Cervical Ripening, Labor, Induced
Conditions
Keywords
Prostaglandin E2, Intravaginal gel, Bishop score, Induction of labor, randomized trial, Vaginal insert
Brief summary
The aim of this study is to compare two different preparation
Interventions
DRUGProstaglandin E2
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of vaginal deliveries within the 48 hours after cervical ripening | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of hypertonia with or without fetal heart rate monitoring abnormalities | 48 hours |
| Apgar score at 5 min less or equal 7 | 48 hours |
| Proportion of total vaginal deliveries | 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 |
| Apgar score at 10 min less or equal 7 | 48 hours |
Countries
France
Outcome results
None listed