Cervical priming with oral misoprostol in pre-labor rupture of membranes at term

doi:10.1016/0029-7844(96)00072-5

Obstetrics & Gynecology

Volume 87, Issue 6, June 1996, Pages 923-926

https://doi.org/10.1016/0029-7844(96)00072-5 Get rights and content

Objective

To investigate the effectiveness of oral misoprostol as a cervical priming agent for patients presenting with pre-labor rupture of membranes at term.

Methods

Eighty patients presenting with pre-labor rupture of membranes at term were randomized to receive either 200 μg of misoprostol or 50 mg of vitamin B₆ orally 1 hour after admission. Labor was induced with intravenous oxytocin infusion 12 hours after oral medication if the patient did not go into labor. We compared the induction rate, duration of labor, mode of delivery, and leaking-to-delivery interval in the two groups.

Results

The cervical score was significantly improved and the induction rate was also reduced in the misoprostol group when compared with the control group. The interval from recruitment to onset of labor, duration of labor, and the interval from recruitment to delivery were significantly shorter in the misoprostol group. The mode of delivery and the perinatal outcome were similar for the two groups.

Conclusion

Oral misoprostol is an effective agent for cervical priming and labor induction in patients with prelabor rupture of membranes at term.

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Cited by (97)

Oral Misoprostol for Induction of Labour in Term PROM: A Systematic Review
2020, Journal of Obstetrics and Gynaecology Canada
Citation Excerpt :
Overall, 49 unique articles were identified, of which 27 met the criteria for full-text review. Twelve randomized controlled trials,13–24 including 1489 singleton pregnancies, addressed the comparison of varying doses of oral misoprostol with other induction methods (Foley catheter, PGE2 gel, oxytocin infusion) or placebo/expectant management and were included in the review (Figure 1). Of 1485 participants, 924 (63.9%) were primiparous.
To assess the efficacy of oral misoprostol for induction of labour (IOL) in the context of term pre-labour rupture of membranes (TPROM), and to assess pregnancy outcomes following the administration of oral misoprostol.
A systematic literature search was performed using Ovid Medline, Embase, PubMed, and the Cochrane Database of Systematic Reviews.
Eligible studies were quasi-experimental trials or randomized controlled trials involving the use of oral misoprostol in singleton cephalic term pregnancies with confirmed rupture of membranes and no spontaneous labour at the time of membranes rupture, in mothers with no contraindications to vaginal delivery. Studies were excluded if they utilized vaginal misoprostol, excluded primigravid participants, or if the full text of the article was not accessible in English.
Data were extracted by two reviewers using a standardized data extraction form. Study quality was assessed using the modified Jadad score.
Twelve randomized controlled trials that included 1489 singleton pregnancies were included. Doses of oral misoprostol ranged from 20 to 200 μg. The incidence of vaginal birth ranged from 73.0%–95.0% in the oral misoprostol group compared with 52.4%–94% in the control group. Hyperstimulation was infrequent, ranging from 0% to 13.8% in the oral misoprostol group compared with 0%–24% in the control group. Two trials, involving a total of 144 women that compared 50 μg of oral misoprostol every 4 hours versus expectant management followed by PGE₂ gel showed a higher incidence of vaginal birth with misoprostol (pooled risk ratio 1.33, 95% confidence interval 1.10–1.61).
Oral misoprostol appears to be a safe and effective for IOL in TPROM. However, the varying administration, dose, and frequency reported in the literature highlights the need to develop a standardized protocol for use in Canadian obstetrical practice.
Évaluer l'efficacité du misoprostol par voie orale pour le déclenchement artificiel du travail (DAT) dans un contexte de rupture prématurée des membranes à terme (RPMT) et évaluer les issues de grossesse après l'administration de misoprostol par voie orale.
Une recherche documentaire systématique a été effectuée dans les bases de données Ovid Medline, Embase, PubMed et Cochrane Database of Systematic Reviews.
Les études admissibles étaient des essais quasi-expérimentaux ou des essais cliniques randomisés portant sur le misoprostol par voie orale en cas de grossesse monofœtale à terme avec présentation céphalique et rupture confirmée des membranes, sans travail spontané lors de la rupture, chez des mères qui ne présentaient aucune contre-indication à l'accouchement vaginal. Les auteurs ont exclu les études qui portaient sur l'administration de misoprostol par voie vaginale, qui excluaient les participantes primigestes et les études dont le texte intégral de l'article n’était pas accessible en anglais.
Deux évaluateurs ont extrait les données à l'aide d'un formulaire d'extraction de données normalisé. La qualité des études a été évaluée au moyen des scores de l’échelle de Jadad modifiée.
Douze essais cliniques randomisés totalisant 1 489 grossesses monofœtales ont été inclus. Les doses de misoprostol administrées par voie orale variaient de 20 à 200 μg. L'incidence de l'accouchement vaginal variait de 73,0 % à 95,0 % dans le groupe du misoprostol par voie orale, comparativement à un taux de 52,4 % à 94 % dans le groupe témoin. L'hyperactivité utérine était peu fréquente, allant de 0 % à 13,8 % dans le groupe du misoprostol par voie orale, comparativement à un taux de 0 % à 24 % dans le groupe témoin. Deux essais réalisés auprès de 144 femmes ont comparé l'administration d'une dose 50 μg de misoprostol par voie orale toutes les 4 heures à la prise en charge non interventionniste suivie de l'application de gel de PGE₂; les essais ont indiqué une incidence plus élevée de l'accouchement vaginal avec l'administration de misoprostol (risque relatif global : 1,33; intervalle de confiance de 95 % : 1,10–1,61) en comparaison avec la prise en charge non interventionniste.
Le misoprostol par voie orale semble être sécuritaire et efficace pour le DAT en cas de RPMT. Toutefois, les différences rapportées dans la littérature relativement à l'administration, la dose et la fréquence mettent en lumière la nécessité de mettre au point un protocole normalisé pour l'administration de misoprostol par voie orale dans la pratique obstétricale canadienne.
Labor induction in the patient with preterm premature rupture of membranes
2015, Seminars in Perinatology
Citation Excerpt :
A 1977 study of 100 patients with term PROM found that oral PGE2 was safe and effective and conferred a shorter latency from PROM to delivery.27 Since this trial, multiple studies have reported conflicting data that consistently support the use of prostaglandins as safe and effective in the patient with PROM, but differ with regard to prostaglandins superiority to oxytocin.28–33 Butt et al.28 report in their well-designed randomized controlled trial of 108 women with term PROM that although the time spent in active labor as well as maternal and neonatal outcomes were similar, oxytocin conveyed a shorter interval to delivery time by greater than 3 h when compared to prostaglandin.
Preterm premature rupture of membranes (PPROM) affects up to one-third of all preterm births and confers serious maternal risks, including intra-amniotic infection, and an increased risk of neonatal complications, including respiratory distress and intraventricular hemorrhage. Management of PPROM is a highly individualized process that requires an accurate determination of gestational age and causal factors, as well as the balancing of maternal and fetal risks. In this review of the existing literature on induction of labor in PPROM, we examine the differences in appropriate management of patients with early (32 weeks 0 days to 33 weeks 6 days) and near term (34 weeks 0 days to 36 weeks 6 days) PPROM, and compare the safety and efficacy of available treatment options. This review of previous research findings provides general guidelines for clinical decision making and highlights the need for future research on management of PPROM.
Comparative Evaluation of 50 Microgram Oral Misoprostol and 25 Microgram Intravaginal Misoprostol for Induction of Labour at Term: A Randomized Trial
2013, Journal of Obstetrics and Gynaecology Canada
To assess and compare the efficacy and safety of 50 μg oral misoprostol and 25 μg intravaginal misoprostol for induction of labour at term.
This non-blinded, randomized clinical trial included 228 pregnant women at term with obstetric or medical indications for induction of labour. Women either took 50 μg misoprostol orally (two 25 μg tablets) or had one 25 μg tablet of misoprostol inserted in the posterior vaginal fornix. In each group, misoprostol administration was repeated every four hours in the same dose until regular uterine contractions were established or to a maximum of five doses. Time to delivery and outcome data for each group were compared.
Of the 228 women, eight (3.5%) were excluded from the analysis as they withdrew their consent after randomization. Mean induction-to-delivery interval was similar in both groups (21.22 hours in the oral group vs. 20.15 hours in the vaginal group; P = 0.58). There was no significant difference between the groups with respect to the number of women who delivered within 24 hours or who required oxytocin augmentation of labour, the mode of delivery, and neonatal outcomes (P > 0.05). Uterine hyperstimulation occurred in two women who received misoprostol vaginally, but not in any of the women in the oral misoprostol group.
Oral misoprostol in a dose of 50 μg every four hours, to a maximum of five doses, has the potential to induce labour as safely and effectively as 25 μg misoprostol administered vaginally every four hours.
Évaluer et comparer l’efficacité et l’innocuité de 50 μg de misoprostol par voie orale et de 25 μg de misoprostol par voie intravaginale pour le déclenchement du travail à terme.
Cet essai clinique randomisé n’ayant pas été mené à l’insu portait sur 228 femmes enceintes à terme qui présentaient des indications obstétricales ou médicales en ce qui concerne le déclenchement du travail. Ces femmes ont été affectées au hasard à un groupe devant prendre 50 μg de misoprostol par voie orale (deux comprimés de 25 μg) ou à un groupe devant se faire insérer un comprimé de 25 μg de misoprostol dans le cul-de-sac postérieur du vagin. Dans chacun de ces groupes, l’administration de la même dose de misoprostol a été répétée toutes les quatre heures jusqu’à ce que des contractions utérines régulières aient été établies ou jusqu’à l’administration d’un maximum de cinq doses. Le délai jusqu’à l’accouchement et les données quant aux issues ont été comparés chez ces groupes.
Huit (3,5 %) de ces 228 femmes ont été exclues de l’analyse puisqu’elles ont révoqué leur consentement à la suite de la randomisation. L’intervalle déclenchement-accouchement moyen était semblable dans les deux groupes (21,22 heures au sein du groupe « oral » vs 20,15 heures au sein du groupe « vaginal »; P = 0,58). Aucune différence significative n’a été constatée entre les deux groupes en ce qui concerne le nombre de femmes ayant accouché dans les 24 heures ou ayant nécessité une accélération du travail à l’oxytocine, le mode d’accouchement et les issues néonatales (P > 0,05) Une hyperstimulation utérine s’est manifestée chez deux des femmes qui avaient reçu du misoprostol par voie vaginale; toutefois, aucune des femmes ayant reçu du misoprostol par voie orale n’a été affectée par un tel phénomène.
Le misoprostol administre par voie orale à raison de 50 μg toutes les quatre heures, jusqu’à un maximum de cinq doses, présente le potentiel de déclencher le travail de façon tout aussi sûre et efficace que le misoprostol administré par voie vaginale à raison de 25 μg toutes les quatre heures.
Misoprostol for term labor induction: A randomized controlled trial
2011, Taiwanese Journal of Obstetrics and Gynecology
The aim of this study was to compare the efficacy of vaginal misoprostol with vaginal dinoprostone for term labor induction.
It was a randomized controlled trial done in the Obstetrics Department, Shifa Community Health Centre, Shifa International Hospital (Teaching Hospital of Shifa College of Medicine, Islamabad). All pregnant women at term pregnancy coming for induction of labor were enrolled. 246 women fulfilled the inclusion criteria. Out of them 208 women consented to be part of the study. These women were then randomized to receive either Treatment A (vaginal misoprostol) or Treatment B (vaginal dinoprostone). Data were completed for 200 women. These included induction labor and induction-delivery interval, fetal and maternal complications, and baby apgar score.
Out of 200 women in the study, 100 were in Group A and 100 in Group B. Labor commenced in a mean of 6.67 hours (±3.63) in Group A whereas it took a mean of 8.41 hours (±5.13) in Group B (p = 0.00). Actual induction to delivery (of the baby) interval was a mean of 11.68 hours (±4.55) for misoprostol and 15.37 hours (±5.30) for dinoprostone group (p = 0.00). There were no cases of uterine rupture in both groups; however, there were 10 cases of uterine hyperstimulation in Group A and 4 in Group B (p = 0.09).
It is time to re-evaluate the role of misoprostol for term labor induction. It is an efficacious and cost-effective alternative to the presently licensed treatment.
Oral misoprostol versus intracervical prostaglandin E2 gel for active management of premature rupture of membranes at term
2009, International Journal of Gynecology and Obstetrics
To compare the efficacy and safety of oral misoprostol with intracervical prostaglandin E2 (PGE2) gel for the active management of premature rupture of membranes (PROM) at term.
Women with pregnancies between 37 and 42 weeks presenting with PROM at term and a Bishop score of 5 or less were randomly assigned to receive either a 4-hourly oral dose of 50 µg of misoprostol up to a maximum of 3 doses or 2 applications of intracervical PGE2 gel at a 6-hour interval. Oxytocin was given if labor had not started after 12 hours.
Twenty women in the misoprostol group (n = 31) delivered within 12 hours compared with 5 in the PGE2 group (n = 30) (P < 0.001). The induction-to-delivery interval in the misoprostol group was shorter than in the PGE2 gel group (615 min vs 1070 min; P < 0.001). The mode of delivery was comparable between the 2 groups (P = 0.821). Abnormalities in uterine contractions and neonatal outcomes were also comparable. The requirement for oxytocin was lower and patient satisfaction was better in the misoprostol group.
Oral misoprostol is a safe and efficacious alternative to intracervical PGE2 gel in the active management of PROM at term.
Pre-labor rupture of membranes at term in patients with an unfavorable cervix: Active versus conservative management
2008, Taiwanese Journal of Obstetrics and Gynecology
To compare the safety and efficacy of conservative management of pre-labor rupture of membranes (PROM) at term in patients with an unfavorable cervix, with active treatment using oral misoprostol.
This quasi-experimental study was conducted between June 1, 2004 and November 30, 2004 at Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eighty-four multigravid women (parity, < 5) at ≥37 weeks' gestation and with unfavorable cervices were divided equally between group S (study) and group C (conservative). Group S was given 50 μg of oral misoprostol every 4 hours for a maximum of four doses, while group C was managed conservatively. The intervals between PROM and significant uterine contractions and delivery, the mode of delivery, and maternal and fetal/neonatal complications were the main outcome measures.
The intervals between PROM and the onset of uterine contractions and delivery were lower in group S than group C (9.6 vs. 14.8 hours; p< 0.001) and (11.6 vs. 17 hours; p < 0.001), respectively. Fewer women delivered abdominally within 24 hours of PROM in group S than in group C (5% vs. 24%; p < 0.05). Induction failure in group S was less than conservative management failure in group C (10% vs. 60%; p < 0.001). The maternal complication rate was less in group S than in group C (7% vs. 14%;p > 0.05), but the fetal/neonatal complication rate was similar in both groups (5%).
Oral misoprostol (50 μg) is safe and effective for cervical ripening and labor induction in patients with PROM and an unfavorable cervix. [Taiwan J Obstet Cynecol 2008;47(2):1 92-1 96]

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Cervical priming with oral misoprostol in pre-labor rupture of membranes at term

Objective

Methods

Results

Conclusion

Am J Obstet Gynecol

Am J Obstet Gynecol

Contraception

Am J Obstet Gynecol

Management of premature rupture of the membranes

Obstet Gynecol

Management of term patients with premature rupture of membranes and an unfavorable cervix

Am J Perinatol

Management of prelabor rupture of membranes at term. A randomised study

Acta Obstet Gynecol Scand

Premature rupture of membranes at term

J Reprod Med

Stimulation of labor in cases of premature rupture of the membranes at or near term

Acta Obstet Gynecol Scand