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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
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Obstetric Labor, Premature Drug: Nifedipine Drug: Indomethacin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial.
Study Start Date : December 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Reduction of preterm labour (before 35 weeks). [ Time Frame: 48 months ]
  2. 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.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360034

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

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
ClinicalTrials.gov Identifier: NCT01360034     History of Changes
Other Study ID Numbers: MHST2011-04
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Obstetric labor, premature
Short cervix

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