LMWH Compliance in Pregnancy

Compliance With Long-term Low-molecular-weight Heparin Prophylaxis/Treatment in the Anatenatal and Postnatal Population

This is a prospective chart study that will aim to assess objective data on compliance levels to low molecular weight heparin (LMWH) injections among pregnant and postnatal women undergoing VTE thromboprophylaxis treatment at Cork University Maternity Hospital. This is a study that will help shine light on accurate data for compliance and possible factors affecting it, which will be useful for more individualised treatment plans for future patients. Patients at higher risk of Venous thromboembolism undergoing VTE thromboprophylaxis will be invited to participate in the study. Once the patient reads the information leaflet and signs consent, data will then be collected from the patients medical record. The patient will be given a smart sharps bin with an individual, unique product code. This device will be provided by HealthBeacon, a Dublin based start-up company. The device will be personalised with the treatment schedule pre-loaded onto it. When a used LMWH injection is disposed into the smart sharps bin, an infrared sensor is activated. The system captures an image of the injection in the chamber before moving it to the normal 'sharps' container of the bin for disposal. The captured image is time-stamped and sent to HealthBeacon's electronic database. HealthBeacon will only have the data pertaining to the disposal of injections for each sharps bin (i.e. the timing of the disposal of each used injection in each pre-coded bin). We are blinded to the compliance information and will only will receive the raw Data once treatment is completed. Data will be analysed to determine compliance of LMWH injections. This study will enable us to have a better insight on accurate compliance rates for LMWH injections in pregnant women at higher risk for venous thromboembolism (VTE). Understanding compliance with LMWH injections and the factors which can affect it, will hopefully guide future information and education that we offer to patients who are prescribed LMWH injections and help decrease maternal mortality rates in future.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism; Antenatal Deep Vein Thrombosis
• Intervention / Treatment: Other: Smart sharps bin - collects data on compliance

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Rebecca M Cole, M.B.; Phone Number: +353214920500; Email: rebecca.cole@ucc.ie
• Study Contact Backup: Name: John RJ Higgins, M.D.; Phone Number: +353214920749; Email: j.higgins@ucc.ie

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • Cork University Maternity Hospital
    • Contact: Rebecca Cole; Email: rebecca.cole@ucc.ie
    • Sub-Investigator: Rebecca Cole
    • Sub-Investigator: Fergus McCarthy
    • Sub-Investigator: Karthika Annamalai
    • Sub-Investigator: Ali Khashan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Antenatal and postnatal women at higher risk of VTE, commenced on LMWH & fitting the inclusion criteria

Description

Inclusion Criteria:

• current VTE
• previous history of VTE
• class III obesity
• history of placenta mediated complications
• pre-eclampsia
• Advanced Maternal Age
• inherited thrombophilia
• prolonged immobilization
• varicose veins
• other risk factors that predispose them to VTE

Exclusion Criteria:

• life-long anti-coagulation
• mechanical heart valves
• other forms of injectable therapy for other illnesses
• long-term severe physical disability affecting mobility (eg: paraplegia, paralysis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LMWH compliance levels in pregnancy	Compliance is described as a patient taking at least 80% of LMWH injections	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic factors	To determine sociodemographic factors that influence compliance	18 months

Collaborators and Investigators

• Sponsor: Cork University Maternity Hospital
• Collaborators: HealthBeacon ICMS
• Investigators: Principal Investigator: John RJ Higgins, M.D., CUMH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy thromboprophylaxis; LMWH compliance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: CorkUMH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No