Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1755558 participants
OBSERVATIONAL
2019-01-01
2020-12-31
Brief Summary
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Thromboembolic disease is the first preventable cause of death during pregnancy (in France 1.1 maternal death per 100 000 living births.
The recommended treatment for pregnant women is low molecular weight heparin requiring subcutaneous injections daily. Vitamin K antagonists are contraindicated due to a teratogenic risk. Direct oral anticoagulants (DOAC) are easier to use.
Currently available preclinical and incidental exposure data on DOAC in pregnant women are very limited and insufficient to conclude on their safety. Therefore, its use during pregnancy is currently contraindicated for the grounds of precaution. The use of reimbursement data from the Système National des données de santé (National Health Data System) would provide more information on accidental exposure to DOACs during pregnancy, thanks to its completeness.
The primary objective of SACOD is to compare the prevalence of adverse perinatal outcomes in pregnant women treated with a direct oral anticoagulant versus pregnant women treated with heparin and Vitamin K antagonist.
The secondary objectives of the SACOD study are to i) determine the frequency of patients exposed to a direct oral anticoagulant during pregnancy according to pregnancy, ii) measure the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with a direct oral anticoagulant therapy, iii) compare the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with direct oral anticoagulants compared with pregnant women treated with heparin and a vitamin K antagonist, iv) compare the prevalence of adverse perinatal outcomes in pregnant women with Antiphospholipid syndrome treated with a direct oral anticoagulant versus pregnant women treated with heparin and anti-vitamin K, v) measure the incidence of thrombo-embolic episodes during pregnancy under anticoagulant treatment.
Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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DOAC direct oral anticoagulants
pregnant women exposed to doac
No interventions assigned to this group
VKA vitamin K antagonist
pregnant women exposed to vitamin K antagonist
No interventions assigned to this group
Heparin
pregnant women exposed to Heparin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
10 Years
60 Years
FEMALE
Yes
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Aurélie BANNAY
MD
Locations
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Nancy teaching hospital
Nancy, , France
Countries
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Other Identifiers
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SACOD
Identifier Type: -
Identifier Source: org_study_id