Clinical trial NCT02856295: anti10a Levels in Women Treated With LMWH in the Postpartum Period
Official title: anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Keywords: postpartum venous thromboembolism
prophylactic dose of low molecular weight heparin
anti 10a
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: clexane dosing method in order to achieve anti 10a level >0.2
timeFrame: 4 hour after the women receive the drug
Secondary outcomes:
measure: incidence of anti 10a level of >0.6
timeFrame: 4 hour after the women receive the drug
measure: incidence of vein thromboembolism
timeFrame: during the six weeks after delivery
measure: incidence of bleeding events
timeFrame: during the six weeks after delivery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
Study officials:
affiliation: Emek Medical Center
name: Zohar Nachum, M.D
role: STUDY_DIRECTOR
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