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 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT04603859
Eligibility Criteria:
Inclusion Criteria:
• Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2
Exclusion Criteria:
* Legal or ethical considerations: maternal age \<18 years, language difficulties requiring an interpreter or translator
* Multiple pregnancy
* Previous caesarean section
* Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement
* Planned elective caesarean section at time of randomisation
* Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery
* Fetal contraindications to expectant management at time of randomisation
* Maternal contraindications to IOL at time of randomisation: e.g. placenta previa/accreta, vasa previa
* Maternal contraindications to expectant management at time of randomisation: e.g. maternal medical conditions, ultrasonically diagnosed oligohydramnios (DVP\< 2 cm), signs of labour including pre-labour rupture of membranes (PROM)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04603859
Study Brief:
Protocol Section:
NCT04603859