Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor

Study Overview
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Brief Summary
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Purpose: To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies. Methods: The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.

Official Title
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Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial

Conditions
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Induced Labor, Cervical Ripening, Obstetric Labor, Pregnancy

Intervention / Treatment
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* Drug: Misoprostol 25 mcg
* Drug: Dinoprostone 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton uncomplicated pregnancy Nulliparity Live fetus 286 days of gestational age or above Abscence of contraindication for vaginal delivery Bishop score lower than 6 Exclusion Criteria: Multiple pregnancy Multiparity Stillbirth Oligohydramnios Suspected fetal distress Severe asthma Intolerance/allergy to prostaglandins Contraindication for vaginal birth

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol<br>Group of women allocated to misoprostol induction. | Drug: Misoprostol 25 mcg<br>* To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.<br>* Other names: Misoprostol induction;|
| Active Comparator: Dinoprostone<br>Group of women allocated to dinoprostone induction. | Drug: Dinoprostone 10mg<br>* To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.<br>* Other names: Dinoprostone induction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful vaginal delivery within 24 hours | Percentage of women that achieve a vaginal delivery within 24 hours since induction process started | 24 hours since induction was started | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cervical ripening within 24 hours | Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started | 24 hours since induction was started | 
| Interval time from induction to delivery | Time passed since induction of labor started until delivery | Hours passed between induction of labor until delivery within 72 hours | 
| Need for a second induction | Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor | Assessed 24 hours since induction of labor was started | 
| Vaginal delivery rate | Percentage of women that achieve vaginal delivery | Since labor induction had started until delivery had ocurred within 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dinoprostone, Misoprostol