anti10a Levels in Women Treated With LMWH in the Postpartum Period

HaEmek Medical Center, Israel

Status and phase: Completed; Phase 4

Conditions: Venous Thromboembolism

Treatments: Drug: clexane (LMWH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02856295

EMC59-12

Details and patient eligibility

About

The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg

Full description

pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.

This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.

This study will compare between two protocols based on anti-10a levels.

Enrollment: 136 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• postpartum women supposed to receive LMWH according to obstetric indications

Exclusion criteria

• known allergy to clexane
• active bleeding postpartum
• thrombocytopenia < 75000
• recent cerebrovascular accident / transient ischemic attack (<4 weeks)
• glomerular filtration rate) < 30 ml/min)
• active liver disease
• malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

clexane according to weight group

Active Comparator group

Description:

clexane dose adjusted for woman's weight according to: weight \< 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, \>170kg-100mg.

Treatment:

Drug: clexane (LMWH)

clexane mg per kg

Active Comparator group

Description:

clexane dose of 1mg/kg up to 120 mg

Treatment:

Drug: clexane (LMWH)