Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360034
|Contact: Jorge Espinosa, Residentemail@example.com|
|Contact: Osvaldo Reyes, MDfirstname.lastname@example.org|
|Saint Thomas Hospital|
|Principal Investigator:||Jorge Espinosa, Resident||Saint Thomas Hospital, Panama|
|Principal Investigator:||Osvaldo Reyes, MD||Saint Thomas Hospital, Panama|