Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

University of Alexandria

Status: Completed

Conditions: Induced Vaginal Delivery

Treatments: Drug: Vaginal Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT06560515

0107227

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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370 participants in 2 patient groups

Vaginal Dinoprostone

Experimental group

Description:

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

Treatment:

Drug: Vaginal Dinoprostone

Vaginal Misoprostol

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal Dinoprostone