LMWH Compliance in Pregnancy

NCT05066867 | Unknown

• 1 other identifier: CorkUMH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Antenatal Deep Vein Thrombosis

Keywords

Pregnancy thromboprophylaxis; LMWH compliance

Outcome Measures

Primary Outcomes (1)

• LMWH compliance levels in pregnancy

  Compliance is described as a patient taking at least 80% of LMWH injections

  18 months

Secondary Outcomes (1)

• Sociodemographic factors

  18 months

Interventions

Smart sharps bin - collects data on compliance OTHER

collects compliance data

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Antenatal and postnatal woman at higher risk of VTE commenced on LMWH thromboprophylaxis fitting the inclusion criteria
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cork University Maternity Hospital: lead
• HealthBeacon ICMS: collaborator

Study Sites (1)

Cork University Maternity Hospital

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• John RJ Higgins, M.D.

  CUMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca M Cole, M.B.

CONTACT

+353214920500; rebecca.cole@ucc.ie

John RJ Higgins, M.D.

CONTACT

+353214920749; j.higgins@ucc.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/Clinical Director

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

IE (1)