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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04230967
Eligibility Criteria:
Inclusion Criteria
* Pregnant women aged 12-55
* Gestational age 23 0/7 to 35 0/7 weeks
* PPROM confirmed by clinical diagnosis which includes sterile speculum examination with pooling, ferning, and nitrazine tests, or the Amnisure ROM Test
* Planned inpatient expectant management with delivery goal \>=7 days from enrollment
* Ability to provide informed consent in English or Spanish
Exclusion Criteria
* Imminent delivery
* Transverse or footling breech presentation (if multiple gestation, presenting fetus)
* Unstable lie (if multiple gestation, presenting fetus)
* Funic presentation (if multiple gestation, presenting fetus)
* Active vaginal bleeding
* Regular, painful contractions (\>=3 in 10 minutes for 30 minutes or more) consistent with labor
* Clinical contraindication to ambulation as determined by the managing physician
* Physician declines to have the patient approached for participation
* Lethal fetal anomalies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
55 Years
Study:
NCT04230967
Study Brief:
Protocol Section:
NCT04230967