Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor
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|ClinicalTrials.gov Identifier: NCT00306462|
Recruitment Status : Terminated (No enrollment in past year, lack of interest)
First Posted : March 23, 2006
Last Update Posted : November 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth Premature Labor||Drug: Magnesium sulfate Drug: Oral Nifedipine or placebo||Not Applicable|
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.
- To compare maternal side effects between the two tocolytic agents
- To compare neonatal morbidities between the two study groups.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Active Comparator: 1
Intravenous magnesium sulfate or placebo
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.
Active Comparator: 2
Oral nifedipine or placebo
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.
Other Name: Oral procardia
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00306462
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Baha Sibai, MD||University of Cincinnati|