Fetal movement Pregnancy and Childbirth Fetal movement
Conditions
Interventions
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 th
Sponsors
Kymira
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed