Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor

The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor.

The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.

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Key information

Conditions

Cervical Ripening and Induction of Labor

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain Shams university Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with a singleton pregnancy.
Cephalic presentation.
Age range: 18-40 years.
Gestational age between 36 and 42 weeks.
Intact fetal membranes.
Absence of spontaneous uterine contractions.
Non favorable cervix (Bishop score ≤ 5).
A reactive non stress test in case of positive fetal life.

Exclusion criteria

History of cesarean section or uterine scars
Grand Multipara P ≥5
Known fetal non-cephalic presentation
Any known allergy to misoprostol.
Multiple pregnancy
Contraindication to vaginal delivery.

Treatment and study plan

Vaginal Misoprostol

Drug

the vaginal misoprostol solution will be prepared by complete crushing of one misoprostol 200 µg tablet into powder then adding the powder into a clean urine specimen cup then adding 20 cc of KY gel measured by a 20 ml syringe then mix the contents together to ensure adequate distribution of the powder , each patient will receive only 2.5cc of the mixture vaginally (inserted into the posterior fornix,) by using medical 3ml syringes equal to 25 mcg misoprostol 4 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023) and remain recumbent for 10-20 minutes

Oral misoprostol solution (OMS)

Drug

the solution will be prepared by dissolving one 200 µg tablet in 200 ml of tap water , each member will receive 25 cc misoprostol solution equal to 25 mcg misoprostol 2 hourly according to International Federation of Gynecology and Obstetrics (FIGO2023)

Primary outcomes

The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval.

Time frame: 24 hours max

Sponsors and collaborators

Lead sponsor

Hagar Muhammad Abdulfattah Muhammad

Other

Registry information

Official study title

Oral Versus Vaginal Misoprostol Solution Among Pregnant Women Undergoing Induction of Labor At Ain Shams University Maternity Hospital a Randomized Controlled Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 13, 2025
Registry last updated: Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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