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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT01954095
Eligibility Criteria:
Inclusion Criteria
All Groups
* Singleton gestation (16 0/7 - 23 6/7 weeks gestation)
* Willing to provide informed consent
* Age 18 - 50 years inclusive
Additionally,
Group 1: One or more prior term births (\>37 0/7 weeks); No prior spontaneous birth at 16 0/7 - 36 6/7 weeks; and normal cervical length (\>25 mm)
Group 2: Cervical length of 20 mm or less at 16 0/7 - 23 6/7 weeks
Groups 3 and 4: History of prior spontaneous birth at 16 0/7 - 34 0/7 weeks and normal cervical length (\> 25mm) at enrollment.
Exclusion Criteria
All Groups
* Active labor
* Active bleeding
* On progestin therapy, chronic steroid, or current NSAID therapy
* Actively receiving study treatment in another clinical trial (observational trials allowed)
* Major fetal malformation lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e.g., gastroschisis, spina bifida, or serious karyotypic abnormalities
* Amniotic membranes prolapsed beyond the external os (ostium of uterus) or protruding into the vagina
* Pregnancy without a viable fetus
* Prenatal care or delivery planned elsewhere (unless the study visits can be made as scheduled and complete outcome information can be obtained)
Additionally:
Group 1: Cervical dilation greater than or equal to 3cm
Group 2: Prior preterm birth (16 0/7 - 34 0/7); active deep vein thrombosis, pulmonary embolism, or history of these conditions; known liver dysfunction or disease (active hepatitis, HIV)
Group 3: inability or unwillingness to use a 17-OHPC compounded product similar in composition to the FDA-approved product; allergy to 17-OHPC or its components
Groups 1, 3, and 4: cerclage in place or anticipated; congenital mullerian abnormality of the uterus; positive for bacterial vaginosis, chlamydia, gonorrhea, or trichomonas
Groups 3 and 4: current or history of thrombosis or thromboembolic disorders; known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions; undiagnosed abnormal vaginal bleeding unrelated to pregnancy; cholestatic jaundice of pregnancy, liver tumors, benign or malignant, or active liver disease; uncontrolled hypertension
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01954095
Study Brief:
Protocol Section:
NCT01954095