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

NCT ID: NCT05696574

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-06-20

Brief Summary

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.

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.

Conditions

Misoprostol; Labor; Nulliparous; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaginal Misoprostol

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Oral Misoprostol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Elsayed Fekry Elsayed Omran

Obstetrics and Gynecology Resident, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Elsayed F. Omran, M.B.B.CH

Role: CONTACT

mahmoudhamdy2251988@gmail.com

1032205090 ext. +20

Other Identifiers

MS-35-2022

Identifier Type: -

Identifier Source: org_study_id