A Randomized Clinical Trial Comparing Vaginal Misoprostol versus Cervical Foley Plus Oral Misoprostol for Cervical Ripening and Labor Induction

Abstract Background: Being one of the most common indications of labor induction, postdate pregnancy can lead to serious maternal and fetal complications. In this study we aimed to compare vaginal misoprostol with intracervical Foley catheter (FC) for cervical ripening in postdate primigravid women. Methods: This randomized clinical trial included 120 primigravid women aged 18-35 years with singleton and postdate pregnancies and Bishop score ≤4. Participants were randomized into two equal groups. The first group received 25 µg vaginal misoprostol and the second group had an 18 Fr FC inserted into their cervical canal. Labor induction was performed using oxytocin in both groups if progression of labor or true contractions did not occur within 6 hours of the interventions. In case of nonreassuring fetal heart rate, fetal distress, placental abruption, or prolonged labor, C-section was performed. Results: The frequency of NVD, C-section, meconium-stained amniotic fluid, and neonatal intensive care unit admission did not differ significantly between groups. Placental abruption and uterine tachysystole occurred more frequently in the misoprostol group (15.0 vs. 1.7%, P=0.008 and 21.7 vs. 0.0%, P<0.001, respectively). A significantly higher number of women in the FC group required oxytocin (73.3 vs. 41.7%, P<0.001). Duration of labor was significantly higher in the FC group (P=0.001). Conclusions: Due to the lower rate of placental abruption and uterine tachysystole observed with FC, it appears to be superior to vaginal misoprostol for cervical ripening in postdate primigravid women; however, its longer labor duration and higher oxytocin requirement should be taken into consideration. Trial registration: Iranian Registry of Clinical Trials, IRCT20181218042033N4. Registered 19/04/2020. Retrospectively registered, https://www.irct.ir/trial/47037

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Vaginal misoprostol versus intracervical Foley catheter for cervical ripening in postdate primigravid women: a randomized clinical trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-021-04011-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nazanin Abdi ◽

Azin Alavi ◽

Forough Pakbaz ◽

Hossein Darabi

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Placental Abruption ◽

Foley Catheter ◽

Labor Induction ◽

Cervical Ripening ◽

Normal Vaginal Delivery ◽

Cervical Canal ◽

Link Type ◽

Vaginal Misoprostol

Abstract Background Being one of the most common indications of labor induction, postdate pregnancy can lead to serious maternal and fetal complications. In this study we aimed to compare vaginal misoprostol with intracervical Foley catheter (FC) for cervical ripening in postdate primigravid women. Methods This randomized clinical trial included 120 primigravid women aged 18–35 years with singleton, postdate pregnancies, and Bishop score ≤ 4. Participants were randomized into two equal groups. The first group received 25 µg vaginal misoprostol and the second group had an 18 Fr FC inserted into their cervical canal. Labor induction was performed using oxytocin in both groups if progression of labor or true contractions did not occur within 6 h of the interventions. In case of nonreassuring fetal heart rate, fetal distress, placental abruption, or prolonged labor, C-section was performed. Results The frequency of normal vaginal delivery, Cesarean section, meconium-stained amniotic fluid, and neonatal intensive care unit admission did not differ significantly between groups. Placental abruption and uterine tachysystole occurred more frequently in the misoprostol group (15.0 vs. 1.7%, P = 0.008 and 21.7 vs. 0.0%, P < 0.001, respectively). A significantly higher number of women in the FC group required oxytocin (73.3 vs. 41.7%, P < 0.001). Duration of labor was significantly higher in the FC group (P = 0.001). Conclusions Due to the lower rate of placental abruption and uterine tachysystole observed with FC, it appears to be superior to vaginal misoprostol for cervical ripening in postdate primigravid women; however, its longer labor duration and higher oxytocin requirement should be taken into consideration. Trial registration Iranian Registry of Clinical Trials, IRCT20181218042033N4. Registered 19/04/2020. Retrospectively registered, https://www.irct.ir/trial/47037

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Titrated oral misoprostol solution versus vaginal misoprostol for labor induction in primi gravid ladies

QJM ◽

10.1093/qjmed/hcaa056.010 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

I M Abdalfattah ◽

W E Mohammed ◽

A A El-gaml

Keyword(s):

Safety Profile ◽

Tap Water ◽

Maternity Hospital ◽

Labor Induction ◽

Induction Of Labor ◽

Cervical Ripening ◽

Controlled Clinical Trial ◽

Solution Versus ◽

Oral Misoprostol ◽

Vaginal Misoprostol

Abstract Background It is now generally accepted that the uterine cervix plays an important role during pregnancy and labor and that it depends on an active ripening process within the cervix; which is necessary for successful labor induction. Aim of the Work to test the safety and efficacy of titrated oral misoprostol compared to vaginal misoprostol for labor induction in term gravid ladies. Patients and Methods This prospective, single-blinded randomized controlled clinical trial was conducted at Ain-Shams University Maternity Hospital during the period between August 2017 and August 2018. 120 pregnant women planned for induction of labor were recruited in the study according to the inclusion / exclusion criteria. Subjects included in the study were randomized into two groups: patients who received oral 200 ug misoprostol in 200 ml water titrated over 24 hours and placebo tablets vaginally which resemble vagiprost tablets (25 microgram misoprostol) and the second group contained pients who received vaginal misoprostol 25microg maximum four doses, and placebo solution of 200 ml of tap water. Results titrated oral misoprostol is as effective in promoting cervical ripening and inducing labor as intravaginal misoprostol, oral Misoprostol has a similar maternal and perinatal safety profile to vaginal misoprostol. Conclusion This new approach to oral misoprostol administration was successful in minimizing the risk of uterine hyper-stimulation, which has been a feature of misoprostol use for induction of labor, at the expense of a somewhat slower response. Oral Misoprostol has a similar maternal and perinatal safety profile compared to vaginal misoprostol.

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