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



Status:Terminated
Conditions:Women's Studies, Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:15 - 50
Updated:10/14/2017
Start Date:March 2006
End Date:October 2009

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Randomized Double-Blinded Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor Between 24 to 32 6/7 Weeks' Gestation

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.

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.

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
We found this trial at
1
site
Cincinnati, Ohio 45219
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from
Cincinnati, OH
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