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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT05857059
Eligibility Criteria:
Inclusion Criteria:
* BMI ≥ 30 kg/m2 recorded based on maternal weight at preconception or in the first trimester
* Singleton live gestation with vertex presentation
* Pregnancies followed in our institution with sonographic confirmation of gestational age in the first trimester
* Obstetrical indication for labor induction
* Bishop score of \<5 at the time of induction of labor
Exclusion Criteria:
* Underweight and normal weight women (BMI \<30 kg/m2)
* Known hypersensitivity to prostaglandins
* Preterm gestations (\< 37 weeks)
* Multiple gestation
* Women who cannot give their informed consent
* Contraindications for vaginal delivery
* Previous c-section or uterine scar due to previous gynecological surgery
* Maternal or fetal pathology (for example: fetal indications: non-reassuring fetal status - intra-uterine growth restriction with abnormal umbilical doppler, abnormal fetal cardiac rhythm; stillbirth; or maternal/pregnancy related indications such as placenta previa)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
55 Years
Study:
NCT05857059
Study Brief:
Protocol Section:
NCT05857059