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Completed

NCT Number: NCT02856295

anti10a Levels in Women Treated With LMWH in the Postpartum Period

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

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Emek medical center

Afula, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

clexane (LMWH)

Drug

to compare tow doses of clexane for preventing VTE in postpartum women

Primary outcomes

  1. clexane dosing method in order to achieve anti 10a level >0.2

    Time frame: 4 hour after the women receive the drug

Secondary outcomes

  1. incidence of anti 10a level of >0.6

    Time frame: 4 hour after the women receive the drug

  2. incidence of vein thromboembolism

    Time frame: during the six weeks after delivery

  3. incidence of bleeding events

    Time frame: during the six weeks after delivery

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 4, 2016
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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