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
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Sponsor:
Saint Thomas Hospital, Panama
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Tracking Information | |||||||
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First Submitted Date ICMJE | May 20, 2011 | ||||||
First Posted Date ICMJE | May 25, 2011 | ||||||
Last Update Posted Date | January 5, 2015 | ||||||
Study Start Date ICMJE | December 2015 | ||||||
Estimated Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Reduction of preterm birth (before 48 hours, allowing use of corticosteroids). [ Time Frame: 36 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01360034 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Nifedipine Versus Indomethacin in the Treatment of Preterm Labour | ||||||
Official Title ICMJE | Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial. | ||||||
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). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Obstetric Labor, Premature | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
216 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 2016 | ||||||
Estimated Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Panama | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01360034 | ||||||
Other Study ID Numbers ICMJE | MHST2011-04 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Osvaldo A. Reyes T., Saint Thomas Hospital, Panama | ||||||
Study Sponsor ICMJE | Saint Thomas Hospital, Panama | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Saint Thomas Hospital, Panama | ||||||
Verification Date | January 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |