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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT03435458
Eligibility Criteria:
Inclusion Criteria:
* female
* pregestational BMI ≥ 30 kg/m2 (weight/height2)
* singleton pregnancy with cephalic presentation
* nulliparous
* ≥ 36 weeks gestational age
* decision of induction of labor
* bishop score ≤ 5
* ≤ 3 uterine contractions / 10 min
* ≥ 18 years of age
* personally signed and dated informed consent document
* ability to comply with the requirement of the study
* insurance coverage
Exclusion Criteria:
* deceleration on Fetal Heart Rate (FHR)
* placenta praevia
* bleeding
* premature rupture of membrane
* chorioamnionitis
* allergy to prostaglandins
* contraindication to ballon
* active genital herpes infection
* HIV infection
* fetal serious congenital anomaly
* patient subject to a legal protection order
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03435458
Study Brief:
Protocol Section:
NCT03435458