Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Induced Vaginal Delivery
• Intervention / Treatment: Drug: Vaginal Dinoprostone

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • ElShatby University Maternal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Dinoprostone; received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart.	Drug: Vaginal Dinoprostone; induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol
Active Comparator: Vaginal Misoprostol; received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart.	Drug: Vaginal Dinoprostone; induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum hemorrhage	quantification of amount of postpartum bleeding	after delivery of the placenta
neonatal outcomes	Apgar Score at 1 and 5 minutes	at 1 and 5 minutes of delivery

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: 0107227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No