Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

Not Applicable

Terminated

• Conditions: Premature Birth; Premature Labor
• Interventions: Drug: Oral Nifedipine or placebo; Drug: Magnesium sulfate

• Registration Number: NCT00306462
• Lead Sponsor: University of Cincinnati

Brief Summary

Primary Hypothesis:

Acute tocolysis (48 hours) using oral nifedipine is more effective than intravenous magnesium sulfate in prolonging pregnancy in women with preterm labor with intact membranes between 24 and 32 6/7 weeks' gestation.

Detailed Description

Primary Objective:

To compare the efficacy of oral nifedipine versus IV magnesium sulfate on the rate of preterm delivery at \<37 weeks in women with preterm labor between 24 and 32 6/7 weeks gestation.

Secondary Objective:

1. To compare maternal side effects between the two tocolytic agents

2. To compare neonatal morbidities between the two study groups.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-23
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-06
• Last Update Posted: 2009-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

• Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old.

Exclusion Criteria

• Cervical dilatation of ≥ 6 cm
• Maternal contraindication to tocolysis
• Known fetal anomalies
• Suspected chorioamnionitis
• Nonreassuring fetal heart tracing
• Vaginal bleeding due to placenta previa or abruptio placenta
• Preterm premature rupture of membranes
• Prolapsed membranes
• Human immunodeficiency virus positive
• Multiple gestation
• Patients on procardia within 24 hours of po intake
• Magnesium sulfate tocolysis prior to randomization
• Patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Oral Nifedipine or placebo	Oral nifedipine or placebo
1	Magnesium sulfate	Intravenous magnesium sulfate or placebo

Primary Outcome Measures

Name	Time	Method
Delivery <37 weeks' gestation, Delivery <34 weeks' gestation, Delivery <32 weeks' gestation	4 years

Secondary Outcome Measures

Name	Time	Method
Maternal complications associated with each drugs. Neonatal morbidities associated with prematurity	4 years and 9 months

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States