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 |
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.
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.
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
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