LMWH Compliance in Pregnancy

Sponsor

Cork University Maternity Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05066867

Collaborator

HealthBeacon ICMS (Other)

100

Enrollment

Location

14.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Antenatal Deep Vein Thrombosis	Other: Smart sharps bin - collects data on compliance

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

LMWH compliance levels in pregnancy [18 months]
Compliance is described as a patient taking at least 80% of LMWH injections

Secondary Outcome Measures

Sociodemographic factors [18 months]
To determine sociodemographic factors that influence compliance

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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