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Main
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Note: This record shows only 22 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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11 April 2016 |
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Main ID: |
NCT02363348 |
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Date of registration:
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27/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of L Arginine to Prevent Preeclampsia
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Scientific title:
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Efficacy and Safety of L Arginine to Prevent Preeclampsia in High Risk Pregnancies |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02363348 |
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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: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Guadalupe Panduro, Ph |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Civil Juan I. Menchaca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- one or more risk factors for developing preeclampsia (nulliparous, previous history
of preeclampsia, chronic hypertension, BMI =30)
Exclusion Criteria:
- pregnant women carriers of chronic renal failure
- pre gestational diabetes
- multiple pregnancy and were removed for some reason they received medication that
would interfere with the interpretation of results (aspirin)
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preeclampsia
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Intervention(s)
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Dietary Supplement: L arginine
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Other: Placebo
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Primary Outcome(s)
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efficacy of L arginine to prevent preeclampsia
[Time Frame: from time of randomization until the date of diagnostic of preeclampsia or two weeks after delivery wichever came first. approximalety 20 weeks.]
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Secondary Outcome(s)
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perinatal outcome
[Time Frame: from time to delivery until two weeks after, approximalety 18 weeks]
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safety of L arginine
[Time Frame: from time of randomization until birth approximalety 18 weeks]
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Secondary ID(s)
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SSJ1054-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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