The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.
研究概览
简要总结
The overall aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to both pregnant women and HCPs.
50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Women aged ≥18 years
- •Gestational age 32+0 weeks onwards.
- •Singleton pregnancy.
- •Able to speak English
- •Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 6 index conditions (hypertensive disease in pregnancy, reduced fetal growth (small for gestational age and fetal growth restriction) obstetric cholestasis, PPROM, previous history of stillbirth and recurrent reduced fetal movements )
- •Able to give written informed consent.
- •Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.
排除标准
- •Multiple pregnancy.
- •Fetal abnormalities or a non-viable fetus.
- •Body mass index (BMI) ≥35
- •Women with internal cardiac devices such as pacemaker and implantable cardioverter defibrillator.
- •History of allergic reaction to skin adhesives and/or latex.
- •Acute or chronic skin lesions and wounds in areas in contact with the device.
结局指标
主要结局
The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring.
时间窗: Through study completion, an average of 9 months
Completion of an at least 20 minutes of uninterrupted interpretable fetal heart recording which has computerised capability. This will be defined as a percentage derived from the number of monitoring episodes achieving the primary outcome divided by the total number of monitoring episodes.
次要结局
- The number of participants completing the full schedule of home maternal-fetal monitoring episodes.(Through study completion, an average of 9 months)
- The number of women approached who agreed to participate within the study.(Pre-intervention)
- What are the emotions of participants using home maternal-fetal monitoring.(Pre-intervention)
- What are the emotions of participants using home maternal-fetal monitoring and is there an impact before and after a singular monitoring episode?(Through study completion, an average of 9 months)
- What are the emotions of participants using home maternal-fetal monitoring and was there any change from the beginning of the study.(Immediately after the intervention)
- The usability of the remote monitoring device.(Immediately after the end of the intervention)
- The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care.(Through study completion, an average of 9 months)
- What are the views of participants regarding acceptability of home maternal-fetal monitoring.(Immediately after the intervention)
- The influence of fetal movements on achieving the primary outcome(Through study completion, an average of 9 months)
- The influence of participant demographics on achieving the primary outcome.(Through study completion, an average of 9 months)
- Determining participant adherence to commencing the monitoring episodes(Through study completion, an average of 9 months)
研究者
Jack Hamer
Clinical research fellow
Birmingham Women's NHS Foundation Trust