Wearable device to Observe Movements of your Baby (WOMB) study
| ISRCTN | ISRCTN88921195 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88921195 |
| EudraCT/CTIS number | 2021-002341-15 |
| IRAS number | 288119 |
| Secondary identifying numbers | WOMB01, IRAS 288119 |
- Submission date
- 28/04/2021
- Registration date
- 27/07/2021
- Last edited
- 12/09/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Fetal movements are reassuring for fetal health. It can be difficult for some women to appreciate fetal movements and this can lead to unnecessary medical intervention. We propose to test a thin, flexible textile-like sensor (which is conformable, breathable, and washable) embedded within a wearable garment, KYMIRA will create a solution that is easier and more comfortable for longer-term monitoring. Moreover, the wearable will be fully washable, enabling better hygiene and potentially allowing 24-hour monitoring.
We aim to correlate objectively measured fetal movements with those detected by the device via real-time imaging of the moving fetus using ultrasound. The study intervention will involve four ultrasound scans lasting 20 min during which fetal movements will be recorded by the scan operator. The fabric device will also be worn on the mother’s abdomen and will also be recording movement. The mother will also have a button to press when she feels movements. The four scans will happen at 2-week intervals from 32 weeks of pregnancy.
Other studies have looked into various devices. Often these are bulky, non-washable and require hospital visits. Some use methods, such as picking up the acoustics of fetal movement. Our device works by using a piezoelectric fabric which essentially generates a tiny voltage when the material is bent or stretched.
Who can participate?
Women aged 18-40 who are pregnant with one baby and have a body mass index (BMI) between 18-30.
What does the study involve?
Participants will be asked to attend 4 extra ultrasound scans in the later part of their pregnancy. A fabric device will be worn which is designed to pick up movements of the fetus. Both the mother, the device, and the scan operator will be assessing fetal movements.
What are the possible risks and benefits?
Taking part in the trial is not going to be directly beneficial to participants, although they will get to see their baby on scan a few extra times. The disadvantage of taking part in the trial is that participants will be asked to come into the hospital for four extra scans between 32 and 38 weeks of pregnancy. This will take time out of their day.
Where is the study run from?
Cambridge University Hospitals NHS Foundation Trust (UK) and University Hospitals of Leicester (UK)
When is the study starting and how long is it expected to run for?
From June 2021 to December 2025
Who is funding the study?
Kymira (UK) through an Innovate UK grant
Who is the main contact?
Dr Suzi Dunkerton
Suzanna.dunkerton@uhl-tr.nhs.uk
Contact information
Scientific
Consultant in Fetomaternal medicine
Obstetric secretary’s
Kensington building
Leicester Royal Infirmary
Infirmary square
Leicester
LE15WW
United Kingdom
 ORCID ID |
0000-0001-9258-0804 |
|---|---|
| Phone | +44 (0)1162587770 |
| Suzanna.dunkerton@uhl-tr.nhs.uk |
Study information
| Study design | Multicentre single-arm non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN88921195_PIS_v1_12May2016.pdf |
| Scientific title | Wearable device to Observe Movements of your Baby (WOMB) study |
| Study acronym | WOMB |
| Study objectives | To determine the effectiveness of the wearable device in detecting fetal movements, as identified by the operator scanning, compared with those detected by the pregnant women. |
| Ethics approval(s) |
Approved 18/04/2023, Health and Social Care Research Ethics Committee A (HSC REC A) (ORECNI, Lissure Industrial Estate West, 5 Rathdown Walk, Lisburn, BT282RF, United Kingdom; +44 (0)28 9536 1400; RECA@hscni.net), ref: 21/NI/0115 |
| Health condition(s) or problem(s) studied | Fetal movement |
| Intervention | Pregnant women in their third trimester with a singleton pregnancy will test a device designed to pick up fetal movements. The WOMB device will be worn for 20 min by the pregnant participant in the third trimester during ultrasound scans at weeks 32, 34, 36, and 38 of pregnancy. A scan operator and the mother will also be determining when the fetus is moving. The results will then be correlated with what the wearable device has picked up. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fabric device |
| Primary outcome measure | Effectiveness of the wearable device in detecting fetal movements, as identified by the operator scanning, compared with those detected by the pregnant women measured using data from the wearable device, ultrasound scan, and maternal report during the 20 min scan at weeks 32, 34, 36, and 38 of pregnancy |
| Secondary outcome measures | 1. Proportion of movements detected by the device and by the pregnant women that are true-positives, that is those that are also identified by the scan operator (i.e., their positive-predictive value rates) measured using data from the wearable device, ultrasound scan, and maternal report during the 20 min scan at weeks 32, 34, 36, and 38 of pregnancy 2. Acceptability of wearing the device as self-reported by the women in a bespoke end of study questionnaire |
| Overall study start date | 01/01/2020 |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 54 |
| Key inclusion criteria | 1. Willing and able to give informed consent for participation in the study 2. Aged between 18 and 40 years 3. ≤32 weeks gestation 4. Body mass index (BMI) between 18 and 30 at booking 5. Able (in the Investigator's opinion) and willing to comply with all study requirements 6. Willing to allow their General Practitioner and Obstetric Consultant, to be notified of participation in the study 7. Singleton pregnancy |
| Key exclusion criteria | 1. Any concerns have been raised at previous scans, although if the scan has been reviewed by fetal medicine and deemed there are no concerns then the patient can be included 2. Delivery planned prior to 39 weeks at recruitment. 3. Multiple pregnancy |
| Date of first enrolment | 01/10/2024 |
| Date of final enrolment | 01/10/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Leicester
LE15WW
United Kingdom
Sponsor information
Industry
Unit 59-61 Milford Road Trading Est.
Milford Road
Reading
RG1 8LG
United Kingdom
| Phone | +44 (0)7722444918 |
|---|---|
| phil@kymira.co.uk | |
| Website | https://kymira.co.uk/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in high impact peer reviewed journals. |
| IPD sharing plan | Data collected from the device that is worn by participants will be kept by Kymira and are not expected to be made available. The analysed data collected during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 12/05/2016 | 27/07/2021 | No | Yes |
| Protocol file | version 2 | 12/04/2021 | 27/07/2021 | No | No |
Additional files
Editorial Notes
12/09/2024: The following changes have been made:
1. The recruitment start date was changed from 01/01/2024 to 01/10/2024.
2. The recruitment end date was changed from 01/09/2024 to 01/10/2025.
3. The overall study end date was changed from 31/03/2025 to 01/12/2025.
4. The intention to publish date was changed from 01/01/2026 to 01/03/2026.
15/09/2023: The following changes have been made:
1. The recruitment end date was changed from 01/01/2025 to 01/09/2024.
2. The overall study end date was changed from 01/10/2025 to 31/03/2025.
12/09/2023: The following changes have been made:
1. The recruitment start date was changed from 01/06/2021 to 01/01/2024.
2. The recruitment end date was changed from 21/12/2021 to 01/01/2025.
3. The overall study end date was changed from 01/01/2023 to 01/10/2025.
4. The intention to publish date was changed from 01/01/2023 to 01/01/2026.
08/09/2023: The following changes were made:
1. The scientific contact was updated.
2. Ethics approval was added.
12/05/2021: Trial’s existence confirmed by KYMIRA Ltd.
