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:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT07301957
Eligibility Criteria:
Inclusion Criteria:
* Women over 18 years of age
* Single foetal pregnancy, cephalic presentation
* diagnosis of membrane rupture with persistence of one membrane and absence of immediate spontaneous labour.
* Person affiliated with or beneficiary of a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
Exclusion Criteria:
* Minor patient
* patient under guardianship/curatorship,
* multiple pregnancy, pregnancy with foetal death
* non-cephalic presentation
* gestational age less than 37 weeks,
* rupture of membranes more than 12 hours ago
* contraindication to vaginal deliver
* meconium-stained amniotic fluid,
* clinical signs suggestive of intrauterine infection (maternal hyperthermia \>38°C, maternal and/or foetal tachycardia, purulent amniotic fluid),
* cervix not accessible for artificial rupture
* vaginismus
* contraindication to a potential expectant management
* indication for induction for another reason
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07301957
Study Brief:
Protocol Section:
NCT07301957