Timing of Initiation of LMWH Administration in Pregnant Women With APS

Mohamed Sayed Abdelhafez

Status and phase: Completed; Phase 4

Conditions: Antiphospholipid Syndrome; Recurrent Miscarriage

Treatments: Drug: Enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02326051

MIE2

Details and patient eligibility

About

Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Full description

Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy

Enrollment: 100 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: Single Blind

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100 participants in 2 patient groups

Early Enoxaparin initiation

Active Comparator group

Description:

Women will start Enoxaparin therapy once positive pregnancy test is established

Treatment:

Drug: Enoxaparin

Drug: Enoxaparin

Later Enoxaparin initiation

Active Comparator group

Description:

Women will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation

Treatment:

Drug: Enoxaparin

Drug: Enoxaparin