Use of Warfarin After the First Trimester in Pregnant Women With APS

Mohamed Sayed Abdelhafez

Status and phase: Enrolling; Phase 4

Conditions: Antiphospholipid Syndrome; Recurrent Miscarriage

Treatments: Drug: Warfarin; Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02303171

MIE1

Details and patient eligibility

About

Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Full description

Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
• Early pregnancy body weight is 50-90 Kg

Exclusion criteria

• Women with systemic lupus erythematosus (SLE)
• Women with active thromboembolic disorders
• Women with history of previous thromboembolic disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Enoxaparin group

Active Comparator group

Description:

Women will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy

Treatment:

Drug: Enoxaparin

Warfarin group

Active Comparator group

Description:

Women will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester

Treatment:

Drug: Warfarin