Preinduction cervical ripening with prostaglandin E2 intracervical gel

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.     

Induction of labor and cervical ripening by intracervical prostaglandin E2

A randomized double-blind trial was conducted over 48 hours comparing the effectiveness of prostaglandin E2 gel administered intracervically with that of demoxytocin buccal tablets for induction of labor in 103 patients with unripe cervical status (Bishop score 5 or less). A statistically significant difference was found in success frequency between the two groups, both on the first day (54.7 and 34.0%, respectively) and on the second day (82.0 and 61.9%, respectively; P less than .05). Without being matched, variables influencing the course of labor in the two groups were comparable. There was no statistically significant difference in the induction-delivery interval between the two groups during the first and second days of the trial. In both the prostaglandin E2 and the demoxytocin groups, patients who had not gone into labor during the first day showed a statistically significant increment in the Bishop score on the morning of the second day (2.4 and 1.3, respectively; P less than .01). The frequency of instrumental deliveries and cesarean section was the same in both groups; neither hypertonic uterine contractions nor side effects were observed in any patient. It is concluded that prostaglandin E2 gel administered intracervically is particularly well suited for the induction of labor in patients with unripe cervical status because of its combined contraction-inducing and cervical-ripening properties.     

Sweeping of membranes vs. intracervical prostaglandin E2 gel for cervical ripening. Randomized trial

OBJECTIVE: To compare intracervical prostaglandin E2 gel and membrane sweeping for cervical ripening. STUDY DESIGN: Fifty patients were randomized to either intracervical prostaglandin E2 or membrane sweeping. A Bishop score was assigned by a blinded examiner prior to and 24 hours following the procedure. RESULTS: The Bishop scores assigned 24 hours after prostaglandin instillation and membrane sweeping were not significantly different (3.4, SE 0.42, vs. 3.3, SE 0.37, respectively; P > .05). The proportions of women entering active labor or delivering within 24 hours were similar in the prostaglandin and membrane groups (21% and 19%, respectively; P > .05). CONCLUSION: When both intracervical prostaglandin insertion and membrane sweeping are feasible, their salutary effects are comparable.     

Pre-induction cervical ripening with prostaglandin E2 gel: intracervical versus intravaginal route

The aim of our study was to evaluate the best method for cervical ripening before a classical induction with amniotomy and oxytocin. One hundred term pregnant patients who presented an unfavorable cervix and an indication for the induction of labor were assigned randomly to either 0.5 mg prostaglandin (PG) E2 gel intracervically (N = 52) or 3 mg PGE2 gel intravaginally (N = 48). The intravaginal gel had a greater effect on cervical ripening according to a modification of the Bishop score than did intracervical gel, but it had a higher incidence of side effects.     

Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening

BACKGROUND: The success of induced labor depends on the degree of ripening of cervix. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study has been conducted to prove the efficacy and safety of extraamniotic Foley catheter balloon and to compare it with intracervical prostaglandin E2 (PGE2) gel. METHODS: The randomized prospective study was conducted in the Department of Obstetrics and Gynecology and Medical Microbiology of Nehru Hospital. Hundred women attending the labor ward for induction of labor were divided into two groups: Group A--Foley catheter, Group B--PGE2 gel. Cervical swabs before and after the insertion of ripening agents were taken for culture studies. Placental membranes were also sent for culture. Labor outcome, side-effects, and complications were compared in both the groups. The statistical methods used were Student's compared t-test, Chi-square test, and Wilcoxon-Mann-Whitney test. RESULTS: Foley catheter proved to be a very effective preinduction ripening agent for unfavorable cervix compared with PGE2 gel, as is evident by the mean Bishop score at 12 h (P<0.001). Preparation delivery interval was significantly shorter (P<0.05) in women who underwent cervical ripening with Foley catheter balloon than with the PGE2 gel. No clinical evidence of chorioamnionitis was present in both the groups. CONCLUSION: This study concludes that extraamniotic Foley catheter balloon is an effective, safe, simple, low-cost, reversible, non-pharmacological mechanical method of preinduction cervical ripening.     

Open randomized comparison of prostaglandin E2 given by intracervical gel or vagitory for preinduction cervical ripening and induction of 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.     

Plasma prostaglandin metabolite levels after use of prostaglandin E2 gel for cervical ripening

An ideal agent for cervical ripening should produce an increase in cervical scores without stimulating myometrial contractions. Currently used methods of preinduction ripening with prostaglandin E2 are frequently associated with contractions, limiting their use in high-risk patients. To discriminate between a direct effect of absorbed prostaglandin E2 and a triggering of the intrinsic mechanisms of labor, we measured circulating levels of stable metabolites of prostaglandin E2 and prostaglandin F2 alpha. Prostaglandin E2 gel insertion followed by a rise in prostaglandin E2 metabolite but not prostaglandin F2 alpha metabolite implies that contractions are secondary to absorbed prostaglandin E2.     

Outpatient cervical ripening using a sustained-release prostaglandin E2 vaginal insert.

This clinical trial was undertaken to determine whether a sustained-release prostaglandin E2 vaginal insert could be used for outpatient cervical ripening. A total of 111 patients, with primarily pregnancy-induced hypertension or postdatism, were administered the insert in a simulated outpatient setting. The high rates of regular contractions (23.4%) and of removal of the insert before < 12 hours (27.9%) make its use undesirable outside a hospital.     

Use of prostaglandin E2 for cervical ripening in pregnancies with oligohydramnios

The effectiveness of intracervical prostaglandin E2 (PGE2) was studied in 96 primigravidas with unfavorable cervix and need for induction of labor. Group A consisted of 49 oligohydramnios and group B of 47 cases with normal amniotic fluid volume (controls). A single dose of 0.5 mg PGE2 gel was applied intracervically and several parameters were recorded during the next hours. The mean number of uterine contractions increased during the first 2 h in both groups, decreased during the next one and did not change significantly afterwards. The mean fetal heart rate (FHR) in group A decreased during the first 2 h and then increased, staying always within normal limits. The mean FHR in group B increased for 2 h, decreased during the next hour and did not change significantly afterwards. No significant differences were found between the two groups regarding mode of delivery, Apgar score and neonatal acidosis. Intracervical PGE2 appeared to effectively stimulate cervical ripening and labor induction in oligohydramnios, without causing side effects to the uterus and fetus.     

Cervical ripening and labor outcome with preinduction intracervical prostaglandin E2 (Prepidil) gel

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.     

Influence of vehicle form on efficiency of prostaglandin E2 gel for cervical ripening.

A double-blind randomized controlled trial compared the efficiency of prostaglandin E2 (PGE2) gel in two different vehicle forms, one solid and the other more liquid, with respect to inducing labour in women with highly unfavourable cervical states. 43 received 0.5 mg PGE2 in a solid gel (Cerviprost) and 37 received 0.5 mg PGE2 in a more liquid cellulose-gel. After one application 18 (42%) and 9 (24%), respectively, went into labour (OR 2.8; 95% confidence interval: 0.8-6.0). After two applications of the gel 91 and 76%, respectively, were in active labour or had amniotomy performed as the cervical state had improved (OR 2.9; 95% confidence interval: 0.8-10.3). It is concluded that the solid gel was more efficient and safe than the more liquid gel.     

Intracervical prostaglandin E2 gel. Safety for outpatient cervical ripening before induction of labor.

Cervical ripening prior to induction of labor is often necessary for medical complications of pregnancy. We proposed to prospectively determine the safety of administering prostaglandin E2 (PGE2) gel intracervically in an outpatient setting. Four hundred forty-six patients underwent 515 gel procedures as outpatients. Trained perinatal nurses placed 0.5 mg of PGE2, prepared in a standard methylcellulose base, in the intracervical canal. The PGE2 dose was administered every two hours for a total of three doses if labor did not start. The patient was sent home two hours after the last dose if she was not in active labor. Labor started in 90 patients (20%) during the gel procedure; they were admitted to the labor-and-delivery unit. The remaining patients were discharged. Eighty-eight patients (20%) were later admitted in active labor prior to scheduled induction. One patient (0.02%) was found to have occasional prolonged decelerations on admission and underwent a cesarean section two hours after admission; the Apgar scores were 8 and 9 and the arterial pH, 7.21. Hyperstimulation with excessive intrauterine activity caused significant deceleration of the fetal heart rate in four patients (0.8%), two of whom required transfer to the labor-and-delivery unit but none of whom needed a cesarean section for fetal distress. PGE2 gel can be administered safely intracervically as an outpatient procedure by trained perinatal nurses.     

A comparison of prostaglandin E2 gel and prostaglandin F2 alpha gel for preinduction cervical ripening

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.     

Preinduction cervical ripening with sequential use of prostaglandin E2 gel

Two hundred patients received a prostaglandin E2-containing gel for preinduction cervical ripening. The gel was administered every 6 hours until a Bishop score greater than or equal to 7 was obtained or the attending physician deemed induction necessary. Forty-eight percent of the patients labored "spontaneously" after one or more gel applications. The average cumulative change in Bishop score with sequential application of the gel was 2.7. Sequential application of the prostaglandin gel proved no more effective in the process of preinduction cervical ripening than single application of the gel with a similar period of observation.     

Oral misoprostol vs. intravaginal prostaglandin E2 for preinduction cervical ripening. A randomized trial

OBJECTIVE: To compare orally administered misoprostol with intravaginal prostaglandin E2 for cervical ripening and labor induction. STUDY DESIGN: Patients presenting with medical or obstetric indications for labor induction whose Bishop's score was < or = 6 were randomly allocated to receive either 50 micrograms of oral misoprostol or 4 mg of intravaginal prostaglandin E2. If adequate cervical ripening (Bishop score of 9 or cervical dilatation of 3) or active labor did not ensue, repeat doses of each medication were administered every four hours. A maximum of six doses of either oral misoprostol or intravaginal prostaglandin E2 was permitted. Intravenous oxytocin was subsequently administered according to a standardized infusion protocol. RESULTS: Sixty patients were enrolled, with 29 randomized to the oral misoprostol arm and 31 to the prostaglandin E2 group. The data on 58 patients were eligible for analysis. Delivery occurred within 48 hours in 96.4% (27/28) of those administered oral misoprostol as compared to 76.7% (23/30) of those who received intravaginal prostaglandin E2 (P = .03). The mean time intervals from the start of induction to delivery were similar between the two groups (1,496 +/- 120 vs. 1,723 +/- 230 minutes, P = .40). No statistically significant differences existed between the two groups with respect to intrapartum complications, tachysystole, uterine hyperstimulation or adverse neonatal outcomes. CONCLUSION: Oral administration of misoprostol is an effective alternative to intravaginal prostaglandin E2 for preinduction cervical ripening.     

Preinduction cervical ripening with prostaglandin E2 (Prepidil) gel

The effect of preinduction cervical ripening with Prepidil, a commercially prepared prostaglandin E2 gel (0.5 mg), on the outcome of induction of labor with intravenous oxytocin was investigated. Fifty-nine pregnant women were randomized either to receive intracervical application of the gel or to undergo sham application. Compared to control subjects, patients in the group given Prepidil had significant increases in cervical Bishop scores, shorter induction-to-delivery intervals, lower maximum doses of oxytocin, and fewer days of induction. Systemic side effects were minimal, but 37% (11 of 30) of the gel-treated patients experienced labor prior to receiving oxytocin and 20% (six of 30) were actually delivered during the 12-hour ripening period. No differences in route of delivery or fetal outcome were found between the two groups.     

Hygroscopic cervical dilators and prostaglandin E2 gel for preinduction cervical ripening. A randomized, prospective comparison.

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.     

Variations of biologic activity of low-dose prostaglandin E2 on cervical ripening

The effect of low-dose prostaglandin E2 vaginal gel specially prepared from commercially available materials, on subsequent indicated oxytocin induction of labor, was investigated in a randomized, double-blind, placebo-controlled clinical trial. The stability of the gel after preparation was documented by radioimmunoassay in vitro. No differences between the treated and placebo groups were noted in subsequent modified Bishop scores, length of labor, use of analgesia or anesthesia, success of induction, mode of delivery, or perinatal outcome. Comparisons of this clinical trial with those previously reported are offered.