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Safety of Fondaparinux as Post Partum Thromboprophylaxis

NCT04447378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-26

No results posted yet for this study

Summary

Venous thromboembolism (VTE) remains as one of leading causes of maternal morbidity and mortality, with postpartum period carries the greatest risk. Perinatal thromboprophylaxis is often administered based on risk-factor assessment. Low molecular weight heparin has a proven safety profile in obstetrics population, however its porcine derived content may lead to reduced uptake amongst certain religious groups. The investigators aimed to evaluate the safety of fondaparinux as an alternative postpartum thromboprophylaxis.

The investigators planned a prospective, single arm, open label study. Women who fulfilled the criteria for post natal thromboprophylaxis based on the 2015 RCOG guidelines were recruited. Each patient would receive subcutaneous injection of Fondaparinux, 2.5mg daily for 10 days. The investigators would conduct a telephone interview on day 10 post delivery and six week outpatient review in clinic.

Conditions

  • Thromboembolism in the Puerperium

Interventions

DRUG

Fondaparinux 2.5Mg/0.5Ml Inj Syr

post natal thromboprophylaxis

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Nor Azlin Mohamed Ismail, MBCHB, MMED · Faculty of Medicine, National University of Malaysia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04447378 on ClinicalTrials.gov