Clinical trial NCT06179823: Safety of Direct Oral Anticoagulant During Pregnancy
Official title: Safety of Direct Oral Anticoagulant During Pregnancy - Pregnancy, Neonatal and Infant Outcome: a National-based Study From the French Claim Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboembolic Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 1755558
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women with an pregnancy outcome identified in the French nationwide claim database (SNDS) exposed to anticoagulation treatment

Brief summary: Pregnancy is a major risk factor of thromboembolic disease (2 to 10 increased risk of thromboembolic event for pregnant women). This risk is related to the physiological changes inducing venous stasis and hypercoagulability.

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.


Eligibility criteria: Inclusion Criteria:

* pregnant women exposed to an anticoagulant

Exclusion Criteria:

* women not covered by national health insurrance

Primary outcomes:
measure: Adverse pregnancy outcome
timeFrame: during pregnancy
measure: Complication
timeFrame: from date of conception to the first year of child life
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy teaching hospital
Study officials:
References: