Induction of Labor in Term Pregnancies With Unfavourable Cervix

Phase 4

Completed

• Conditions: Prostaglandins Causing Adverse Effects in Therapeutic Use; Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly; Drug: Dinoprostone 0.5 MG

• Registration Number: NCT04280874
• Lead Sponsor: Clinical Hospital Merkur

Brief Summary

This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.

Detailed Description

This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

Inclusion Criteria

• term pregnancies (> 37 weeks gestation)
• unfavourable cervix (Bishop score <6)
• indication for labor induction
• absence of uterine contractions
• reassuring cardiotocography

Exclusion Criteria

• ruptured membranes
• scar uterus (previous caesarean section or uterus surgery)
• pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP B	Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly	106 randomly selected pregnant women
GROUP A	Dinoprostone 0.5 MG	106 randomly selected pregnant women

Primary Outcome Measures

Name	Time	Method
time period between beginning of labor induction to delivery	5 days	hours (difference of 4 hours or more is considered significant)

Secondary Outcome Measures

Name	Time	Method
number of deliveries by caesarean section or instrumental deliveries	7 days	N (%)
number of births within 24h of start of labor induction	7 days	N (%)
number of uterus hyperstimulation	7 days	N (%)

Trial Locations

Locations (1)

Clinical Hospital Merkur; 🇭🇷 Zagreb, Croatia