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Magnesium Sulfate Versus Indomethacin for Preterm Labor

This study has been terminated.
(Funding completed)
Information provided by:
University of Pennsylvania Identifier:
First received: June 29, 2005
Last updated: August 12, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Labor, Premature
Drug: Indomethacin
Drug: Magnesium sulfate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Study Start Date: February 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00116623

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: George A Macones, M.D. University of Pennsylvania
  More Information Identifier: NCT00116623     History of Changes
Other Study ID Numbers: 704914 
Study First Received: June 29, 2005
Last Updated: August 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Magnesium Sulfate
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016