Magnesium Sulfate Versus Indomethacin for Preterm Labor

Phase 4TerminatedNCT00116623

University of Pennsylvania

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Labor, Premature

Interventions

IndomethacinDRUG

Magnesium sulfateDRUG

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Data from ClinicalTrials.gov

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