Status:
TERMINATED
Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
University Hospital
Conditions:
Premature Birth
Premature Labor
Eligibility:
FEMALE
15-50 years
Phase:
NA
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 bet...
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 gestati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00306462
Start Date
March 1 2006
End Date
October 1 2009
Last Update
November 9 2009
Active Locations (1)
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1
University Hospital
Cincinnati, Ohio, United States, 45219