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

NCT06874049 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-13

No results posted yet for this study

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

Interventions

DRUG

Vaginal misoprostol

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

DRUG

Oral misoprostol solution (OMS)

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)

Sponsors & Collaborators

  • Hagar Muhammad Abdulfattah Muhammad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06874049 on ClinicalTrials.gov