Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
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|ClinicalTrials.gov Identifier: NCT00185900|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 2, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Labor, Premature||Drug: Magnesium Sulfate Drug: Nifedipine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2007|
Active Comparator: Magnesium Sulfate
Preterm labor treatment with Magnesium Sulfate.
Drug: Magnesium Sulfate
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.
Active Comparator: Nifedipine
Preterm labor treatment with Nifedipine.
Preterm labor treatment with Nifedipine 10 mg. sublingually every 20 minutes for three doses, followed by 20 mg. orally every 4 or 6 hours.
- Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence [ Time Frame: 48 hours after administration of study medication. ]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 to Uterine Quiescence [ Time Frame: Until delivery, up to 42 weeks of gestation ]Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.
- Gestational Age at Delivery [ Time Frame: Until delivery, up to 42 weeks of gestation ]Presented as weeks
- Neonatal Birth Weight [ Time Frame: Until delivery, up to 42 weeks of gestation ]Presented as grams
- Serious Maternal Adverse Effect [ Time Frame: From study enrollment until discharge from delivery hospital, up to 30 days after delivery. ]A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.
- Composite Neonatal Morbidity [ Time Frame: From delivery until discharge from the hospital, up to 30 days of age ]Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.
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): NCT00185900
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Yasser Yehia El-Sayed||Stanford University|