Status:
TERMINATED
Vaginal Progesterone for the Prevention of Preterm Birth in Women With Arrested Preterm Labor
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Premature Birth
Obstetric Labor, Premature
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
Preterm birth, defined as birth before 37 weeks' gestation, is a leading cause of infant death and disease. Progesterone is the single most effective intervention in the prevention of preterm birth. H...
Detailed Description
RESEARCH DESIGN AND METHODS The investigators will perform a randomized, blinded, placebo-controlled trial to evaluate the use of vaginal progesterone in women with arrested preterm labor after 24 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2018
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01840228
Start Date
May 1 2013
End Date
May 7 2018
Last Update
June 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine/ Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110