Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2007-07-31

Brief Summary

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To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

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Detailed Description

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Conditions

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Obstetric Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Magnesium Sulfate

Preterm labor treatment with Magnesium Sulfate.

Group Type ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type DRUG

Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Nifedipine

Preterm labor treatment with Nifedipine.

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Interventions

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Magnesium Sulfate

Preterm labor treatment with Magnesium Sulfate 4 gram bolus followed by 2 gm per hour infusion. 2 Gm bolus as needed and/or rate increase up to 4gm per hour were allowed at the discretion of the treating physician.

Intervention Type DRUG

Nifedipine

Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No