NCT00306462

Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: Female
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Primary Hypothesis: Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Detailed description

Primary Objective: To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at \<37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation. Secondary Objective: 1. To compare maternal side effects between the two tocolytic agents 2. To compare neonatal morbidities between the two study groups.

Conditions

• Premature Birth
• Premature Labor

Interventions

Type	Name	Description
DRUG	Magnesium sulfate	Intravenous magnesium sulfate 6g bolus, then increased by 1 g/hour till a maximum of 5g/hour; gradually wean down to 2 g/hour for a total of 48 hours once uterine contractions is \< 6/hour.
DRUG	Oral Nifedipine or placebo	Oral nifedipine or placebo at 20 mg every 30 minutes for the first hour, then 20 mg every 3 to 6 hours not to exceed 180 mg in 24 hours, keep maintenance dose at 20 mg every 3 to 6 hours for a total of 48 hours if uterine contractions is \< 6/hour.

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-03-23
• Last updated: 2009-11-09

Locations

1 site across 1 country: United States