Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-03-31

Brief Summary

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In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures

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Detailed Description

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Conditions

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Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oral Nifedine

Group Type EXPERIMENTAL

Nifedlipine

Intervention Type DRUG

Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs

2

Intravenous Magnesium

Group Type ACTIVE_COMPARATOR

Magnesium

Intervention Type DRUG

Intravenous Magnesium 6 gram load, 3 grams/hr

Interventions

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Magnesium

Intravenous Magnesium 6 gram load, 3 grams/hr

Intervention Type DRUG

Nifedlipine

Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients between 240/7-320/7 weeks gestation with findings consistent with preterm labor defined by at least one of the following criteria in accordance with regular uterine contractions (\>4 uterine contractions in 20 minutes):

1. Cervix \> 2 cm in dilation or 80% effaced
2. Positive fetal fibronectin (if performed).
3. Demonstrated cervical change between two exams within 90 minutes.

Exclusion Criteria

* Negative fetal fibronectin
* \> 5cm dilatation
* Multiple gestations
* Known fetal anomalies or chromosomal abnormalities
* Ruptured membranes
* Significant vaginal bleeding
* Suspected chorioamnionitis
* Preeclampsia or uncontrolled hypertension
* Non-reassuring fetal heart tracing
* Placenta previa and/or accreta
* Placenta abruption
* Intrauterine growth restriction
* Maternal renal disease
* Underlying maternal cardiac condition
* Symptomatic hyperthyroidism
* Significant maternal disease
* Contraindication to nifedipine or magnesium
* Cerclage presence
* Tocolytic use within the last 12 hours
* Hypotension (defined as average blood pressure of \<70/40's unresponsive to 1000 cc fluid bolus

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No