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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2017-11-01

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.

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Detailed Description

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Conditions

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Induced Labor Cervical Ripening Obstetric Labor Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Misoprostol

Group of women allocated to misoprostol induction.

Group Type ACTIVE_COMPARATOR

Misoprostol 25 mcg

Intervention Type DRUG

To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.

Dinoprostone

Group of women allocated to dinoprostone induction.

Group Type ACTIVE_COMPARATOR

Dinoprostone 10mg

Intervention Type DRUG

To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Interventions

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Misoprostol 25 mcg

To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.

Intervention Type DRUG

Dinoprostone 10mg

To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.

Intervention Type DRUG

Other Intervention Names

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Misoprostol induction Dinoprostone induction

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes