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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360034
First Posted: May 25, 2011
Last Update Posted: January 5, 2015
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 (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
May 20, 2011
May 25, 2011
January 5, 2015
December 2015
May 2016   (Final data collection date for primary outcome measure)
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ]
Same as current
Complete list of historical versions of study NCT01360034 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obstetric Labor, Premature
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
216
June 2016
May 2016   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Panama
 
 
NCT01360034
MHST2011-04
No
Not Provided
Not Provided
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
January 2015

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