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

• 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: Stanford University
• Information provided by (Responsible Party): Yasser Yehia El-Sayed, Stanford University

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 16, 2005
• Results First Submitted Date: February 13, 2018
• Results First Posted Date: October 2, 2018
• Last Update Posted Date: November 19, 2018
• Study Start Date: April 1999
• Actual Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Magnesium Sulfate Versus Nifedipine for the Acute Tocolysis of Preterm Labor: A Prospective, Randomized Trial
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obstetric Labor, Premature

Intervention

• 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

• 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. doi: 10.1097/01.AOG.0000269048.06634.35.
• Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2015): 192
• Original Enrollment: Not Provided
• Actual Study Completion Date: July 2007
• Actual Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
• Eligibility Criteria: 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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00185900
• Other Study ID Numbers: 76145
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Yasser Yehia El-Sayed, Stanford University
• Original Responsible Party: Not Provided
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yasser Yehia El-Sayed; Stanford University

• PRS Account: Stanford University
• Verification Date: October 2018