Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-10-31

Brief Summary

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This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility \& enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

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Detailed Description

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Conditions

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Induced Vaginal Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vaginal Dinoprostone

received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart.

Group Type EXPERIMENTAL

Vaginal Dinoprostone

Intervention Type DRUG

induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

Vaginal Misoprostol

received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

Group Type ACTIVE_COMPARATOR

Vaginal Dinoprostone

Intervention Type DRUG

induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

Interventions

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Vaginal Dinoprostone

induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* pregnant women at 40 weeks or beyond
* singleton pregnancy
* Bishop score 4 or more
* fetus in a cephalic presentation
* Adequate fetal biophysical profile