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Trial record 91 of 144 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT00641784
Recruitment Status : Terminated
First Posted : March 24, 2008
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:
MemorialCare

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 24, 2008
Last Update Posted Date September 18, 2009
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00641784 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tocolytics Trial: Intravenous (IV) Magnesium Versus Oral Nifedpine in Fetal Fibronectin (FFN) Postive Population
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Labor, Premature
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Oral Nifedine
    Intervention: Drug: Nifedlipine
  • Active Comparator: 2
    Intravenous Magnesium
    Intervention: Drug: Magnesium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: March 21, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00641784
Other Study ID Numbers  ICMJE 464-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Chan, Obstetrix (Magella)
Study Sponsor  ICMJE MemorialCare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Chan, MD Obstetrix/Memorial Care
Principal Investigator: Vineet K Shrivastava, MD University of California, Irvine
PRS Account MemorialCare
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP