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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
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.
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.
University Hospital
Cincinnati, Ohio, United States
Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation
Time frame: 4 years
Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity
Time frame: 4 years and 9 months
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