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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

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ClinicalTrials.gov Identifier: NCT01360034
Recruitment Status : Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Not yet recruiting
First Posted : May 25, 2011
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE May 25, 2011
Last Update Posted Date January 5, 2015
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2011)
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01360034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2011)
  • Reduction of preterm labour (before 35 weeks). [ Time Frame: 48 months ]
  • Adverse effects [ Time Frame: 48 months ]
    To determine the frequency of maternal adverse effects related to the use of both drugs (nifedipine and indomethacin). These include the development of any type of rash, nausea, weakness/hypotension, headache, dyspepsy or bleeding disorders of any kind.
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 Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Official Title  ICMJE Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Brief Summary The purpose of this study was to compare the effectiveness of nifedipine versus indomethacin as tocolytic for the treatment of preterm labour with short cervix (< 2.5cms).
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 Obstetric Labor, Premature
Intervention  ICMJE
  • Drug: Nifedipine
    Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
  • Drug: Indomethacin
    Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
Study Arms  ICMJE
  • Experimental: Nifedipine
    108 patients will receive nifedipine as tocolytic for 48 hours.
    Intervention: Drug: Nifedipine
  • Experimental: Indomethacin
    108 patients will receive indomethacin as tocolytic for 48 hours.
    Intervention: Drug: Indomethacin
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 24, 2011)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnant women between 24 and 34 weeks of gestation.
  • Cervical length (determined by transvaginal ultrasound) of 2.5 cms or less

Exclusion Criteria:

  • All contraindications for tocolysis (fetal distress, abruptio placenta).
  • Multiple pregnancy.
  • All contraindications for the use of any of the two drugs (indomethacin or nifedipine).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01360034
Other Study ID Numbers  ICMJE MHST2011-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Study Sponsor  ICMJE Saint Thomas Hospital, Panama
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
PRS Account Saint Thomas Hospital, Panama
Verification Date January 2015

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