Safety of Direct Oral Anticoagulant During Pregnancy

NCT06179823 | Completed

• 1 other identifier: SACOD
• Study Type: observational
• Target: 1,755,558
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboembolic Disease

Outcome Measures

Primary Outcomes (2)

• 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

• Complication

  at least one of the following events : * maternal complication (hemorrhage...) * child malformation

  from date of conception to the first year of child life

Study Arms (3)

DOAC direct oral anticoagulants

pregnant women exposed to doac

VKA vitamin K antagonist

pregnant women exposed to vitamin K antagonist

Heparin

pregnant women exposed to Heparin

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All women with an pregnancy outcome identified in the French nationwide claim database (SNDS) exposed to anticoagulation treatment

You may qualify if:

• pregnant women exposed to an anticoagulant

You may not qualify if:

• women not covered by national health insurrance

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nancy teaching hospital

Nancy, 5400, France

Location

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

FR (1)