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

Labor, Premature Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00641784
• Other study ID #: 464-07
• Status: Terminated
• Phase: Phase 3
• First received: March 19, 2008
• Last updated: September 17, 2009
• Start date: March 2008
• Est. completion date: March 2012

Study information

• Verified date: September 2009
• Source: MemorialCare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor, Premature
• Obstetric Labor, Premature

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Care Center for Women/Long Beach Memorial Medical Center	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
MemorialCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess the efficacy of nifedipine versus intravenous magnesium in prolonging pregnancy in patients presenting with strict criteria of preterm labor.		At Delivery	No
Secondary	To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate.		At delivery	No
Secondary	To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis		At discharge	No