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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT03985618
Eligibility Criteria:
Inclusion Criteria:
* Capability of participant to comprehend and comply with study requirements
* Age ≥18 years at time of consent
* Nulliparous (never given birth after 19+6/7 weeks of gestation)
* Pre-pregnancy BMI or calculated BMI obtained in the first 13 weeks of pregnancy ≥40kg/ m2
* Participant plans to give birth in a participating site
* Gestational age 34+0/7 - 36+6/7 weeks (based on estimated date of conception (EDC) assigned at the first ultrasound performed after 7+0/7 and prior to 20 +0/7 weeks)
* Live fetus, documented positive heart rate at visit 1 prior to randomization
* Singleton fetus in cephalic presentation at the time of randomization
* No maternal or fetal contraindications to vaginal delivery
Exclusion Criteria:
* Known major fetal anomaly, confirmed by ultrasound or genetic testing
* Multiple gestation
* Known documented evidence of alcohol or drug abuse in this current pregnancy
* Currently enrolled or has participated in another clinical trial within 3 months of the date of randomization (at discretion of Trial Coordinating Centre)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03985618
Study Brief:
Protocol Section:
NCT03985618