Magnesium Sulfate Versus Indomethacin for Preterm Labor

Stopped early · Phase 4

Conditions studied: Labor, Premature

In brief

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.

Key facts

Study ID

NCT00116623

Run by

University of Pennsylvania

Starts

2003-02-01

Expected to finish

2006-02-01

Last updated by the study team

2016-08-15

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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