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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 December 2012 |
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Main ID: |
NCT01360034 |
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Date of registration:
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20/05/2011 |
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Primary sponsor: |
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Public title:
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Nifedipine Versus Indomethacin in the Treatment of Preterm Labour
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Scientific title:
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Nifedipine vs. Indomethacin in the Treatment of Preterm Labour and Short Cervix. A Randomized, Controlled Trial. |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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216 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01360034 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Panama
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Contacts
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Name:
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Jorge Espinosa, Resident |
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Address:
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Telephone:
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Email:
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bobbyone-79@hotmail.com |
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Affiliation:
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Name:
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Jorge Espinosa, Resident |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Thomas Hospital, Panama |
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Name:
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Osvaldo Reyes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Thomas Hospital, Panama |
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Key inclusion & exclusion criteria
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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).
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obstetric Labor, Premature
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Intervention(s)
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Drug: Indomethacin
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Drug: Nifedipine
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Primary Outcome(s)
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Reduction of preterm birth (before 48 hours, allowing use of corticosteroids).
[Time Frame: 36 months]
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Secondary Outcome(s)
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Adverse effects
[Time Frame: 48 months]
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Reduction of preterm labour (before 35 weeks).
[Time Frame: 48 months]
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Secondary ID(s)
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MHST2011-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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