Safety of Direct Oral Anticoagulant During Pregnancy (SACOD)

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

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.

Study Overview

• Status: Completed
• Conditions: Thromboembolic Disease

• Study Type: Observational
• Enrollment (Actual): 1755558

Contacts and Locations

Study Locations

• France
  • Nancy, France, 5400
    • Nancy teaching hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• pregnant women exposed to an anticoagulant

Exclusion Criteria:

• women not covered by national health insurrance

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism
• Other Study ID Numbers: SACOD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No