LMWH Compliance in Pregnancy

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066867
• Other study ID #: CorkUMH
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: September 2021
• Source: Cork University Maternity Hospital
• Contact: Rebecca M Cole, M.B.
• Phone: +353214920500
• Email: rebecca.cole[@]ucc.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• Smart sharps bin - collects data on compliance
collects compliance data

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Cork University Maternity Hospital	HealthBeacon ICMS

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LMWH compliance levels in pregnancy	Compliance is described as a patient taking at least 80% of LMWH injections	18 months
Secondary	Sociodemographic factors	To determine sociodemographic factors that influence compliance	18 months