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
|Condition or disease||Intervention/treatment||Phase|
|Obstetric Labor, Premature||Drug: Nifedipine Drug: Indomethacin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
108 patients will receive nifedipine as tocolytic for 48 hours.
Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
108 patients will receive indomethacin as tocolytic for 48 hours.
Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
- Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ]
- 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.
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, Residentfirstname.lastname@example.org|
|Contact: Osvaldo Reyes, MDemail@example.com|
|Saint Thomas Hospital|
|Principal Investigator:||Jorge Espinosa, Resident||Saint Thomas Hospital, Panama|
|Principal Investigator:||Osvaldo Reyes, MD||Saint Thomas Hospital, Panama|