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

Study Overview
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Brief Summary
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To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

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

Conditions
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Obstetric Labor, Premature

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Drug: Nifedipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium Sulfate<br>Preterm labor treatment with Magnesium Sulfate. | Drug: Magnesium Sulfate<br>* 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.<br>|
| Active Comparator: Nifedipine<br>Preterm labor treatment with Nifedipine. | Drug: Nifedipine<br>* Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence | Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation. | 48 hours after administration of study medication. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Uterine Quiescence | Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change. | Until delivery, up to 42 weeks of gestation | 
| Gestational Age at Delivery | Presented as weeks | Until delivery, up to 42 weeks of gestation | 
| Neonatal Birth Weight | Presented as grams | Until delivery, up to 42 weeks of gestation | 
| Serious Maternal Adverse Effect | A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension. | From study enrollment until discharge from delivery hospital, up to 30 days after delivery. | 
| Composite Neonatal Morbidity | Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death. | From delivery until discharge from the hospital, up to 30 days of age |