Magnesium Sulfate Versus Indomethacin for Preterm Labor

This study has been terminated.

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00116623

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 IV

Drug Information available for: Magnesium Magnesium sulfate Indomethacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment

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

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

Study placed in the following topic categories:

Calcium, Dietary
Pregnancy Complications
Magnesium Sulfate

Obstetric Labor, Premature
Indomethacin
Obstetric Labor Complications

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Calcium Channel Blockers
Central Nervous System Depressants
Anesthetics
Enzyme Inhibitors
Cardiovascular Agents
Reproductive Control Agents
Gout Suppressants
Pharmacologic Actions

Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009