Magnesium Sulfate Versus Indomethacin for Preterm Labor
Information source: University of Pennsylvania
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Labor, Premature
Intervention: Indomethacin (Drug); Magnesium sulfate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s):
George A Macones, M.D., Principal Investigator, Affiliation: University of Pennsylvania
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 trial. The specific aim of the project is to test the hypothesis that
Indomethacin, compared to MgSO4, will decrease the proportion of neonates diagnosed with
major complications or death.
Clinical Details
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information
Last updated: May 7, 2007
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