Safety of Direct Oral Anticoagulant During Pregnancy

Thromboembolic Disease Clinical Trial

— SACOD  

Official title:

Safety of Direct Oral Anticoagulant During Pregnancy - Pregnancy, Neonatal and Infant Outcome: a National-based Study From the French Claim Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179823
• Other study ID #: SACOD
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1755558
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 60 Years

Eligibility

Inclusion Criteria:

• pregnant women exposed to an anticoagulant

Exclusion Criteria:

• women not covered by national health insurrance

Related Conditions & MeSH terms

• Thromboembolic Disease
• Thromboembolism

Locations

Country	Name	City	State
France	Nancy teaching hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse pregnancy outcome	at least one of the following events : miscarriage/aborption; termination of pregnancy,; stillbirth,; preterm birth,; death of a full-term newborn	during pregnancy
Primary	Complication	at least one of the following events : maternal complication (hemorrhage...); child malformation	from date of conception to the first year of child life