anti10a Levels in Women Treated With LMWH in the Postpartum Period

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02856295

Enrollment

136

Registered

2016-08-04

Start date

2021-11-20

Completion date

2022-08-01

Last updated

2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

postpartum venous thromboembolism, prophylactic dose of low molecular weight heparin, anti 10a

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.

Interventions

DRUGclexane (LMWH)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
clexane dosing method in order to achieve anti 10a level >0.2	4 hour after the women receive the drug

Secondary

Measure	Time frame
incidence of anti 10a level of >0.6	4 hour after the women receive the drug
incidence of vein thromboembolism	during the six weeks after delivery
incidence of bleeding events	during the six weeks after delivery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026