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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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6 November 2023 |
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Main ID: |
NCT02303171 |
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Date of registration:
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25/11/2014 |
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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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Use of Warfarin After the First Trimester in Pregnant Women With APS
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Scientific title:
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Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02303171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohamed I Eid, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mohamed I Eid, Dr |
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Address:
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Telephone:
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+201225401274 |
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Email:
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dr_moh_eid@yahoo.com |
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Affiliation:
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Name:
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Abdelmageed F Mashaly, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Name:
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Mohamed I Eid, Dr |
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Address:
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Telephone:
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+201225401274 |
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Email:
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dr_moh_eid@yahoo.com |
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Affiliation:
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Name:
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Mohamed S Abdelhafez, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mansoura University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant women with APS diagnosed according to the revised classification criteria for
APS in 2006 in Sydney, Australia
- Early pregnancy body weight is 50-90 Kg
Exclusion Criteria:
- Women with systemic lupus erythematosus (SLE)
- Women with active thromboembolic disorders
- Women with history of previous thromboembolic disorders
Age minimum:
20 Years
Age maximum:
38 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Antiphospholipid Syndrome
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Recurrent Miscarriage
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Intervention(s)
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Drug: Warfarin
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Drug: Enoxaparin
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Primary Outcome(s)
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Fetal loss
[Time Frame: From 12 weeks to 42 weeks gestational age]
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Secondary Outcome(s)
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Preterm delivery
[Time Frame: From 20 weeks to 34 weeks gestational age]
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Congenital fetal malformations
[Time Frame: At birth]
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Intrauterine growth restriction (IUGR)
[Time Frame: At birth]
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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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