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Magnesium Sulfate Versus Indomethacin for Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116623
Recruitment Status : Terminated (Funding completed)
First Posted : June 30, 2005
Last Update Posted : August 15, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Labor, Premature Drug: Indomethacin Drug: Magnesium sulfate Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : February 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116623

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: George A Macones, M.D. University of Pennsylvania
Layout table for additonal information Identifier: NCT00116623    
Other Study ID Numbers: 704914
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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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
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors