Status:
TERMINATED
Magnesium Sulfate Versus Indomethacin for Preterm Labor
Lead Sponsor:
University of Pennsylvania
Conditions:
Labor, Premature
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the efficacy of Indomethacin compared to Magnesium Sulfate (MgSO4) in reducing neonatal morbidity through a prospective double blind randomized clinical tri...
Eligibility Criteria
Inclusion
- Initial episode of preterm labor for enrollment
- The diagnosis of preterm labor
- Gestational age between 24 and 32 weeks
- Singleton or twin gestation
- The ability to understand the requirements of the study
Exclusion
- Cervical dilation \>5 cms
- Suspected chorioamnionitis
- Fetal distress
- Vaginal bleeding
- Severe pre-eclampsia
- History of gastrointestinal bleeding
- Abnormal renal function
- Suspicion of fetal malformation by ultrasound
- Known allergy to, or intolerance of, Magnesium sulfate and/or Indomethacin
- Documented rupture of amniotic membranes
- Multiple gestations of triplets or more.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00116623
Start Date
February 1 2003
End Date
February 1 2006
Last Update
August 15 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104