Cervical Ripening, Induced Labor, Obstetric Labor, Pregnancy
Conditions
Keywords
Dinoprostone, Misoprostol
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.
Interventions
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Sponsors
Hospital Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful vaginal delivery within 24 hours | 24 hours since induction was started | Percentage of women that achieve a vaginal delivery within 24 hours since induction process started |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful cervical ripening within 24 hours | 24 hours since induction was started | Percentage of women that achieve Bishop score \> 6 within 24 hours since induction process started |
| Interval time from induction to delivery | Hours passed between induction of labor until delivery within 72 hours | Time passed since induction of labor started until delivery |
| Need for a second induction | Assessed 24 hours since induction of labor was started | Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor |
| Vaginal delivery rate | Since labor induction had started until delivery had ocurred within 72 hours | Percentage of women that achieve vaginal delivery |
Outcome results
None listed