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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT01840228
Eligibility Criteria:
Inclusion Criteria:
* Singleton or twin gestation
* Estimated gestational age between 24 0/7 and 33 6/7 weeks' gestation
* Initially present with regular contractions and clinical diagnosis of preterm labor but remain undelivered with 1) no further cervical change 12 hours after discontinuation of acute tocolytic therapy; or 2) be considered eligible for discharge based on attending physician judgment prior to the 12 hour period of time
* The participant's cervix must be at least 1 cm at the time of enrollment
Exclusion Criteria:
* Non-English speaking
* Rupture of membranes
* Chorioamnionitis
* Non-reassuring fetal status
* Maternal indication for delivery
* Placental abruption
* Intrauterine fetal demise
* Prenatally diagnosed major fetal anomaly
* Cervical cerclage in place
* Previous administration of progesterone during the current pregnancy for a history of preterm birth or short cervix
* Participant is either unwilling or unable to attend follow-up study visits following hospital discharge
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01840228
Study Brief:
Protocol Section:
NCT01840228