Trial record 2 of 426 for:    Open Studies | "Labor, Obstetric"

Nifedipine Versus Indomethacin in the Treatment of Preterm Labour

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2015 by Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama Identifier:
First received: May 20, 2011
Last updated: January 1, 2015
Last verified: January 2015
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:

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: December 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01360034

Contact: Jorge Espinosa, Resident
Contact: Osvaldo Reyes, MD

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

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama Identifier: NCT01360034     History of Changes
Other Study ID Numbers: MHST2011-04 
Study First Received: May 20, 2011
Last Updated: January 1, 2015
Health Authority: Panama: Ministry of Health

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

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Calcium Channel Blockers
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Tocolytic Agents
Vasodilator Agents processed this record on May 26, 2016