Status:
WITHDRAWN
Vaginal Progesterone as a Treatment for Women Active Preterm Labor
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Juniper Pharmaceuticals, Inc.
Conditions:
Labor, Premature
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare how well vaginal progesterone works delaying the time to delivery in women with preterm labor compared to placebo. The study will also compare the effect of vag...
Detailed Description
Preterm birth remains a leading cause of perinatal mortality and morbidity. Despite advances in obstetric and pediatric care, the incidence of preterm birth has increased by more than 20% in the last ...
Eligibility Criteria
Inclusion
- Age 18 or older
- Singleton gestation
- Gestational age between 24 0/7 and 33 6/7 weeks of pregnancy by best obstetric estimate
- Preterm labor, defined as more than 6 uterine contractions in 30 minutes associated with cervical change, either shortening and/or dilation by manual exam.
- Management with standard of care tocolytic therapy (nifedipine)
- Planned delivery at Strong Memorial Hospital or Highland Hospital
Exclusion
- Cervical dilation more than 4 cm.
- Evidence of rupture of membranes
- Negative fetal fibronectin (if done prior to admission)
- Cervical length greater than 3 cm
- Presence of cervical cerclage
- Major fetal anomaly
- Small for gestational age, i.e., fetuses with estimated fetal weight below the 10th percentile by ultrasound
- Evidence of chorioamnionitis (Temperature \>100.4oF with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
- Suspected placental abruption or significant hemorrhage
- Category III fetal heart rate pattern
- Presence of co-existing medical conditions, including maternal diabetes and hypertension and seizure disorder
- Use of any progesterone in current pregnancy within 4 weeks of enrollment
- First dose of standard tocolytic therapy more than 6 hours prior to randomization
- Allergies to progesterone and progesterone gel
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01206998
Start Date
July 1 2010
End Date
August 1 2010
Last Update
October 1 2012
Active Locations (1)
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1
Strong Memorial Hospital
Rochester, New York, United States, 14642