Magnesium Sulfate Versus Indomethacin for Preterm Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Indomethacin

Intervention Type DRUG

Magnesium sulfate

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes