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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT01402050
Eligibility Criteria:
Inclusion Criteria:
1. Cervix \< 3 cm dilated. If 2cm dilated, must be \< 80% effaced.
2. Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
3. Singleton gestation
4. Cephalic presentation
Exclusion Criteria:
1. Regular uterine contractions (more frequent than every 5 minutes)
2. PROM
3. Prior transverse uterine incision or any obstetric contraindication to labor
4. Fever (defined as a temperature of 38°C or higher)
5. Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
6. Fetal death
7. Placenta previa
8. Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
9. Non-reassuring fetal heart rate pattern
10. HIV
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01402050
Study Brief:
Protocol Section:
NCT01402050