Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor
Oral Versus Vaginal Misoprostol Solution Among Pregnant Women Undergoing Induction of Labor At Ain Shams University Maternity Hospital a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt
- Ain Shams University Maternity Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: vaginal misoprostol solution
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.
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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
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Active Comparator: oral misoprostol solution
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).
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval.
Time Frame: 24 hours max
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24 hours max
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1525
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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