Premature Birth, Premature Labor
Conditions
Keywords
Premature Labor, Premature Birth, Magnesium sulfate, Nifedipine
Brief 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.
Interventions
DRUGMagnesium 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.
DRUGOral 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.
Sponsors
University Hospital
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.
Exclusion criteria
* Cervical dilatation of ≥ 6 cm * Maternal contraindication to tocolysis * Known fetal anomalies * Suspected chorioamnionitis * Nonreassuring fetal heart tracing * Vaginal bleeding due to placenta previa or abruptio placenta * Preterm premature rupture of membranes * Prolapsed membranes * Human immunodeficiency virus positive * Multiple gestation * Patients on procardia within 24 hours of po intake * Magnesium sulfate tocolysis prior to randomization * Patient refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity | 4 years and 9 months |
Countries
United States
Outcome results
None listed