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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT02132533
Eligibility Criteria:
Inclusion Criteria:
* Between 16 and 44 years of age inclusive
* Singleton pregnancy
* Intact membranes
* Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
* Reported or documented uterine activity
* Cervical dilation between 2 cm and 4 cm inclusive
Exclusion Criteria:
* Multifetal gestation
* Less than 28 weeks' gestation
* 34 or more weeks' gestation
* Ruptured membranes
* More than 4 cm dilated
* Previously received a course of corticosteroids for fetal lung maturation
* Oligohydramnios
* Fetal growth restriction
* Chorioamnionitis or temperature of at least 38.0 degrees Celsius
* Fetal death
* Preeclampsia
* Suspected placental abruption or placenta previa
* Lethal fetal malformation or amniotic fluid index at least 35
* Systolic BP \< 90 mmHg or diastolic BP \< 50 mmHg
* Baseline tachycardia (pulse \>120 after 2 consecutive measurements 30 minutes apart)
* Chronic hypertension treated with antihypertensives in pregnancy
* Seizure disorder or HIV
* Maternal allergy to nifedipine
* Known maternal cardiac disease
* Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
44 Years
Study:
NCT02132533
Study Brief:
Protocol Section:
NCT02132533