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

This study has been terminated.
Sponsor:
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00641784
First received: March 19, 2008
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Labor, Premature
 Drug: Magnesium
Drug: Nifedlipine
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Magnesium
U.S. FDA Resources

Further study details as provided by MemorialCare:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate. [ Time Frame: At delivery ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Nifedine
 Drug: Nifedlipine
Oral Nifedpine 10 mgs q 20 min to effect (max 40mgs)...then 20 mgs q 4hrs
Active Comparator: 2
Intravenous Magnesium
 Drug: Magnesium
Intravenous Magnesium 6 gram load, 3 grams/hr

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641784

Locations
United States, California
Memorial Care Center for Women/Long Beach Memorial Medical Center
Long Beach, California, United States, 92806
Sponsors and Collaborators
MemorialCare
Investigators
Principal Investigator: Kenneth Chan, MD Obstetrix/Memorial Care
Principal Investigator: Vineet K Shrivastava, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Kenneth Chan, Obstetrix (Magella)
ClinicalTrials.gov Identifier: NCT00641784     History of Changes
Other Study ID Numbers: 464-07
Study First Received: March 19, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Composite Early neonatal Outcome
Late Neurological neonatal outcome

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013