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

Phase 3

Terminated

• Conditions: Labor, Premature
• Interventions: Drug: Nifedlipine; Drug: Magnesium

• Registration Number: NCT00641784
• Lead Sponsor: MemorialCare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nifedlipine	Oral Nifedine
2	Magnesium	Intravenous Magnesium

Primary Outcome Measures

Name	Time	Method
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	At delivery

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.	At Delivery
To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.	At delivery
To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis	At discharge

Trial Locations

Locations (1)

Memorial Care Center for Women/Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States