The Feasibility of Employing Ambulatory Fetal Heart Rate Monitoring in Small for Gestational Age Fetuses at Risk of Stillbirth.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess recruitment rate to the study on first invitation
研究概览
简要总结
Most babies who measure small during pregnancy are born healthy. However, some are small because they are not growing as expected, usually because the placenta (the baby's 'life support' system) is not working properly. These babies are at greatly increased risk of dying before birth, and need to be delivered before they become poorly.
Scans and electronic heartrate monitoring are currently used to monitor these babies. But they can only be used for short periods and don't always provide enough information to show when to deliver the baby.
A small light monitor has been developed that safely records the baby's heart rate for up to 16hrs by measuring electrical activity through sticky patches on the mum's skin (like a normal ECG). The woman carries on with her daily activities while wearing it. Monitoring the heart rate over a longer time may help with decisions about the timing of the delivery and could prevent stillbirth, the aim of our future study. This will include large numbers of women carrying small babies. Before the investigators can do this the investigators need to know whether:
- Wearing the monitor for 16hrs is practical and acceptable to pregnant women
- The monitor can provide useful information on the baby's heart rate at different stages of pregnancy.
Thirty pregnant women whose babies are measuring small will be asked to wear the monitor on two occasions, for 16hrs each time. The women will describe what they think about wearing the monitor by completing questionnaires.
The data from the monitor will be downloaded and compared with the woman's medical notes after the participant has delivered her baby. Results from this study will be publicised and will help with the design of the investigators future study into the usefulness of this monitor.
详细描述
Study design:
The study has been designed as a prospective, non randomised, single centre feasibility study to determine the acceptability and reliability of the Monica AN24 device, as a method of long-term fetal heart rate (FHR) monitoring on more than one occasion in the antenatal period.
Objectives of the study:
The proposed feasibility study aims to:
- Assess the recruitment rates and practicality of the study design and protocol.
- Evaluate the acceptability to participants of wearing the device for overnight FHR monitoring on two occasions in pregnancy.
- Measure the success rate of generating good quality overnight FHR data and identify any limitations of the technique.
- Determine response rates to questionnaires
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women with singleton pregnancy from 28 completed weeks of gestation, suspected to carry small for gestational age (SGA) fetus on ultrasound scan but with no known congenital abnormality will be eligible for inclusion in the study if they agree.
排除标准
- •Evidence of a major fetal malformation on ultrasound scan
- •Clinical suspicion of labour
- •Multiple pregnancy
- •Involved in another study using a device or medicinal product
结局指标
主要结局
To assess recruitment rate to the study on first invitation
时间窗: one year
To estimate proportion of recruited women who demonstrate willingness to wear the monitor two times
时间窗: one year
In light of investigator's previous work, no problems are anticipated in achieving 30 recruits in a year. However, study would be deemed successful if at least 80% of participants wear the monitor on second occasion and complete the study
次要结局
- To measure success rate of fetal heart rate data across different stages of pregnancy(one year)
研究者
Habiba Kapaya
Clinical Lecturer
Sheffield Teaching Hospitals NHS Foundation Trust