To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
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.
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
Stanford University School of Medicine
Stanford, California, United States
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.
Time frame: 48 hours after administration of study medication.
Time to Uterine Quiescence
Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
Time frame: Until delivery, up to 42 weeks of gestation
Gestational Age at Delivery
Presented as weeks
Time frame: Until delivery, up to 42 weeks of gestation
Neonatal Birth Weight
Presented as grams
Time frame: 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.
Time frame: 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.
Time frame: From delivery until discharge from the hospital, up to 30 days of age
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