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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07366359
Eligibility Criteria:
Inclusion Criteria
* Maternal age ≥ 18 years
* Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound
* Live singleton fetus
* Prelabor rupture of membranes (PROM) confirmed by at least one of the following:
* Amniotic fluid visibly draining from the cervical os during sterile speculum examination
* Pool of fluid in the posterior fornix
* Cephalic presentation
* Bishop score ≤ 6
* No spontaneous uterine contractions
* No contraindications for vaginal delivery
Exclusion Criteria:
* Active labor
* Previous uterine surgery (e.g., cesarean section)
* Chorioamnionitis or non-reassuring fetal status
* Major fetal anomalies
* Contraindications to prostaglandin or vaginal delivery
* Refusal to participate
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07366359
Study Brief:
Protocol Section:
NCT07366359