anti10a Levels in Women Treated With LMWH in the Postpartum Period

November 10, 2022 updated by: Zohar Nachum, HaEmek Medical Center, Israel

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Emek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: clexane according to weight group
clexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg.
Drug: clexane (LMWH)
to compare tow doses of clexane for preventing VTE in postpartum women
Active Comparator: clexane mg per kg
clexane dose of 1mg/kg up to 120 mg
Drug: clexane (LMWH)
to compare tow doses of clexane for preventing VTE in postpartum women

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Study Director: Zohar Nachum, M.D, Emek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMC59-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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