Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04949633
Eligibility Criteria:
Inclusion Criteria:
* Pregnant woman
* ≥ 18 years old
* With a singleton cephalic pregnancy
* ≥37+0 weeks of gestation
* Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation)
* With a medical indication of labor with a previous pharmacological or mechanical cervical ripening of 24 hours
* Bishop score ≤ 6 at inclusion (unfavorable cervix)
* French health insurance policy holder
* Written informed consent
Exclusion Criteria:
* Any measures of legal protection
* Prior caesarean section or uterine scar
* Contra-indications to a vaginal delivery
* Foetus with suspected severe congenital abnormalities
* Pathological foetal heart rate
* Contra-indications to ANGUSTA® (oral misoprostol, cervical ripening agent)
* Contra-indications to PROPESS® (vaginal slow releasing system of dinoprostone, cervical ripening agent)
* Contra-indications to PROSTINE® (vaginal gel of dinoprostone, cervical ripening agent)
* Contra-indications for using oxytocin
* Woman in labor
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04949633
Study Brief:
Protocol Section:
NCT04949633