24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction

Study Overview
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Brief Summary
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The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used for induction of labour, and can be administered orally, vaginally, intracervically, endovenously and by extra-amniotic or intra-amniotic routes. Dinoprostone is one of the synthetic prostaglandins most commonly used to achieve cervical ripening and labour induction, and can be administered as tablets, suppositories, gel (vaginal and intracervical) or as a controlled-release intravaginal pessary. The controlled-release pessary has some potential advantages: a single application is required; the insert is easily administered and can be removed as soon as labour starts or if complications ensue. Studies comparing the dinoprostone vaginal insert to other prostaglandin formulations have shown variable results, probably influenced by drug administration regimens, indications for induction, and cervical conditions of the women. The purpose of this study is to assess the efficacy of the induction of labour using dinoprostone in patients with an unfavourable cervix, and to compare the efficacy and the cost of 24-hours controlled-release dinoprostone pessary and intravaginal dinoprostone gel.

Official Title
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A Randomised Controlled Trial of 24-Hours Vaginal Dinoprostone Pessary vs. Gel for Induction of Labour in Term Pregnancies With a Bishop Score ≤4

Conditions
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Labor, Induced, Cervical Ripening

Intervention / Treatment
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* Drug: Dinoprostone vaginal pessary
* Drug: Dinoprostone vaginal gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy, fetal cephalic presentation, Bishop score ≤ 4, gestational age 37-42 weeks Exclusion Criteria: premature rupture of the membranes, history of a previous caesarean section, maternal clinical contraindications to the administration of prostaglandins, fetal malpresentation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>24-hours vaginal dinoprostone pessary | Drug: Dinoprostone vaginal pessary<br>* 10 mg controlled-release dinoprostone pessary applied for 24 hours<br>* Other names: Propess, Ferring, Milan, Italy;|
| Active Comparator: 2<br>Vaginal dinoprostone gel | Drug: Dinoprostone vaginal gel<br>* 2 mg vaginal dinoprostone gel, two daily doses with a 6 hours interval<br>* Other names: Prepidil, Pharmacia, Milan, Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spontaneous vaginal delivery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction to labour time |  |  | 
| induction to delivery time |  |  | 
| rate of failed induction |  |  | 
| cost per patient |  |  | 
| rate of caesarean section for fetal heart rate abnormalities |  |  | 
| 5 minute Apgar score < 7 |  |  | 
| arterial cord blood pH <7.1 |  |  | 
| uterine hyperstimulation |  |  |