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

Hospital Miguel Servet198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

198

Conditions

Induced Labor Cervical Ripening Obstetric Labor Pregnancy

Misoprostol 25 mcgDRUG

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

Dinoprostone 10mgDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Successful vaginal delivery within 24 hours

Percentage of women that achieve a vaginal delivery within 24 hours since induction process started

Time frame: 24 hours since induction was started

Secondary Outcomes

Successful cervical ripening within 24 hours

Percentage of women that achieve Bishop score \> 6 within 24 hours since induction process started

Time frame: 24 hours since induction was started

Interval time from induction to delivery

Time passed since induction of labor started until delivery

Time frame: 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

Time frame: Assessed 24 hours since induction of labor was started

Vaginal delivery rate

Percentage of women that achieve vaginal delivery

Time frame: Since labor induction had started until delivery had ocurred within 72 hours