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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

This study is not yet open for participant recruitment.
Verified December 2012 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01360034
First received: May 20, 2011
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Obstetric Labor, Premature
 Drug: Nifedipine
Drug: Indomethacin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Childbirth
U.S. FDA Resources

Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of preterm labour (before 35 weeks). [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 216
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nifedipine
108 patients will receive nifedipine as tocolytic for 48 hours.
 Drug: Nifedipine
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
Experimental: Indomethacin
108 patients will receive indomethacin as tocolytic 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360034

Contacts
Contact: Jorge Espinosa, Resident bobbyone-79@hotmail.com
Contact: Osvaldo Reyes, MD oreyespanama@yahoo.es

Locations
Panama
Saint Thomas Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Jorge Espinosa, Resident Saint Thomas Hospital, Panama
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01360034     History of Changes
Other Study ID Numbers: MHST2011-04
Study First Received: May 20, 2011
Last Updated: December 3, 2012
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Obstetric labor, premature
Short cervix
Nifedipine
Indomethacin

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Nifedipine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cardiovascular Agents
Central Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013