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

NCT06874049 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 1525
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Ripening and Induction of Labor

Outcome Measures

Primary Outcomes (1)

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

  24 hours max

Study Arms (2)

vaginal misoprostol solution

EXPERIMENTAL

the vaginal 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.

Drug: Vaginal misoprostol

oral misoprostol solution

ACTIVE COMPARATOR

the first group 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).

Drug: Oral misoprostol solution (OMS)

Interventions

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

vaginal misoprostol solution

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)

oral misoprostol solution

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hagar Muhammad Abdulfattah Muhammad: lead

Study Sites (1)

Ain Shams university Maternity Hospital

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Obstetrics and Gynecology resident

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 13, 2025
• Study Start: February 26, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

EG (1)