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Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185900
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : October 2, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Yasser Yehia El-Sayed, Stanford University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Results First Submitted Date  ICMJE February 13, 2018
Results First Posted Date  ICMJE October 2, 2018
Last Update Posted Date November 19, 2018
Study Start Date  ICMJE April 1999
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00185900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Official Title  ICMJE Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
Brief Summary To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstetric Labor, Premature
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: Magnesium Sulfate
    Preterm labor treatment with Magnesium Sulfate.
    Intervention: Drug: Magnesium Sulfate
  • Active Comparator: Nifedipine
    Preterm labor treatment with Nifedipine.
    Intervention: Drug: Nifedipine
Publications * Lyell DJ, Pullen K, Campbell L, Ching S, Druzin ML, Chitkara U, Burrs D, Caughey AB, El-Sayed YY. Magnesium sulfate compared with nifedipine for acute tocolysis of preterm labor: a randomized controlled trial. Obstet Gynecol. 2007 Jul;110(1):61-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2015)
192
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria::- Uterine contractions and cervical change or ruptured membranes in a preterm gestation Exclusion Criteria:- placental abruption, fetal distress, placenta previa, maternal medical contraindication to tocolysis
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00185900
Other Study ID Numbers  ICMJE 76145
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yasser Yehia El-Sayed, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yasser Yehia El-Sayed Stanford University
PRS Account Stanford University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP