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

Not Applicable

Completed

• Conditions: Obstetric Labor, Premature
• Interventions: Drug: Magnesium Sulfate; Drug: Nifedipine

• Registration Number: NCT00185900
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Study Completion: 2007-07
• Results First Submitted: 2018-02-13
• Results First Submitted QC: 2018-02-13
• Status Verified: 2018-10
• Results First Posted: 2018-10-02
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium Sulfate	Magnesium Sulfate	Preterm labor treatment with Magnesium Sulfate.
Nifedipine	Nifedipine	Preterm labor treatment with Nifedipine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Prevention of Preterm Delivery for 48 Hours With Attainment of Uterine Quiescence	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

Name	Time	Method
Gestational Age at Delivery	Until delivery, up to 42 weeks of gestation	Presented as weeks
Serious Maternal Adverse Effect	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.
Time to Uterine Quiescence	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.
Neonatal Birth Weight	Until delivery, up to 42 weeks of gestation	Presented as grams
Composite Neonatal Morbidity	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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States