Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

Not Applicable

Completed

• Conditions: Induced Vaginal Delivery
• Interventions: Drug: Vaginal Dinoprostone

• Registration Number: NCT06560515
• Lead Sponsor: University of Alexandria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Dinoprostone	Vaginal Dinoprostone	received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart.
Vaginal Misoprostol	Vaginal Dinoprostone	received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

Primary Outcome Measures

Name	Time	Method
Sucess of induction	number of women who delivered vaginally after induction	percentage of women with a successful vaginal delivery
Induction to delivery time	time from start of induction till delivery of the fetus	time lapse from receiving first dose of induction till delivery of the fetus

Secondary Outcome Measures

Name	Time	Method
Postpartum hemorrhage	after delivery of the placenta	quantification of amount of postpartum bleeding
neonatal outcomes	at 1 and 5 minutes of delivery	Apgar Score at 1 and 5 minutes

Trial Locations

Locations (1)

ElShatby University Maternal Hospital; 🇪🇬 Alexandria, Egypt