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

University of Cincinnati

Status: Terminated

Conditions: Premature Labor; Premature Birth

Treatments: Drug: Oral Nifedipine or placebo; Drug: Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00306462

05-12-27-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

1

Active Comparator group

Description:

Intravenous magnesium sulfate or placebo

Treatment:

Drug: Magnesium sulfate

2

Active Comparator group

Description:

Oral nifedipine or placebo

Treatment:

Drug: Oral Nifedipine or placebo