Magnesium Sulfate Versus Indomethacin for Preterm Labor

Phase 4

Terminated

• Conditions: Labor, Premature

• Registration Number: NCT00116623
• Lead Sponsor: University of Pennsylvania

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-06-29
• Study First Submitted QC: 2005-06-29
• Study First Posted: 2005-06-30
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States