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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641784
First Posted: March 24, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
MemorialCare
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

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 ]
  • To assess tolerance and side effects of nifedipine versus intravenous magnesium sulfate. [ Time Frame: At delivery ]
  • To compare the total cost of using nifedipine versus intravenous magnesium sulfate in an acute hospital setting for tocolysis [ Time Frame: At discharge ]

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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kenneth Chan, Obstetrix (Magella)
ClinicalTrials.gov Identifier: NCT00641784     History of Changes
Other Study ID Numbers: 464-07
First Submitted: March 19, 2008
First Posted: March 24, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

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

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