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

MemorialCare

Status and phase

Terminated

Phase 3

Conditions

Labor, Premature

Treatments

Drug: Nifedlipine

Drug: Magnesium

Study type

Interventional

Funder types

Other

Identifiers

NCT00641784

464-07

Details and patient eligibility

About

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

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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