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.
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.
Intracervical prostaglandins are effective compared to placebo, but appear inferior when compared to intravaginal prostaglandins.