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Magnesium Sulfate Versus Indomethacin for Preterm Labor

This study has been terminated.
(Funding completed)
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00116623
First received: June 29, 2005
Last updated: May 7, 2007
Last verified: May 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116623

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: George A Macones, M.D. University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116623     History of Changes
Other Study ID Numbers: 704914
Study First Received: June 29, 2005
Last Updated: May 7, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Magnesium Sulfate
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 19, 2013