Induction of Labor in Term Pregnancies With Unfavourable Cervix

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix

Conditions
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Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
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* Drug: Dinoprostone 0.5 MG
* Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP A<br>106 randomly selected pregnant women | Drug: Dinoprostone 0.5 MG<br>* 0.5mg dinoprostone applied intracervically<br>* Other names: PREPIDIL;|
| Active Comparator: GROUP B<br>106 randomly selected pregnant women | Drug: Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly<br>* 2mg dinoprostone applied intravaginally<br>* Other names: PROSTIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time period between beginning of labor induction to delivery | hours (difference of 4 hours or more is considered significant) | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of births within 24h of start of labor induction | N (%) | 7 days | 
| number of deliveries by caesarean section or instrumental deliveries | N (%) | 7 days | 
| number of uterus hyperstimulation | N (%) | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dinoprostone, Bishop score, labor induction, term pregnancy