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

Official Title: “A Randomized Trial of Oral Nifedipine Versus Intravenous Magnesium Sulfate in the Acute Management of Preterm Labor in Women With Singleton Gestations, Intact Fetal Membranes, and Positive Vaginal Fetal Fibronectin”

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

Intervention(s) in this Clinical Trial

• Drug: Magnesium
  • Intravenous Magnesium 6 gram load, 3 grams/hr
• Drug: Nifedlipine
  • Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Oral Nifedine
• Active Comparator: 2
  • Intravenous Magnesium

Primary Measures

• 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
  • Time Frame: At delivery
    Safety Issue?: Yes

Secondary Measures

• To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.
  • Time Frame: At Delivery
    Safety Issue?: No
• To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.
  • Time Frame: At delivery
    Safety Issue?: No
• To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis
  • Time Frame: At discharge
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: MemorialCare Other

Overall Clinical Trial Officials and Contacts

Kenneth Chan, MD Principal Investigator Obstetrix/Memorial Care  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641784

Study ID Number: 464-07

ClinicalTrials.gov Identifier: NCT00641784

Health Authority: United States: Institutional Review Board