Magnesium Sulfate Versus Indomethacin for Preterm Labor

This study has been terminated.

( Funding completed )

First Received on June 29, 2005. Last Updated on May 7, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Indomethacin Magnesium sulfate Magnesium

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 February 09, 2012