A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis

doi:10.1016/0002-9378(91)90456-2

American Journal of Obstetrics and Gynecology

Volume 165, Issue 4, Part 1, October 1991, Pages 991-996

https://doi.org/10.1016/0002-9378(91)90456-2 Get rights and content

Abstract

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.

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Cited by (53)

Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis
2010, American Journal of Obstetrics and Gynecology
Citation Excerpt :
Sensitivity analyses were performed by the sequential omission of each study and an analysis the overall impact on the pooled results. We identified 27 studies that assessed effectiveness of 10-mg dinoprostone vaginal inserts for cervical ripening and labor induction,3-23,29-36 16 of which were excluded (Figure): 1 study because it was a noncomparative surveillance study that reported the experience at a community hospital;29 2 studies because they were basic science research studies that assessed pharmacokinetics of the vaginal inserts;30,31 6 studies because they compared dinoprostone with prostaglandins other than misoprostol;6-8,11-13 3 studies because the type of pessary used was distinct from the controlled-release vaginal insert;32-34 1 study because a misoprostol vaginal insert was used rather than an intravaginal tablet,22 and the last 3 studies because the vaginal insert was compared with placebo.3-5 Eleven randomized clinical trials that compared the 10-mg, sustained-release dinoprostone vaginal insert with vaginal misoprostol tablets for cervical ripening and labor induction were evaluated further.
The purpose of this study was to review randomized trials that compared the efficacy of the dinoprostone 10-mg controlled-release vaginal insert with that of vaginally administered misoprostol tablets in cervical ripening and labor induction.
Electronic databases were used to identify randomized clinical trials that compared dinoprostone with misoprostol. Estimates of the relative risk for individual studies and risk difference from dichotomous outcomes with the use of random and fixed-effects models were calculated.
Women who received misoprostol had a higher incidence of vaginal delivery within 12 and 24 hours of prostaglandin application, compared with dinoprostone. Both modalities had similar incidences of cesarean delivery, uterine hyperstimulation, and fetal tachysystole. There was an increased need for oxytocin augmentation in the dinoprostone group. No significant difference in neonatal outcomes was noted between the 2 groups.
Vaginally administered misoprostol was more effective than the dinoprostone vaginal insert for cervical ripening and labor induction. The safety profiles of both drugs were similar.
Management of pregnancies beyond forty-one week's gestation with an unfavorable cervix
2005, Revue Sage - Femme
On se propose de déterminer le protocole le plus optimal de prise en charge des grossesses prolongées au-delà de 41 SA avec un col défavorable pour le déclenchement, en comparant la surveillance par des RCF jusqu’à 42 SA à la maturation cervicale par un gel de Prépidil^® à partir de 41 SA.
Nous avons mené un essai clinique prospectif randomisé qui a débuté le 1^er mai 2002 et s’est achevé le 30 mars 2003. Toutes les grossesses non compliquées répondant aux critères d’inclusion, qui atteignent 41 SA avec un score de Bishop inférieur à 4 était randomisées en deux groupes: 1. surveillance par des RCF un jour sur deux jusqu’à 42 SA ; 2. maturation cervicale par un gel de Prépidil^® à partir de 41 SA qui peut être renouvelée après 24 heures, si non amélioration du score de Bishop, avec un maximum de 3 doses.
L’analyse des résultats a mis en évidence : une réduction de la durée totale du travail (p = 0,002) dans le groupe « Prépidil », 40 % des patientes dans le groupe « surveillance » n’étaient pas entrées en travail jusqu’à 42 SA nécessitant ainsi une maturation cervicale, le mode d’accouchement est comparable dans les deux groupes, pas de différences significatives dans le taux de mortalité et de morbidité néonatale, ni pour le taux d’admission dans une unité de soins intensifs.
Au terme de ce travail, nous recommandons une maturation cervicale par un gel de Prépidil^® systématique à partir de 41 SA.
Our purpose was to determine the optimal management of pregnancies beyond 41 week's gestation with a cervix unfavorable for induction.
All uncomplicated pregnancies that reached 41 weeks’gestation with a Bishop score of ≤ 4, were randomly assigned to one of two groups: 1. Serial antenatal surveillance until 42 weeks while awaiting spontaneous labor; 2. Daily cervical ripening by prostaglandin gel, maximum three gels.
The duration of labor was shorter in the group “prépidil” compared with the control group (P=0.002). Identification of an unfavorable cervix at 41 weeks was unlikely to change by 42 weeks and cervical ripening was required in 40% cases. There was no significant difference in caesarean section rates. Rates of admission into the neonatal unit and fetal outcomes were similar in the two groups.
Cervical ripening with prostaglandin gel at 41 week's gestation for uncomplicated singleton pregnancies is safe and should be advocated.
Management of pregnancies beyond forty-one week's gestation with an unfavorable cervix
2005, Journal de Gynecologie Obstetrique et Biologie de la Reproduction
On se propose de déterminer le protocole le plus optimal de prise en charge des grossesses prolongées au-delà de 41 SA avec un col défavorable pour le déclenchement, en comparant la surveillance par des RCF jusqu’à 42 SA à la maturation cervicale par un gel de Prépidil^® à partir de 41 SA.
Nous avons mené un essai clinique prospectif randomisé qui a débuté le 1^er mai 2002 et s’est achevé le 30 mars 2003. Toutes les grossesses non compliquées répondant aux critères d’inclusion, qui atteignent 41 SA avec un score de Bishop inférieur à 4 était randomisées en deux groupes
- 1.
  surveillance par des RCF un jour sur deux jusqu’à 42 SA maturation cervicale par un gel de Prépidil^® à partir de 41 SA.
- 2.
  qui peut être renouvelée après 24 heures, si non amélioration du score de Bishop, avec un maximum de 3 doses.
L’analyse des résultats a mis en évidence : une réduction de la durée totale du travail (p = 0,002) dans le groupe « Prépidil », 40 % des patientes dans le groupe « surveillance » n’étaient pas entrées en travail jusqu’à 42 SA nécessitant ainsi une maturation cervicale, le mode d’accouchement est comparable dans les deux groupes, pas de différences significatives dans le taux de mortalité et de morbidité néonatale, ni pour le taux d’admission dans une unité de soins intensifs.
Au terme de ce travail, nous recommandons une maturation cervicale par un gel de Prépidil^® systématique à partir de 41 SA.
Our purpose was to determine the optimal management of pregnancies beyond 41 week's gestation with a cervix unfavorable for induction.
All uncomplicated pregnancies that reached 41 weeks’gestation with a Bishop score of ≤ 4, were randomly assigned to one of two groups
- 1.
  Serial antenatal surveillance until 42 weeks while awaiting spontaneous labor.
- 2.
  Daily cervical ripening by prostaglandin gel, maximum three gels.
The duration of labor was shorter in the group “prépidil” compared with the control group (P=0.002). Identification of an unfavorable cervix at 41 weeks was unlikely to change by 42 weeks and cervical ripening was required in 40% cases. There was no significant difference in caesarean section rates. Rates of admission into the neonatal unit and fetal outcomes were similar in the two groups.
Cervical ripening with prostaglandin gel at 41 week's gestation for uncomplicated singleton pregnancies is safe and should be advocated.
Induction of labor
2005, Obstetrics and Gynecology Clinics of North America
Cervical ripening with oral misoprostol at term
2003, International Journal of Gynecology and Obstetrics
Objectives: To determine the efficacy of 200 μg single dose oral misoprostol as a cervical priming agent at term. Methods: In this double-blind randomized trial, 156 pregnant women requiring induction of labor with gestational age of 37–42 weeks and Bishop score ≤5, were randomized to receive either 200 μg of misoprostol or a placebo, orally. Labor was induced with intravenous oxytocin infusion 12 h after oral medication if the patient did not go into labor. The primary outcome was the change in the Bishop score 12 h after oral medication. The secondary outcomes were the timings starting from the drug administration to the onset of uterine activity, interval between oral medication and delivery, oxytocin need for induction, mode of delivery, frequency of side effects, and neonatal and maternal outcome. The chi-square or Fisher exact test, Student's t-test, and Mann–Whitney U-test were used for analysis of the data. Results: There were no significant differences in maternal characteristics or indications of induction. The Bishop score 12 h after oral medication significantly improved in the misoprostol group compared with the control group [55 (70%)>8 vs. 4 (5%)>8; P<0.001]. The induction rate was significantly reduced in the misoprostol group (P<0.001). The interval between oral medication and the onset of uterine activity was significantly shorter in the misoprostol group (P<0.001). The interval between oral medication and delivery was also significantly shorter in the misoprostol group (P<0.001). The cesarean delivery rate was significantly lower in the misoprostol group (P<0.001). There were no differences between the groups with respect to the incidence of tachysystole, hyperstimulation, adverse neonatal or maternal outcome. Conclusions: Oral administration of 200 μg single dose of misoprostol is an effective agent not only for cervical priming but also for induction of labor at term. Furthermore, it reduces the rate of cesarean deliveries.
Oral versus vaginal misoprostol for induction of labor: A double-blind randomized controlled trial
2001, American Journal of Obstetrics and Gynecology
Objective: To determine the efficacy of oral misoprostol (50 μg) administered every 3 hours compared to vaginal misoprostol (50 μg) administered every 6 hours for induction of labor. Study Methods: In this double-blind randomized trial, 126 women received misoprostol (50 μg) either orally every 3 hours or vaginally every 6 hours for induction of labor. Outcomes included time from induction to delivery, oxytocin augmentation, incidence of hyperstimulation and tachysystole, mode of delivery, and neonatal outcomes. Results: Median time to delivery was shorter in those women who were receiving vaginal misoprostol (vaginal 14.3 hours vs oral 23.1 hours; P =.0004) and more women in the oral group required oxytocin augmentation of labor (73% vs 42%)(RR, 1.98; 95% CI, 1.29 to 3.06). The incidence of hyperstimulation was similar between the groups, but there was an increased incidence of tachysystole in the vaginal group (26.5% vs 9.7%)(RR, 2.74; 95% CI, 1.16 to 6.51). There was no difference between the groups with respect to mode of delivery or neonatal outcome. Conclusion: Vaginal misoprostol administered every 6 hours is more effective for induction of labor than oral misoprostol administered every 3 hours. The higher rates of tachysystole with use of vaginal misoprostol in the current study warrant further investigation. (Am J Obstet Gynecol 2001;185:906–10.)

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: Presented at the Eleventh Annual Meeting of the Society of Perinatal Obstetricians, San Francisco, California, January 28-February 2, 1991.

^*: From the Division of Maternal and Fetal Medicine, Department of Obstetrics and Gynecology, and the Center for Nursing Research, University of Alabama at Birmingham.

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A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis

Abstract

Am J Obstet Gynecol

Psychol Bull

Am J Obstet Gynecol

Pelvic scoring for elective induction

Obstet Gynecol

A double-blind controlled trial of PGE2 gel in cervical ripening

Int J Gynaecol Obstet

Preinduction cervical ripening with prostaglandin E2 intracervical gel

Obstet Gynecol

A comparison of PGE2 vaginal gel for ripening the cervix before induction of labour

Br J Obstet Gynaecol

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

J Perinatol

A randomized, double-blind trial of prostaglandin E₂ gel for cervical ripening and meta-analysis

A double-blind controlled trial of PGE₂ gel in cervical ripening

Preinduction cervical ripening with prostaglandin E₂ intracervical gel

A comparison of PGE₂ vaginal gel for ripening the cervix before induction of labour

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