliparous women at term, with low Bishop scores. Treatment was administered in randomized, double blind fashion. Overall success, defined as a progression in Bishop score of at least 3 points within 12 hours, was achieved in 22/40 (55%) of the gel group, 15/41 (37%) in the tablet treated women, and 8/40 (20%) in those receiving placebo. Of interest was the observation that of women with very unfavorable induction features (Bishop score 0-2), the cervical gel treatment resulted in a 6/8 (75%) success rate compared with 2/13 (15%) success for the vaginal tablet and 0/17 (0%) for placebo. In as much as a very low incidence of side effects accompanied this treatment scheme, expanded multi-center testing is recommended. In a randomized double-blind study we evaluated the effects on cervical ripening and labor induction of 0.5 mg PGE2 in gel given intracervically and 2.0 mg PGE2 given as a vaginal suppository. All patients were at term with unfavorable cervical scores. The indications for induction were toxemia, diabetes mellitus, Rh-immunization, or intrauterine growth retardation. Significantly better results for both cervical priming and labor induction were obtained after intracervical PGE2-gel application than after treatment with placebo or vaginal suppositories. Eleven out of 19 patients (58%) were delivered within 24 h after intracervical PGE2-gel compared to two out of 19 patients given placebo (p less than 0.01). In patients not delivered 24 h after the start of treatment, the mean cervical score had changed from 3.7 to 6.0 (p less than 0.05) after PGE2-gel application compared to a change from 3.9 to 4.3 after placebo treatment (n.s.). The outcome after treatment with PGE2 suppositories did not differ significantly from that with placebo treatment. In a subsequent study 25 patients were given 0.5 mg PGE2-gel intracervically. The results were consistent with those obtained in patients receiving PGE2-gel intracervically in the double-blind study. Few side effects were noted. No patient complained of gastro-intestinal discomfort but increased myometrial activity was observed in two patients; one after placebo and the other after active intracervical PGE2-gel treatment. The hyperactivity was readily countered with the beta 2-agonist, terbutaline. All infants were born in good condition with Apgar scores of 7 or more within 5 min. At pediatric examinations at 1 week and at 6 months of age all children seemed healthy. A double-blind, placebo-controlled, prospective investigation was undertaken to determine whether the outpatient administration of prostaglandin E2 gel was helpful for ripening the cervix in postdate pregnancies. One hundred eighteen women with an uncomplicated pregnancy at or beyond 42 weeks' gestation with an unripe cervix (Bishop score less than or equal to 5) were randomly administered a single dose of gel containing either 2.5 mg prostaglandin E2 (n = 55) or a placebo (n = 63) before induction of labor with Pitocin. No side effects were detected in these healthy mothers and fetuses. A distinct change in Bishop score after 12 hours occurred more often in the prostaglandin E2 than in the placebo group (42% versus 6%, p less than 0.0001). Forty-four women (80%) who had received prostaglandin E2 were admitted in early labor; they required little or no oxytocin for augmentation. The duration of labor and maximum dose of oxytocin infused were significantly decreased in the prostaglandin E2 group, and forceps delivery or primary cesarean sections were performed less often when prostaglandin E2 was used (24% versus 44%, p less than 0.05). The outpatient administration of a single dose of prostaglandin E2 gel is safe in the uncomplicated postdate pregnancy and was found to significantly change the unripe cervix, enhance the onset of labor, minimize the need for oxytocin administration, and encourage a spontaneous vaginal delivery. Our purpose was to compare the safety and efficacy of intravaginal prostaglandin E1, misoprostol, with that of intracervical prostaglandin E2 (Prepidil gel) for labor induction.
                One hundred three patients with an indication for induction of labor were randomly assigned to induction with prostaglandin E1, 50 micrograms intravaginally, or with Prepidil gel, 0.5 mg intracervically, every 4 hours until active labor.
                Four patients were excluded, leaving 49 patients who received prostaglandin E1 and 50 who received prostaglandin E2. The time from start of induction to vaginal delivery was significantly shorter in the prostaglandin E1 group (11.4 vs 18.9 hours, p < 0.001), and fewer patients in the prostaglandin E1 group required oxytocin augmentation (23% vs 55%, p < 0.005). No significant differences were noted in mode of delivery or in adverse maternal, fetal, or neonatal effects.
                Intravaginal prostaglandin E1 is a more effective, lower-cost agent for induction of labor than is intracervical prostaglandin E2 gel and is comparable in safety. A study was designed to see if incorporating intracervical administration of prostaglandin could affect the outcome of postdate pregnancies. All patients with verified dates, at least 41 6/7 weeks pregnant and enrolled in an antepartum testing schedule were randomized in a double-blind fashion to receive either 0.5 mg of prostaglandin E2 (PGE2) suspended in methylcellulose or a placebo of the gel alone. The gel was inserted directly into the cervical canal after the patient had a reactive/negative contraction stress test. The patient was then observed on an external fetal monitor for an hour before going home. A total of 23 patients received PGE2, and 20 received the placebo. Results were analyzed for the following: change in the Bishop score, lag time from dosage to delivery, spontaneous versus induced labor, cesarean section rate, length of labor and neonatal outcome. There were no significant differences between the groups except in the incidence of patients going into labor within 72 hours. The results indicate that, in general, 0.5 mg of intracervical PGE administered at greater than or equal to 41 6/7 weeks without subsequent oxytocin induction of labor did not appear to significantly alter the obstetric outcome. Ripening of the cervix by intravaginal application of a prostaglandin-containing gel is evaluated. Thirty patients with an unfavorable cervix needing labor induction were studied in a double-blind, prospective fashion. The prostaglandin gel proved superior to placebo in ripening the cervix (P less than .05), reducing induction failures (P less than .025), diminishing the oxytocin dosage necessary for induction (P less than .05), and lowering the rate of cesarean section (.05 less than P less than .1). One hundred fifty additional patients with varying Bishop scores and differing clinical situations were also studied. There were 35 cesarean sections (23.3%), nine failed inductions (6%), a spontaneous labor rate of 46%, and an average Bishop score change of 2.5. Twenty patients with premature rupture of the membranes and an unfavorable cervix received a modified gel containing 2.5 mg of prostaglandin E2. Average Bishop score change was 2.9, and there was a 55% incidence of spontaneous labor. To determine whether weekly outpatient administration of prostaglandin gel or estrogen cream initiated labor in women with an unfavorable cervix.
                All uncomplicated pregnancies at term gestation who were candidates for a vaginal delivery with a Bishop score of < or = 6 were randomly assigned to receive on a weekly basis: prostaglandin E2 gel (n = 41); estrogen cream (n = 44); or inert lubricant jelly (n = 43).
                In the three groups no differences were observed among 128 subjects in the weekly Bishop scores, cervical dilatation or gestational age upon admission to the labor and delivery suite, the percentage of patients presenting with spontaneous labor or ruptured membranes, the number of post-date inductions or neonatal outcome.
                Weekly out-patient cervical ripening using either prostaglandin gel or estrogen in women with an unfavorable cervix at 37 weeks' gestation was no more effective than a placebo in Bishop score improvement or in preventing post-date inductions. For the purpose of reducing the side effects and complication rate when inducing second trimester abortion, intracervically administered PGE2 gel was tested for the first time and compared with a single intraamniotic instillation of PGF2 alpha by a randomized allocation of 41 consecutive patients in the 13th to 24th week of gestation. In both groups the treatment was supplemented with oxytocin 5 - 6 hours after starting the induction. The methods proved of equal value as regards the abortion success rate and the induction-abortion interval, whereas the incidence of gastrointestinal side effects on intracervical application of PGE2 gel was only half as high and the occurrence of diarrhea significantly lower (p less than 0.05) with this non-invasive method than with intraamniotic PGF2 alpha. Intracervical PGE2 gel also possessed other advantages, being int. al. more acceptable by the patients and technically easier to administer. A prospective study comparing three management schemes for patients at term with premature rupture of membranes was performed.
                One hundred forty patients were randomized to one of three study groups: prostaglandin E2, placebo, or oxytocin. Patients randomized to prostaglandin E2 and placebo received vaginal suppositories containing 3 mg prostaglandin E2 or glycerin only, respectively; suppositories were administered in a double-blind fashion, on one or two occasions, 6 hours apart. Oxytocin was given only if labor was not established after 12 hours or to augment inadequate labor. In patients randomized to oxytocin labor was induced with intravenous oxytocin. The time interval to delivery, delivery outcome, and complications were analyzed.
                Patients receiving prostaglandin E2 were more likely to be in labor after one suppository and to be delivered without the addition of oxytocin when compared with placebo. The time interval to delivery was shorter with prostaglandin E2 and oxytocin induction versus placebo ("expectant management"). The incidence of maternal infection was lowest in patients with labor induced by prostaglandin E2. Although the overall cesarean section rate was low, there was a trend toward a lower rate with prostaglandin E2 induction. No adverse effects were observed with prostaglandin E2.
                Prostaglandin E2 can be used successfully to induce labor after premature rupture of membranes at term with greater ease of administration when compared with oxytocin. In a material of 88 patients with premature rupture of the membranes and unripe cervix, a comparative investigation was undertaken to compare the effects of prostaglandin E2 (PGE2) vaginal tablets and intravenous oxytocin on induction of labour. The patients were subdivided at random into two groups: 42 patients treatment with PGE2 and 46 treatment with intravenous oxytocin. The results did not reveal any significant differences in the numbers of successful inductions regardless of the Bishop score at the commencement of stimulation but the duration of induction was found to be briefer in the oxytocin group. No significant differences were observed in the numbers of instrumental interventions in the two groups nor in the frequencies of side effects and in the employment of analgesics. Treatment with PGE2 vaginal tablets is considered to be more acceptable by the patients and easier for the staff to use. The tablets were just as safe and reliable in use as intravenous oxytocin for induction of labour in cases of premature rupture of the membranes and Bishop scores less than 6, but the duration of induction was significantly longer. Our purpose was to evaluate the effectiveness of oxytocin, prostaglandin E2 intracervical gel, and estradiol cream for ripening the very unfavorable cervix in patients requiring induction of labor at term.
                This prospective, randomized study was conducted in a population of women with a very unfavorable cervix (Bishop score < 4) requiring induction of labor. The patients received prostaglandin E2 gel (0.5 mg) intracervically (three doses 6 hours apart), 4 mg estradiol cream in the anterior fornix of the vagina (three doses 6 hours apart), or oxytocin at induction per protocol with an infusion pump.
                Ninety-nine women were recruited into this trial and evenly distributed among the three groups. The demographics of maternal age, race, parity, gestational age, initial Bishop score, and indication for induction were similar among the groups. The incidence of cesarean deliveries was similar in the three groups with approximately 59% of pregnancies delivered abdominally. For patients undergoing abdominal delivery the maximum cervical dilatation among the oxytocin, estradiol, and prostaglandin E2 groups was similar (3.90 +/- 3.02 cm, 3.63 +/- 2.79 cm, and 4.65 +/- 2.78 cm, respectively; p > 0.05). For all patients birth weight and Apgar scores at 1 and 5 minutes were comparable across all regimens (p > 0.05). In the subset of patients delivered vaginally patients receiving oxytocin for cervical ripening had the greatest improvement in Bishop score over baseline (p = 0.023) with an improvement of 7.08 +/- 2.42.
                No differences were detected among prostaglandin E2 gel, estrogen, and oxytocin in relation to cervical ripening in patients with an unfavorable cervix at term who require an induction of labor. Patients with a very unfavorable cervix at term who require delivery may benefit from serial ripening and inductions.
Intracervical prostaglandins are effective compared to placebo, but appear inferior when compared to intravaginal prostaglandins.