Cardiotocography, High Risk, Pregnancy, Telemedicine, Telemonitoring
Conditions
Brief summary
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.
Interventions
Remote CTG device and online dashboard for remote pregnancy care
Sponsors
Birmingham Women's NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
50 participants split in one arm using the home CTG device. To detect a 20% difference in the mean anxiety scores pre- and post-study a sample size with a power of 90% (α =0.05), a sample size of 42 is required. 50 recruited women will allow for a 10% drop out rate.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of women approached who agreed to participate within the study. | Pre-intervention | Number participants agreeing out of total women approached |
| What are the emotions of participants using home maternal-fetal monitoring. | Pre-intervention | Pre-intervention questionnaire using the accredited STAI anxiety questionnaire. |
| 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 | Questionnaire using the accredited STAI anxiety questionnaire at several time points whilst using the home monitoring device. Results compared pre and post monitoring episode to determine a if there is a discriminative impact on anxiety scores whilst using the home monitoring device. Results will be displayed graphically and compared using P value. |
| 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 | Post-intervention questionnaire using the accredited STAI anxiety questionnaire. Results compared to the scores at the beginning of the study and demonstrated graphically and with a P value. |
| The usability of the remote monitoring device. | Immediately after the end of the intervention | Assessed post study using the validated system usability scale scoring questionnaire. |
| The number of participants completing the full schedule of home maternal-fetal monitoring episodes. | Through study completion, an average of 9 months | Determined as the median number of monitoring episodes completed. |
| What are the views of participants regarding acceptability of home maternal-fetal monitoring. | Pre-intervention | Pre-intervention questionnaire using a 5 point Likert Scale (range from Strongly agree on the left, to strongly disagree on the right). No total score, each question individual and a tick box. |
| The influence of participant demographics on achieving the primary outcome. | Through study completion, an average of 9 months | Analysis of factors which may influence achievement of the primary outcome. This includes ethnicity, education level, fetal presentation, parity. Presented as event numbers to calculated odds ratio's. |
| Determining participant adherence to commencing the monitoring episodes | Through study completion, an average of 9 months | Defined as the median time between when the participant commencing the monitoring episode and the time originally agreed to commence the monitoring episode previously jointly agreed between the researchers and participant. |
| The influence of fetal movements on achieving the primary outcome | Through study completion, an average of 9 months | Analysis of fetal movements during a monitoring episode and its influence on the primary outcome. Number of movements in the group achieving primary outcome compared to the group not achieving the primary outcome will be compared using the student T test. |
| 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 | Number of unexpected outcomes requiring attendance to triage out of total number of monitoring episodes, presented as a percentage. |
Countries
United Kingdom
Contacts
Primary ContactJack Hamer, MBChB
Outcome results
None listed