Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

• ClinicalTrials.gov Identifier: NCT01360034
• Recruitment Status: Unknown
• First Posted: May 25, 2011
• Last Update Posted: January 5, 2015
• Sponsor: Saint Thomas Hospital, Panama
• Information provided by (Responsible Party): Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Tracking Information

• First Submitted Date: May 20, 2011
• First Posted Date: May 25, 2011
• Last Update Posted Date: January 5, 2015
• Study Start Date: December 2015
• Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 24, 2011): Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01360034 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obstetric Labor, Premature

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 24, 2011): 216
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2016
• Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Panama

Administrative Information

• NCT Number: NCT01360034
• Other Study ID Numbers: MHST2011-04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
• Study Sponsor: Saint Thomas Hospital, Panama
• Collaborators: Not Provided

Investigators

• 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