Ripening of the uterine cervix and induction of labour at term with prostaglandin E2 in viscous gel. [Multicenter experiences with the intracervical administration of a new PGE2 gel in labor induction]. A randomized trial comparing vaginal and cervical prostaglandin gel for cervical ripening and labor induction. [Comparison between prostaglandin E2 gel and oxytocin in medically indicated labor induction]. Prostaglandin E2 cervical ripening without subsequent induction of labor. Premature rupture of membranes near term: induction of labor with endocervical prostaglandin E2 gel or intravenous oxytocin. Prostaglandin E2 gel for cervical ripening in patients with an indication for delivery. Sequential outpatient application of intravaginal prostaglandin E2 gel in the management of postdates pregnancies. Vaginal administration of PGE2 for induction of labor stimulates endogenous PGF2 alpha production. Intravaginal prostaglandin E2 for cervical ripening and initiation of labor. Comparison of a multidose gel and single, controlled-release pessary. 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. Cervical ripening: a randomized study comparing prostaglandin E2 gel to prostaglandin E2 suppositories. Cervical ripening and labor outcome with preinduction intracervical prostaglandin E2 (Prepidil) gel. Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets is equally effective. 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. A randomized trial of two preparations of vaginal prostaglandin for pre-induction cervical ripening. 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. Prostaglandin E2 gel compared to oxytocin for medically-indicated labour induction at term: a controlled clinical trial. Endocervical prostaglandin E2 gel for preinduction cervical softening. A comparison of prostaglandin E2 gel and prostaglandin F2 alpha gel for preinduction cervical ripening. Prostaglandin E2 gel versus misoprostol for cervical ripening in patients with premature rupture of membranes after 34 weeks. Open randomized comparison of prostaglandin E2 given by intracervical gel or vagitory for preinduction cervical ripening and induction of labor. The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects. Improved intravaginal controlled-release prostaglandin E2 insert for cervical ripening at term. The Prostaglandin E2 insert Study Group. Hygroscopic cervical dilators and prostaglandin E2 gel for preinduction cervical ripening. A randomized, prospective comparison. Randomized trial of administration of prostaglandin E2 gel for induction of labor in the morning or the evening. A randomized trial of management of pre-labor rupture of membranes at term in multiparous women using vaginal prostaglandin gel. A comparison of PGE2 and PGF2 alpha vaginal gel for ripening the cervix before induction of labour. [Ripening of the cervix uteri at term by a single intracervical application of prostaglandin E2 gel]. Cervical ripening: randomized comparison of intravaginal prostaglandin E2 gel with prostaglandin E2 gel plus laminaria tents. Comparison of intravenous oxytocin and vaginal prostaglandin E2 gel in women with unripe cervixes and premature rupture of the membranes. Maternal plasma bicycling PGE2 levels following vaginal administration of prostaglandin E2 pessaries in full term pregnancies. Comparison of intravenous oxytocin with and without vaginal prostaglandin E2 gel in term pregnancy with premature rupture of membranes and unfavorable cervix. Cervical ripening before induction of labor: a randomized trial of prostaglandin E2 gel versus low-dose oxytocin. Randomized trial of intracervical prostaglandin E2 gel and intraamniotic prostaglandin F2 alpha for induction of second trimester abortion. A randomized clinical trial of prostaglandin E2 intracervical gel and a slow release vaginal pessary for preinduction cervical ripening. A randomized prospective trial comparing single dose prostaglandin E2 vaginal gel with forewater amniotomy for induction of labour. A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis. Comparative study of various intracervically administered PG gel preparations for termination of first trimester pregnancies. Induction of labor by vaginal prostaglandin E2. A randomized study comparing pessaries with vaginal tablets. Induction of labor by intra-cervical PGE2 in viscous gel. Mechanism of action and clinical treatment routines. A randomized trial of prostaglandin E2 gel and extra-amniotic saline infusion with high dose oxytocin for cervical ripening. Randomized, double-blind trial of prostaglandin E2 intravaginal gel versus low-dose oxytocin for cervical ripening before induction of labor. [Artificial induction of labor at term for medical reasons. Comparison of 2 technics for labor induction, oxytocin + early artificial rupture of the membranes versus prostaglandin E2 vaginal gel. Open randomized controlled study].
In order to achieve ripening of the uterine cervix or induce labour in patients at term with an unfavourable cervical state, 1 mg of prostaglandin E2 (PGE2), suspended in a viscous gel, was instilled into the cervical canal. In a pilot study, 41 patients received the PGE2-gel. Twenty-three of these, (56%), went into labour, and delivery occurred without further stimulation within 15 hours. In the remaining 18 patients, there was a marked improvement of the cervical state, which changed from an average (modified) Bishop score of 2.5 to 6.1 within 24 hours. In a double-blind study comprising 20 nulliparae, 10 received gel containing PGE2 and 10 gel without prostaglandin. Cervical state did not change significantly (Bishop score 3.6 and 4.0) after 24 hours in patients receiving placebo gel. In those receiving PGE2 gel, 8 went into labour and were delivered without further induction within 13 hours. Two patients showed an increase in Bishop score from 3 to 6 and 7, respectively, after 24 hours. They were then induced by oxytocin and delivery occurred after 8 and 10 hours. The results suggest that administration of PGE2 intracervically can induce ripening of the cervix in patients at term with an unfavourable cervical state, and thus facilitate delivery. With the participation of four Swiss obstetric clinics, medically indicated inductions of birth (with living fetuses) were performed using a new, stable PGE2 gel, and documented according to a uniform protocol. The study was conducted to investigate the efficacy of 0.5 mg of PGE2, in 2.5 ml of a vehicle (Triacetin) not yet commercially available, for local cervical maturation (n = 41). Thirty-nine patients selected by prospective randomization, in whom birth was induced conventionally, served as a control group. The efficiency of the prostaglandin gel alone or respectively with additional administration of oxytocin was evaluated on the basis of the clear changes in the cervical findings observed within 12 or respectively 24 hours, the spontaneous births, or, in the case of cesarean deliveries, according to the pelvic score. Application of PGE2 alone led to impressive changes of the cervix score and, in 34 of the 41 cases, to regular contractions after an average time of 87 minutes. After 12 hours, prior to administration of oxytocin, 43% of the patients were already delivered. The combination of locally applied PGE2 gel with conventional oxytocin induction significantly increases the number of successful inductions. The percentage of unsuccessfully attempted inductions was reduced to 24% in the PGE2 gel group as compared to 44% in the control group. To compare the effectiveness of intravaginal and intracervical prostaglandin E2 (PGE2) gel for cervical ripening, defined as an increase of 3 or greater in the Bishop score, and for induction of labor.
                Women with Bishop score 4 or less were assigned randomly to receive either 2 mg PGE2 intravaginally (n = 125) or 0.5 mg intracervically (n = 122). If the Bishop score was 4 or less, another dose of PGE2 was given after 6 hours, and up to two additional doses were given 6 hours apart on the second day. An oxytocin infusion was begun when the Bishop score was 5 or greater in absence of spontaneous labor, or if labor had not begun on the third day.
                Baseline characteristics of the two groups were similar. Survival analysis showed that time from PGE2 application, to obtain an increase of 3 or greater in the Bishop score, to vaginal delivery was significantly shorter with intravaginal PGE2 (logrank test: P = .003 and < .001 after stratification for parity, respectively). Thirty-one percent of women in the intravaginal gel group required oxytocin for labor induction compared with 63% in the intracervical group (P < .001). There were no significant differences in relation to cesarean delivery rate, Apgar scores at 5 minutes, and arterial umbilical cord pH, although the power of our study was limited to detect differences in proportions of adverse outcomes.
                Vaginal PGE2 gel is more effective than intracervical gel for cervical ripening and labor induction. 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. 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. We have studied the influence of endocervical application of 0.4 mg prostaglandin E2 (PGE2) in gel on the clinical outcome of pregnancies of at least 36 weeks' duration complicated with premature rupture of the membranes (PROM) and unripe cervix, (modified Bishop score of 7 or less). There were 579 women in the study. The PGE2 gel was applied within the first 12 hours after PROM. The first 60 women were randomly divided into controls given oxytocin infusions and experimental subjects given PGE2 gel. All others were given PGE2 gel, and the results were compared with those obtained in patients with similar criteria who were treated with oxytocin infusions during the preceding year. The clinical outcome was significantly better in the PGE2-treated patients than oxytocin-infused patients. PROM to delivery interval and the incidence of operative deliveries were significantly reduced. No adverse effects on the neonates were observed and the incidence of neonatal infection declined. It is concluded that cervical ripening with PGE2 gel in patients with PROM and unripe cervix near term significantly improves the outcome for both mother and child. To determine if labor can be induced safely and efficiently in patients with a medical or obstetric indication for delivery before 41 completed weeks of gestation by pre-induction cervical ripening with prostaglandin (PG) E2 gel.
                One hundred eighteen women with confirmed indication for induction of labor before 41 completed weeks were randomized in a double-blind fashion to either intracervical PGE2 gel or placebo before induction by a standard oxytocin protocol. Data regarding the change in Bishop score, interval to complete dilation, maximal oxytocin dose required to establish labor, and route of delivery were collected. Apgar scores and umbilical artery pH were also recorded.
                The maximum oxytocin dose required to establish progressive labor was significantly lower in the PGE2 group (10.06 +/- 8.50 versus 13.35 +/- 9.27 mU/minute, P = .014). The cesarean rate was also significantly lower in the PGE2 group (13.1 versus 31.6%, P = .016).
                Pre-induction intracervical deposition of 1 mg PGE2 gel decreased the amount of oxytocin required to induce progressive labor and decreased the cesarean rate in patients who had medical or obstetric indications for delivery before 41 completed weeks. This was accomplished without negative effect on Apgar score or umbilical artery pH. A randomized blinded investigation was undertaken to determine the efficacy and safety of sequentially applied intravaginal prostaglandin E2 (PGE2) gel for accelerating cervical ripening in an outpatient setting in low-risk prolonged pregnancies. Fifty women with uncomplicated pregnancies at or beyond 41 weeks' gestation and Bishop scores below 9 received twice-weekly outpatient administration of gel containing 2.0 mg of PGE2 or placebo. Thirty nulliparas and 20 multiparas were enrolled. The PGE2 gel failed to improve cervical ripening over placebo, as judged by Bishop scores. There was no difference between the groups in gestational age on admission to the labor and delivery suite, number of gel applications, requirement for oxytocin, incidence of cesarean delivery, or neonatal outcome. Only two patients (4%) experienced regular uterine contractions after gel insertion; these subsided spontaneously in both. None of the subjects experienced labor, tetanic contractions, evidence of fetal distress, or any other side effects related to gel insertion. We conclude that PGE2 gel in this dosage may be used safely in an outpatient setting, but more frequent application or earlier initiation may be required to produce a clinical effect. Prostaglandin E2 is effective for induction of labor but many preparations exist using a variety of vehicles from which the active ingredient may not be equally available. Plasma concentrations of bicyclic PGE2 metabolite (PGEM) and 13, 14-dihydro, 15-keto PGF2 alpha (PGFM) were measured following administration of a 3mg PGE2 vaginal tablet or 1mg PGE2 vaginal gel to twenty-four parous women with favorable induction features, randomly allocated to receive one or other preparation. PGEM increased rapidly following both administration of the 3mg PGE2 vaginal tablet and the 1mg PGE2 vaginal gel, reaching a peak within 40 minutes of PGE2 administration. The maximal rise in PGEM in the gel group correlated directly with the change in cervical score and inversely with the need for augmentation with oxytocin and the induction-delivery interval. A secondary rise in PGFM was noted in both groups 3-4 hours following PGE2 administration. The magnitude of the increase in PGE2 may be important in the clinical response to PGE2 administration, while PGE2 absorption may switch-on endogenous PGF2 alpha production, similar to what is seen in spontaneous labor. 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. 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. Prostaglandin (PG) E2 has proven effective in many studies as a pre-induction agent for cervical ripening. The purpose of this study was to compare the efficacy of a 5-mg dose of PGE2 prepared gel with that of a quartered PGE2 20-mg suppository. Previous studies have documented uniform distribution of PGE2 in the suppository. After 90 patients entered the study, there appeared to be an unacceptable rate of hyperstimulation following the induction dose using the suppository. The study was discontinued, and data analysis revealed a 24% hyperstimulation rate with the quartered suppository versus 0% with the gel. The successful vaginal delivery rates were equivalent, at 75% for the gel and 66% for the suppository. The 5-mg quartered suppository appeared to initiate an unacceptable amount of uterine activity, much greater than with the 5-mg gel dose. 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. Prostaglandin E2 for local application has been widely used for preinduction cervical ripening in cases presenting with an unfavorable cervical state. The optimal way of administering prostaglandin E2, however, remains unclear. The aim of this study was to compare the effect of multiple application of 0.5 mg Minprostin intracervical Gel to the effect of 3 mg Minprostin vaginal tablets in priming the uterine cervix and inducing labor in an open, prospective, randomised study.
                PGE2 was applied up to three times a day for two days until ripening was obtained or labor induced. In case no progress took place amniotomy was performed and i.v. oxytocin stimulation one hour later if necessary. A total of 208 pregnant women, consecutively admitted for induction of delivery, with Bishop Scores 0-5, were included.
                Minprostin gel (group I) and Minprostin tablets (group II) were equally effective in ripening the cervix. Delivery within 48 hours was achieved in 59% and 63% respectively. The mean number of applications was 2.6 (s.d. 1.6) and 2.7 (s.d. 1.3) respectively. In case more than four doses were required no further effect was seen on delivery rates. Rates of cesarean section (performed in 15% and 18% respectively), labor induction (3%/1%), drop outs (14%/12%) and failed inductions (10%/5%) were comparable. Patients in group I had a significantly lower demand for analgesia. A significantly shorter induction-delivery interval in group II was seen in patients with preinduction Bishop scores 3-5 compared to patients with Bishop scores 0-2. Side effects were few. Both procedures appear safe.
                Cervical ripening and induction of delivery by local administration of prostaglandin E2 gel or vaginal tablets in cases presenting with an unfavorable cervical state is equally effective. 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. To compare two prostaglandin (PG) E2 preparations for pre-induction cervical ripening in a randomized clinical trial.
                Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women. Outcomes assessed were induction failure, need for labor augmentation, pain relief requirements, fetal heart rate (FHR) abnormalities, operative delivery rate, induction-to-delivery interval, neonatal condition, and occurrence of uterine hyperstimulation.
                There was no statistical difference in pre- and post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.15-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi 2 = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative delivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in the overall rate of failed induction, cesarean delivery, rate of assisted delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition.
                When compared with the PGE2 tablet, the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome. Whereas the gel was associated with an increase in significant FHR abnormalities, the tablet was associated with an increase in the rate of operative delivery for poor progress in labor. 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. A clinical trial was carried out to compare the efficacy and tolerance of two modes of induction of labour: vaginally administered prostaglandin E2 gel vs intravenous perfusion of synthetic oxytocin. Fifty women with pregnancy at or near term in whom prompt vaginal delivery was clinically indicated were divided at random into sub-groups of 25 each. Initial dose of PGE2 gel was 1 mg followed by another application of 1 mg or 2 mg 6 hours later in case active labour stage has not been reached. Progressive oxytocin perfusion began with 1 mU/min., being increased gradually every 20 minutes until efficacious uterine dynamics were attained. Data were recorded on entry of age, parity, gestation age, cervical dilatation, Bishop score, indication for induction. Continuous materno-foetal monitoring was carried out during the induction period. Results were evaluated from induction/delivery time, type of delivery, maternal and foetal condition, and any side-effects which developed. Apart from a higher number of instrumental deliveries in the PGE2 gel series, which was not related to the induction method, there was no significant difference between any of the variables evaluated, both methods producing active labour in approximately 70% of the patients within 12 hours. The authors stress, however, the convenience, both for patients and hospital staff, of the administration of an intravaginal induction agent over a systemic therapeutic method of induction. 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. 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 compare intravaginal misoprostol to prostaglandin (PG) E2 for cervical ripening in women with premature rupture of the membranes (PROM) after 34 weeks of gestation.
                Women with PROM after 34 weeks of gestation and an unripe cervix were randomized to receive PGE2 (2.5 mg) or misoprostol (50 microg). Both agents were placed intravaginally immediately after randomization, and the dose was repeated 6 hours later if necessary. After another 6 hours from the second insertion, oxytocin treatment was started if labor had not begun. Forty patients in each group were required to show a 30% improvement in delivery within 12 hours in the misoprostol group.
                One hundred nine patients were randomized; 54 were assigned to misoprostol and 55 to PGE2. Important demographic and clinical characteristics were similar between the groups. The mean time from first insertion to delivery was 16.4 hours in the misoprostol group and 22.0 hours in the PGE2 group. A second dose was required less frequently in the misoprostol group (22% vs 62% in the PGE2 group), and the percentage of patients delivered within 12 hours was higher in the misoprostol group (41% vs 16%). Tachysystole occurred in 20% and 6% of women in the misoprostol and PGE2 groups, respectively. Hyperstimulation occurred in 9% and 0%, and cesarean delivery in 19% and 26% of women in the misoprostol and PGE2 groups, respectively. Neonatal outcome was similar between groups.
                Intravaginal misoprostol is more effective than local PGE2 application to treat PROM after 34 weeks of gestation, but tachysystole occurs more commonly with misoprostol. 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. 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 purpose of this study was to determine if prostaglandin E2 (PGE2) in a controlled-release vaginal insert with retrieval system can produce cervical ripening at term. This was a multicenter, double blind, randomized, placebo-controlled study involving 206 patients with 102 receiving active agent. A successful outcome was defined as a change in Bishop score of > or = 3, or a Bishop score of > or = 6 at 12 h or delivery within 12 h of the insert placement. Analysis was by Fisher's exact test, Wilcoxon's two-sample rank-sum test, and Student's t-test where appropriate. One hundred ninety-three women completed the protocol. Initial Bishop scores were 2.6 +/- 1.2 and 2.5 +/- 1.4 in the PGE2 and placebo groups, respectively. The incidence of cesarean delivery was identical in the two groups. Uterine hyperstimulation lasted 2-13 min in 5 PGE2 patients (4.9%) with 1 patient requiring tocolysis. More patients in the PGE2 group had a change in Bishop score of > or = 3 (62% vs. 40%; P = 0.002), a Bishop score > or = 6 after 12 h (46% vs. 34%; P = 0.11), and vaginal delivery within 12 h (6.5% vs. 1%; P = 0.055). Sixty-five percent of PGE2 group patients had a successful outcome vs. 44% of control patients (P = 0.001). In conclusion, when administered in a controlled-release vaginal insert with a retrieval system, PGE2 is effective in promoting cervical ripening at term. A randomized, prospective study compared the safety and efficacy of hygroscopic cervical dilators (36 patients) with intracervical prostaglandin E2 (PGE2) gel (38 patients) in preinduction cervical ripening. Maternal age, gestational age and parity were similar in both groups. Both groups had similar cervical Bishop scores upon admission. The change in the cervical score was 3.0 +/- 0.3 (mean +/- SEM) in the dilator group and 2.8 +/- 0.4 in the PGE2 group (P = .7). The mean length of time from amniotomy to delivery was similar in both groups (10.1 +/- 1.0 and 10.3 +/- 1.3 hours, respectively) (P = .9). The proportions of patients in each arm of the study undergoing cesarean section were similar. Eight cesarean sections (21.0%) were performed in the PGE2 group; seven (19.4%) were performed in the dilator group (P = .9). Maternal morbidity, five-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the two groups. Because patients were required to stay in the labor-and-delivery unit for four to six hours of fetal monitoring after PGE2 application, the costs were higher in that group. The dilators and PGE2 gel appear comparable in efficacy as preinduction cervical ripening agents. The need to monitor patients receiving PGE2 gel, however, appears to favor the choice of the dilators from a cost and convenience perspective. To compare the outcome of induction of labor and patient's preferences using a protocol with the first dose of prostaglandin E2 endocervical gel in the evening versus a protocol with the first dose in the morning.
                We performed a randomized trial comparing administration of prostaglandin E2 endocervical gel in the morning with administration of prostaglandin E2 gel in the evening, followed if necessary by a second dose being given after six hours if labor had not started or the cervix was still unripe. Formal induction of labor by amniotomy and oxytocin infusion was performed the morning after the initial prostaglandin E2 dose. Patients' preferences were assessed using a questionnaire that was completed after delivery.
                Tertiary care hospital in the Netherlands with 1,600 deliveries per year.
                One-hundred and twenty-six women with viable singleton pregnancies at term who had induction of labor with prostaglandins.
                Time of delivery (daytime, evening or night) and patient's satisfaction.
                Fifty-eight women were allocated for administration of gel in the morning, whereas 68 had their gel in the evening. Administration of gel in the evening did not significantly reduce delivery between 23.00 hours and 08.00 hours, although there was a reduction in delivery between 23.00 hours and 08.00 hours in nulliparae. None of the multiparous women delivered between 18.00 hours and 23.00 hours after induction of labor in the evening. The relative risk for delivery by vacuum or forceps was increased after allocation of gel in the evening (4.2; 95% confidence limits 1.4 to 13). Patients' preferences favored administration of gel in the morning.
                There was no benefit in starting induction of labor with prostaglandin E2 in the evening, compared with starting in the morning. To compare conservative management of pre-labor spontaneous rupture of membranes (SROM) with the use of prostaglandin (PG) E2 in healthy parous women at term (gestational age at least 37 weeks).
                An open randomized study was conducted with 100 parous women; 50 were treated conservatively for 24 hours, and 50 were managed actively using PGE2 gel (1 mg), administered at admission and repeated 6 hours later if labor was not established. Both groups received intravenous oxytocin if labor did not start within 24 hours after admission.
                The use of PGE2 gel led to a significant reduction in the mean interval (+/- standard error of the mean) from SROM to onset of labor: 17.26 +/- 1.51 hours in the conservative group versus 6.50 +/- 1.23 in the PGE2 group. A significantly smaller proportion of subjects required oxytocin in the PGE2 group (12 versus 38%, P < .02). The two groups were comparable with respect to analgesic requirements. Within 24 hours of SROM, 80% of the women in the PG group and 56% in the conservative group had delivered (P < .02). Most women delivered vaginally, 96% of those managed conservatively and 100% of those managed actively with PGE2.
                Active management using PGE2 gel in parous women with pre-labor SROM significantly improves the time to delivery without influencing the cesarean rate or fetal-maternal infective morbidity. 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. 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. The purpose of this study was to evaluate the efficacy of adding laminaria tents to sequential intravaginal prostaglandin E2 (PGE2) gel for cervical ripening. A prospective, randomized study was conducted from October 1994 to May 1995. Pregnant women with maternal or fetal indications for induction of labor at > or = 37 weeks gestation and a Bishop score of < or = 4 were eligible. Nineteen patients received laminaria tents in addition to 4 mg PGE2 gel, while 25 patients received PGE2 gel alone. After 4 hr, the laminaria tents were removed and the gel was continued in both groups at 4-hr intervals. Induction with oxytocin was initiated after a Bishop score of > or = 5 was achieved. The groups were comparable with respect to maternal age, parity, gestational age, reason for induction, and initial Bishop score. The addition of laminaria tents to sequential PGE2 gel did not statistically improve the time to a favorable cervix (control group 12.7 +/- 8.5 hr (95% CI, 9.1-16.3) and study group 10.9 +/- 7.1 hr (95% CI, 7.5-14.3) (P = 0.59). The 6-hr difference from the time of the initial PGE2 gel placement to delivery was not detected (control group 22.4 +/- 11.2 hr, 95% CI 17-27 and study group 23.4 +/- 13.1 hr, 95% CI 17-29.6 (P = 0.79). The combination approach of laminaria tents and PGE2 gel did not have a significant impact on the vaginal delivery rate, with 28.0% of patients in the control group and 26.3% of patients in the study group undergoing cesarean section (P = 0.90). Maternal and neonatal complications were rare in both groups. We had insufficient evidence to show that the addition of laminaria tents to PGE2 gel improved cervical ripening, the induction to delivery interval, or the cesarean section rate in patients at term undergoing induction of labor. To induce cervical priming and labor, 20 nulliparous term pregnant women with premature rupture of the membranes and unfavorable cervical states were randomly given either oxytocin intravenously or 4 mg prostaglandin E2 in gel intravaginally. One of ten women receiving oxytocin had a favorable cervical state within five hours and vaginal delivery within 24 hours after the start of the infusion compared with six of ten women after prostaglandin E2 gel application. This difference is statistically significant (P less than .01). The number of instrumental deliveries was nine (four cesarean sections and five vacuum extractions) in the oxytocin-treated patients compared with only two vacuum extractions in women who received prostaglandin E2 gel. This difference is also statistically significant (P less than .01, Fischer exact test). In a subsequent open study, 4 mg prostaglandin E2 gel was applied vaginally to 17 term pregnant women of mixed parity with premature rupture of the membranes and unfavorable cervixes. In 12 women a favorable cervical state was achieved within five hours after gel application, and all these women were delivered within 24 hours. None of the women required cesarean section but two required delivery by vacuum extraction. There were no perinatal losses, but two infants in the oxytocin-treated group had Apgar scores less than 7 at five minutes. At pediatric follow-up after two and six months, all infants were normal. In both obstetric and perinatal outcome prostaglandin E2 gel thus seems to be superior to oxytocin for labor induction in term pregnant patients with premature rupture of the membranes and unfavorable cervixes. Plasma levels of bicyclic PGE2 (PGE2M) were measured after administration of a 5mg, PGE2 slow release hydrogel pessary and a 3mg vaginal tablet (Upjohn). Twenty-four women of low parity with favourable induction features were randomised to receive either the hydrogel pessary or the vaginal tablet. A single pessary was administered and amniotomy was performed after 4 hours. Augmentation with oxytocin was carried out after amniotomy if required. Both groups showed a rise in plasma PGE2 levels in keeping with the release profiles of the pessaries. Wide interindividual differences in absorption were found. Forty-seven nulliparous term pregnant women with PROM and unfavorable cervix, were randomly divided into 23 patients who were observed for four hours then followed by intravenous oxytocin, and 24 patients who were given 3 mg PGE2 gel intravaginally then followed by intravenous oxytocin four hours later. No statistically significant difference was observed between the two treatment groups with regard to Bishop score four hours after observation, intravenous oxytocin to delivery time, Apgar score at 1 and 5 minutes and maternal puerperal complications in both groups. It can be concluded that PGE2 did not significantly improve Bishop score or shorten the induction to delivery time in cases of PROM with unfavorable cervix. Intravenous oxytocin is still preferable both in terms of cost and effectiveness. The purpose of this study was to compare prostaglandin E2 gel and a low-dose infusion of oxytocin for cervical ripening before labor induction.
                A total of 158 women were randomized to receive either two intracervical doses of 0.5 mg prostaglandin E2 gel 6 hours apart or 12 hours of intravenous oxytocin up to 4 mlU/min. After cervical ripening labor was induced with high-dose oxytocin infusion and amniotomy.
                There was no difference between the prostaglandin E2 and low-dose oxytocin groups in the likelihood of being in labor or having a Bishop score favorable for induction after ripening (64.2% vs 52.0%, p = 0.12) or in the incidence of vaginal delivery (75.9% vs 74.7%). Prostaglandin E2-treated patients were delivered sooner (20.2 +/- 8.1 hours vs 25.0 +/- 10.5 hours, p = 0.002). Among delivered patients the likelihood of vaginal delivery within 24 hours was greater with prostaglandin E2 ripening (63.7% vs 47.2%, p = 0.04), but there was no difference at 36 hours (76.2% vs 75.0%). Uterine hyperstimulation and fetal distress during ripening occurred only in the prostaglandin E2 group, at a rate of 4.8%.
                After cervical ripening with prostaglandin E2 gel or low-dose oxytocin vaginal delivery can be expected in three fourths of patients within 24 to 36 hours. We recommend that patients with an unfavorable cervix who require delivery undergo cervical ripening and induction of labor rather than automatic delivery by cesarean section. 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. 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. A prospective randomized parallel-group study was carried out to compare the efficacy of a single dose vaginal prostaglandin E2 gel with forewater amniotomy for induction of labour at term in 260 parturients (110 primigravid and 150 parous women) with low risk pregnancy and favourable cervix. In the prostaglandin E2 (PGE2) managed group, the primigravidae were treated with 2 mg PGE2 gel and parous patients with 1 mg PGE2 gel. Forewater amniotomy was performed 4 h later, or sooner if women requested analgesia. In the amniotomy group, artificial forewater amniotomy was carried out and a repeat cervical assessment done 4 h later, or sooner if women requested analgesia. In both groups, intravenous oxytocin was established if there was evidence of disordered uterine activity, 6 h after the start of initial intervention. An assessment of consumers' views was carried out by using a standardized questionnaire completed 48 h after delivery. There was a significant reduction in the requirement for oxytocin augmentation in women treated with PGE2: primigravidae, odds ratio (OR), 0.27 and 95% confidence interval (CI), 0.12-0.61; multiparae, OR, 0.19 and 95% CI, 0.08-0.45. Fewer primigravidae managed with PGE2 gel required epidural analgesia (OR, 0.16; 95% CI, 0.06-1.00). Fewer parous women managed with PGE2 gel required parenteral opiates (OR, 0.44; 95% CI, 0.23-0.85) and more women required inhalation analgesia or no analgesia (OR, 2.22; 95% CI, 1.76-2.79). The intervention to delivery intervals were shortened in PGE2 groups independent of parity but the differences were not significant.(ABSTRACT TRUNCATED AT 250 WORDS) 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. In a randomized, double-blind study, 30 healthy, nulliparous women of similar gestational age were given intracervical applications of 0.5mg PGE2, 0.05mg Sulprostone or 0.1mg Sulprostone gel in order to soften the cervix prior to curettage for first trimester termination of pregnancy. The preparations were administered 8 hours before curettage. The number of complete and incomplete abortions, ease of passage through the cervical canal, as measured by a tonometer before and 8 hours after the administration of prostaglandin, the degree of pain experienced and the quantity of analgesics required, plus the frequency of systemic side effects were all always assessed by one trialist. With regard to the rate of abortion and cervical softening, the administration of 0.1mg Sulprostone gel proved the most effective method. However, in comparison with the others, it also caused the greatest degree of pain and necessitated the greatest use of analgesics. The softening effect of the prostaglandin E2 gel was significantly less and in this group there were two cases of cervical lesion due to tenaculum laceration. The intracervical application of 0.05mg Sulprostone gel is to be recommended for pre-operative ripening of the cervix before termination of pregnancy in the first trimester, as it effectively dilates the cervix and does not cause systemic side effects or pain in the lower abdomen, enough to make treatment necessary. A prospective randomized study of 267 pregnant women was undertaken to compare the efficacy of a pharmacy-prepared 3-mg prostaglandin E2 (PGE2) vaginal suppository with a 3-mg PGE2 vaginal tablet for induction of labor and cervical ripening. No statistically significant difference in success frequency was found between the two groups, either on the first day (72% and 74%, respectively; p greater than 0.05) or on the second day (89% in both groups). There was an equal proportion of women requiring oxytocin augmentation in the two groups, but the slower releasing properties of the vaginal tablet were reflected in a longer mean induction--delivery interval of about 4 h for this group. In both the pessary and the vaginal tablet groups, women who had not gone into labor on the first day showed a statistically significant increment in the Bishop score on the morning of the second day. The frequency of cesarean section was the same in both groups, but instrumental deliveries were more frequent in the vaginal tablet group. It is concluded that PGE2 vaginal tablets--a chemically stable alternative to pharmacy prepared pessaries--appear to be effective as regards cervical ripening as well as for labor induction. Induction of labor in women with immature cervix was accomplished by four different treatment schedules. The case material included a total of 100 subjects, each treatment group having 25 cases: Group A: Intravenous oxytocin; Group B: Intracervical PGE2-gel followed by intravenous oxytocin; Group C: Intracervical PGE2-gel twice with a 12-hour interval; Group D: Intracervical placebo gel twice with 12-hour interval. Oxytocin did not influence the Bishop score (B.S.) unless in the presence of active labor contractions. In contrast, there was an increment in B.S. by 3.6 points on average within 12 hours following PGE2-gel as calculated from data of subjects without signs of contractions. These results support the concept of a local action of PGE2-gel. The increment in B.S. was larger in subjects with very immature cervices (B.S. less than or equal to 2) than in those with moderately immature scores (B.S. 4). A second PGE2-gel instillation did not increase the B.S. above the level achieved by the first application, indicating that pharmacological ripening of the cervix by a single dose of PGE2 results in an effect approaching maximum. The success rate was the same for oxytocin and PGE2-gel treated women during the first 24 hours, when approximately 40% of the women had given birth. The oxytocin group remained at that level of success rate, whereas the PGE2-gel-oxytocin and PGE2-gel X 2 series continued to improve their success rate up to 75%. An interesting finding in the study was that women given PGE2-gel twice did not need intravenous oxytocin stimulation except in a few cases. Our purpose was to compare the efficacy of extra-amniotic saline infusion plus high dose oxytocin with prostaglandin E2 intracervical gel (Dinoprostone) for preinduction cervical ripening.
                166 nulliparous women with term pregnancies, vertex presentation, intact membranes and a Bishop score < or = 4 referred for labor induction were randomly assigned to receive a 0.5 mg PGE2 intracervical gel and extra-amniotic saline infusion (EASI) plus high-dose oxytocin. Changes in the Bishop scores, labor progress, various labor end points and outcomes of labor were assessed. Data were analyzed using chi2 analysis or the Student t-test.
                151 women were studied after 15 exclusions, 75 were assigned to PGE2, and 76 to EASI. The groups were similar in age, race, indication for induction and gestational age. The EASI group had a significant improvement in Bishop score and greater dilation. The mean time to vaginal delivery was 11.4+/-4.8 hours and 18.9+/-6.4 hours for the EASI and PGE2 groups respectively (P=0.001). The cesarean delivery rate was not significantly different between the two groups (25% for the EASI group; 34.6% for the PGE2 group). The cesarean rate due to failure to progress, fetal labor intolerance, and maternal and neonatal outcomes were similar in the two groups.
                Preinduction cervical ripening with EASI plus high dose oxytocin resulted in greater changes in Bishop score, and shorter time to normal vaginal delivery than with PGE2 gel in nulliparous women, without increasing the cesarean rate due to failure to progress or fetal labor intolerance. 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. Labor induction for medical reasons is a situation rather well-controlled by the combination: "oxytocin-amniotomy" when the cervix is favorably open. However, new induction techniques are currently under study, especially vaginal administration of PGE2 which presents the advantage of being simple to administer and better accepted by the patients. This study compared the classical technique, oxytocin perfusion and early artificial rupture of the membranes, with the vaginal administration of PGE2 gel (first dose: 1 mg, second dose 1 or 2 mg, six hours later). The success rate of both techniques is comparable, approximately 70 p. cent. Also, the times between amniotomy and delivery are identical, approximately 5 hours. On the contrary, the lapses of time between the onset of the induction and the delivery, vary significantly, being always longer in the PGE2 group. However, the dose of vaginal PGE2 gel as well as the time of artificial membrane rupture could be modified in order to decrease the delay of the effect.
PGE2 increases successful vaginal delivery rates in 24 hours and cervical favourability with no increase in operative delivery rates. Sustained release vaginal PGE2 is superior to vaginal PGE2 gel with respect to some outcomes studied.
Further research is needed to assess the best vehicle for delivering vaginal prostaglandins and this should, where possible, include some examination of the cost-analysis.
[Note: The 10 citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]