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

NCT05696574 | Unknown

• 1 other identifier: MS-35-2022
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Misoprostol; Labor; Nulliparous; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Onset of active stage of labor

  Duration to onset of active stage of labor

  24 hours postoperatively

Secondary Outcomes (4)

• Cesarean section rate in each group

  Within 24 hours from drug induction

• Doses given

  Intraoperativley

• Augmentation need

  Intraoperatively

• Complications

  48 hours Postoperatively

Study Arms (2)

Vaginal Misoprostol group

EXPERIMENTAL

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

Oral Misoprostol group

EXPERIMENTAL

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

Interventions

Vaginal Misoprostol 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.

Vaginal Misoprostol group

Oral Misoprostol 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.

Oral Misoprostol group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Nulliparous pregnant women who are candidates for induction of labor at or beyond completed 41 weeks
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal age: 18-40.
• 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.
• Single living pregnancy.
• 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).
• Cephalic presentation.
• Bishop score of 6 or less.
• Reactive fetal non-stress test (NST).

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

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

CONTACT

1032205090; mahmoudhamdy2251988@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrics and Gynecology Resident, Cairo University

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 25, 2023
• Study Start: January 20, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study