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临床试验/NCT05066867
NCT05066867Unknown不适用

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

Cork University Maternity Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
LMWH compliance levels in pregnancy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

LMWH compliance levels in pregnancy

时间窗: 18 months

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

次要结局

  • Sociodemographic factors(18 months)

研究者

发起方
Cork University Maternity Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

John R Higgins

Professor/Clinical Director

Cork University Maternity Hospital

研究点 (1)

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