Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women

Comparative Study Between Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women at or Beyond Completed 41 Weeks

The aim of this study is to compare the efficacy and the safety of vaginal misoprostol with oral misoprostol for induction of labor in nulliparous pregnant women at or beyond completed 41 weeks.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Labor; Misoprostol; Nulliparous
• Intervention / Treatment: Drug: Vaginal Misoprostol; Drug: Oral Misoprostol

Detailed Description

Induction of labor is carried out for maternal and fetal indications and one of the most common indications is prolonged pregnancy.

Recent studies have suggested that by continuing pregnancy beyond 41 weeks, there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother. Thus, there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management.

Misoprostol, a prostaglandin E1 analog, is indicated for protection against gastric ulcers, but when administered prenatally it causes uterine contractions. Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction, resulting in shorter induction-to-delivery intervals, without any increase in adverse outcomes. It has the advantage of being cheap, stable at room temperature, and easy to be administered by various routes i.e., vaginal, oral, sublingual, or rectal.

The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol. Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite, misoprostol, peaking at 15 minutes with a half-life of 20-40 minutes. Misoprostol then undergoes early rapid elimination over 120 minutes, followed by slow elimination thereafter. The medication rapidly makes its way to the myometrium. ln contrast, after vaginal misoprostol administration, plasma concentration gradually increase, reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elsayed F. Omran, M.B.B.CH; Phone Number: +20 1032205090; Email: mahmoudhamdy2251988@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Maternal age: 18-40.
2. Nullipara: a woman who has never completed a pregnancy beyond 20 weeks gestation. She may not have been pregnant or may have had a spontaneous or elective abortion(s) or an ectopic pregnancy.
3. Single living pregnancy.
4. Gestational age: at or beyond completed 41 weeks (confirmed by a reliable date for the last menstrual period, regular cycle, or/and 1st trimesteric ultrasound scan).
5. Cephalic presentation.
6. Bishop score of 6 or less.
7. Reactive fetal non-stress test (NST).

Exclusion Criteria:

1. Any maternal chronic diseases or pregnancy-induced medical disorders.
2. Fetal anomalies.
3. Fetal macrosomia (>4 Kg).
4. Intrauterine Growth Restriction (IUGR) (EFW below the 10th percentile for gestational age).
5. Rupture of membranes or oligohydramnios (AFI < the fifth percentile).
6. Previous uterine scar.
7. Regular uterine contractions.
8. Any contraindication to vaginal delivery e.g., placenta previa (complete or partial covering of the internal os of the cervix with the placenta).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Misoprostol group; Women in this group will include 40 pregnant women who will be offered misoprostol (placed in the post-fornix of the vagina) in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.	Drug: Vaginal Misoprostol; Women in this group will include 40 pregnant women who will be offered misoprostol (placed in the post-fornix of the vagina) in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.
Experimental: Oral Misoprostol group; Women in this group will include 40 pregnant women who will be offered oral misoprostol in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.	Drug: Oral Misoprostol; Women in this group will include 40 pregnant women who will be offered oral misoprostol in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of active stage of labor	Duration to onset of active stage of labor	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean section rate in each group	Cesarean section rate will be recorded	Within 24 hours from drug induction
Doses given	Number of durg doses given will be recored	Intraoperativley
Augmentation need	Number of participants need for labor augmentation with oxytocin and/or amniotomy will be evaluated	Intraoperatively
Complications	Any complications will be recorded	48 hours Postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2023
• Primary Completion (Anticipated): June 20, 2023
• Study Completion (Anticipated): June 20, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: MS-35-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be available under a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No