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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00116623 |
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 |
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Labor, Premature |
Drug: Indomethacin Drug: Magnesium sulfate |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | George A Macones, M.D. | University of Pennsylvania |
Study ID Numbers: | 704914 |
Study First Received: | June 29, 2005 |
Last Updated: | May 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00116623 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Pregnancy Complications Obstetric Labor, Premature Magnesium Sulfate Cyclooxygenase Inhibitors Obstetric Labor Complications Calcium Channel Blockers Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Calcium, Dietary Analgesics, Non-Narcotic Indomethacin Anti-Inflammatory Agents, Non-Steroidal Anti-Arrhythmia Agents Analgesics Peripheral Nervous System Agents Antirheumatic Agents Anticonvulsants |
Anti-Inflammatory Agents Pregnancy Complications Molecular Mechanisms of Pharmacological Action Magnesium Sulfate Obstetric Labor, Premature Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Reproductive Control Agents Gout Suppressants Membrane Transport Modulators Tocolytic Agents Sensory System Agents Therapeutic Uses Indomethacin |
Anti-Inflammatory Agents, Non-Steroidal Anti-Arrhythmia Agents Analgesics Cyclooxygenase Inhibitors Obstetric Labor Complications Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Anticonvulsants |