Venous ThromboembolismNCT05066867
LMWH Compliance in Pregnancy
An observational study of Venous Thromboembolism and Antenatal Deep Vein Thrombosis, run by Cork University Maternity Hospital at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Antenatal Deep Vein Thrombosis
- What is being tested?
- Smart sharps bin - collects data on compliance
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2021to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Antenatal and postnatal women at higher risk of VTE, commenced on LMWH \& fitting the inclusion criteria
Who may be able to join
- current VTE
- previous history of VTE
- class III obesity
- history of placenta mediated complications
- pre-eclampsia
- Advanced Maternal Age
Show all 10Show fewer
- inherited thrombophilia
- prolonged immobilization
- varicose veins
- other risk factors that predispose them to VTE
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
Rebecca Cole, rebecca.cole@ucc.ie
Rebecca Cole
About this study
Official title: 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.
- Being tested
- Smart sharps bin - collects data on compliance
- Keywords
- Pregnancy thromboprophylaxis, LMWH compliance
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart sharps bin - collects data on complianceOther
collects compliance data
What is being measured
The primary outcome is the main question the study is designed to answer.
LMWH compliance levels in pregnancy
Compliance is described as a patient taking at least 80% of LMWH injections
Measured: 18 months
Secondary outcomes (1)
Sociodemographic factors
To determine sociodemographic factors that influence compliance
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cork University Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HealthBeacon ICMS
- Responsible party
- Principal investigator, John R Higgins, Cork University Maternity Hospital
- Investigators
- John RJ Higgins, M.D., Principal investigator, CUMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066867
- Sponsor's protocol ID
- CorkUMH
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Long-term Low-molecular-weight Heparin Prophylaxis/Treatment in the Anatenatal and Postnatal Population
- ClinicalTrials.gov ID
- NCT05066867
- Acronym / sponsor ID
- CorkUMH
- Keywords
- Pregnancy thromboprophylaxis, LMWH compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cork University Maternity HospitalUniversity, hospital or other
- Collaborators
- HealthBeacon ICMS
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Antenatal and postnatal women at higher risk of VTE, commenced on LMWH \& fitting the inclusion criteria
Key inclusion criteria (10 listed)
- current VTE
- previous history of VTE
- class III obesity
- history of placenta mediated complications
- pre-eclampsia
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart sharps bin - collects data on compliancecollects compliance data | Other | – |
Primary outcome
LMWH compliance levels in pregnancy
Time frame: 18 months
Compliance is described as a patient taking at least 80% of LMWH injections
1 secondary outcome
Sociodemographic factors
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John RJ Higgins, M.D. principal investigator
CUMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Antenatal Deep Vein Thrombosis, run by Cork University Maternity Hospital at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecca M Cole, M.B. (+353214920500, rebecca.cole@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LMWH compliance levels in pregnancy (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.