Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
- Registration Number
- NCT00545194
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Brief Summary
The aim of this study is to compare two different preparation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 446
Inclusion Criteria
- singleton pregnancy
- cephalic presentation
- gestation of more than 37 Weeks confirmed by ultrasound
- Bishop score less than 7
- Informed consent
Exclusion Criteria
- previous cesarean section (scarred uterus)
- polyhydramnios
- multiple pregnancy
- fetal malformation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Prostaglandin E2 short-acting (instant-released) preparation of prostaglandin E2 A Prostaglandin E2 sustained release preparation of prostaglandin E2
- Primary Outcome Measures
Name Time Method Percentage of vaginal deliveries within the 48 hours after cervical ripening 48 hours
- Secondary Outcome Measures
Name Time Method Apgar score at 5 min less or equal 7 48 hours Number of hypertonia with or without fetal heart rate monitoring abnormalities 48 hours Proportion of total vaginal deliveries 48 hours Vaginal deliveries at 12 hours, 24 hours and 36 hours 48 hours Number of hyperkinesia with or without fetal heart rate monitoring abnormalities 48 hours Apgar score at 10 min less or equal 7 48 hours Arterial pH less or equal 7.20 48 hours Arterial base excess more than 12 48 hours Number of maternal post-partum haemorrhage 48 hours Time to reach 3cm cervical dilatation 48 hours
Trial Locations
- Locations (1)
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
🇫🇷Tours, France