Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

NCT06560515 | Completed

• 1 other identifier: 0107227
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induced Vaginal Delivery

Outcome Measures

Primary Outcomes (2)

• Sucess of induction

  percentage of women with a successful vaginal delivery

  number of women who delivered vaginally after induction

• Induction to delivery time

  time lapse from receiving first dose of induction till delivery of the fetus

  time from start of induction till delivery of the fetus

Secondary Outcomes (2)

• Postpartum hemorrhage

  after delivery of the placenta

• neonatal outcomes

  at 1 and 5 minutes of delivery

Study Arms (2)

Vaginal Dinoprostone

EXPERIMENTAL

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

Drug: Vaginal Dinoprostone

Vaginal Misoprostol

ACTIVE COMPARATOR

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

Drug: Vaginal Dinoprostone

Interventions

Vaginal Dinoprostone DRUG

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

Vaginal Dinoprostone; Vaginal Misoprostol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any signs of labour (Prelabor rupture of membranes)
• Grand Multiparous women (parity of 4 or more)
• IUFD
• fetal weight \> 4 kg
• BMI \> 35

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

ElShatby University Maternal Hospital

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)