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

Study Description

Brief Summary:

To compare intravenous magnesium sulfate to oral nifedipine for acute tocolysis of preterm labor

Condition or disease	Intervention/treatment	Phase
Obstetric Labor, Premature	Drug: Magnesium Sulfate; Drug: Nifedipine	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. Gestational Age at Delivery [ Time Frame: Until delivery, up to 42 weeks of gestation ]
   Presented as weeks
3. Neonatal Birth Weight [ Time Frame: Until delivery, up to 42 weeks of gestation ]
   Presented as grams
4. 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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford University School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

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

More Information

Additional Information:

Obstet Gynecol. 2007 Jul;110(1):61-7. 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yasser Yehia El-Sayed, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT00185900
• Other Study ID Numbers: 76145
• First Posted: September 16, 2005
• Results First Posted: October 2, 2018
• Last Update Posted: November 19, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Magnesium Sulfate; Nifedipine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents; Vasodilator Agents