Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


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.


NCT ID:

NCT00116623


Primary Contact:

Principal Investigator
George A Macones, M.D.
University of Pennsylvania


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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