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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT07265518
Eligibility Criteria:
Inclusion Criteria:
* Pregnant woman with singleton pregnancy in cephalic presentation
* Term ≥ 37SA+0d
* Age ≥ 18 years
* Affiliated or beneficiary of a social security scheme
* No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
* Indication for balloon induction
* Bishop score \<6
* Home-hospital distance ≤ 30 minutes' drive
* Presence of a family member at the woman's side to help her return home
Exclusion Criteria:
* Scarred uterus
* Fetal heart rhythm abnormalities
* Rupture of membranes
* Death in utero
* Placenta previa or adherent placenta (accreta or percreta)
* Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology
* Anamnios
* Patient under guardianship, curatorship and/or safeguard of justice
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07265518
Study Brief:
Protocol Section:
NCT07265518