Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 198
- Primary Endpoint
- Successful vaginal delivery within 24 hours
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Misoprostol
Group of women allocated to misoprostol induction.
Intervention: Misoprostol 25 mcg (Drug)
Dinoprostone
Group of women allocated to dinoprostone induction.
Intervention: Dinoprostone 10mg (Drug)
Outcomes
Primary Outcomes
Successful vaginal delivery within 24 hours
Time Frame: 24 hours since induction was started
Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
Secondary Outcomes
- Need for a second induction(Assessed 24 hours since induction of labor was started)
- Vaginal delivery rate(Since labor induction had started until delivery had ocurred within 72 hours)
- Successful cervical ripening within 24 hours(24 hours since induction was started)
- Interval time from induction to delivery(Hours passed between induction of labor until delivery within 72 hours)
Investigators
Jose Manuel Campillos Maza
Head of Unit of Maternal-Fetal Medicine
Hospital Miguel Servet