Pregnancy Pregnancy and Childbirth
Conditions
Interventions
Continuous measurement of lactate levels using a microneedle biosensor compared to blood lactate levels to prove the concept for using the device during pregnancy.
The researchers will place the patc
Sponsors
University of Liverpool
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 23/04/2025: Study 1: 1. Consenting pregnant adults =18 years old 2. Healthy with no previously diagnosed medical condition from a medical practitioner 3. Report no pregnancy complications 4. Can be taking prophylactic drugs in pregnancy for example aspirin for low PAPP-A and folic acid and other pregnancy vitamins 5. Report they are able to exercise gently for 30 minutes and do similar exercise routinely 6. Normal fetal movements on the day of participation Study 2: 1. Consenting adults = 18 years old 2. Healthy with no previously diagnosed medical condition from a medical practitioner 3. Report they are able to exercise for 60 minutes, and do similar exercise routinely Previous participant inclusion criteria: 1. Consenting pregnant adults =18 years old 2. Healthy with no previously diagnosed medical condition from a medical practitioner 3. Report no pregnancy complications 4. Can be taking prophylactic drugs in pregnancy for example aspirin for low PAPP-A and folic acid and other pregnancy vitamins 5. Report they are able to exercise gently for 30 minutes and do similar exercise routinely 6. Normal fetal movements on the day of participation
Exclusion criteria
Exclusion criteria: 1. Active inflammatory skin condition such as eczema or dermatitis 2. Active soft tissue infection or infection at any site 3. Known hypersensitivity to any microneedle component/cannula dressing or plasters 4. Presence of any implantable electronic devices such as a pacemaker or stimulators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 23/04/2025: 1. Continuous lactate measurement using the LIP sensor throughout the duration of the study 2. Venous lactate samples measured using a colourimetric assay at baseline, throughout the duration of the exercise and in the post-exercise rest period Previous primary outcome measures: 1. Continuous lactate measurement using the LIP sensor throughout the 3-hour duration of the study 2. Venous lactate samples measured using a colourimetric assay at baseline, throughout the duration of the exercise and in the post-exercise rest period | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/05/2025: 1. Feedback on the experience of wearing the device, measured using a questionnaire immediately after the device is removed 2. Whether the device performs similarly on different parts of the body by comparing the lactate curves throughout the experiment 3. Whether the device can be stored for weeks/months by examining the lactate curves that are produced at several weeks/months after the device is produced Previous secondary outcome measures: Feedback on the experience of wearing the device, measured using a questionnaire immediately after the device is removed | — |
Countries
England, United Kingdom
Contacts
Public ContactTracey Ricketts
Outcome results
None listed