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

Obstetric Labor, Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185900
• Other study ID #: 76145
• Status: Completed
• Phase: N/A
• Start date: April 1999
• Est. completion date: July 2007

Study information

• Verified date: October 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence	Uterine quiescence defined by 12 hours of six or fewer contractions per hour and no further cervical change within 48 hours of tocolytic initiation.	48 hours after administration of study medication.
Secondary	Time to Uterine Quiescence	Uterine quiescence was defined by 12 hours of six of fewer contractions per hour and no further cervical change.	Until delivery, up to 42 weeks of gestation
Secondary	Gestational Age at Delivery	Presented as weeks	Until delivery, up to 42 weeks of gestation
Secondary	Neonatal Birth Weight	Presented as grams	Until delivery, up to 42 weeks of gestation
Secondary	Serious Maternal Adverse Effect	A composite of any of the following: chest pain, pulmonary edema, shortness of breath or hypotension.	From study enrollment until discharge from delivery hospital, up to 30 days after delivery.
Secondary	Composite Neonatal Morbidity	Defined as any of the following: respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, sepsis or fetal/neonatal death.	From delivery until discharge from the hospital, up to 30 days of age

External Links

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