Eclampsia, Preeclampsia, Pregnancy, Proteinuria
Conditions
Keywords
Pregnancy, Preeclampsia, Eclampsia, Proteinuria
Brief summary
A prospective observational study to test the feasibility of smartphone enabled uChek urinalysis device to detect biomarkers (protein, microalbumin and protein:creatine ratio) in urine, indicative of preeclampsia/eclampsia at over 22 weeks of gestation and assess attitudes of clinicians towards uChek as a new technology for urinalysis.
Interventions
DEVICEuChek
The uChek TM urine analyzer is a semi-automated urinalysis system, installed as an application on a smartphone. It makes use of a smartphone's camera to automatically read urine dipsticks.
Sponsors
Merck for Mothers
HOPE Foundation for Women and Children of Bangladesh
Maternova Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.
Exclusion criteria
* Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting | 6 months | 1\. Test the feasibility of using the uChek urinalysis device to detect biomarkers of preeclampsia/eclampsia at over 22 weeks of gestation as compared to using the sites' current urinalysis method. A correlation analysis of the rate of detection of protein in urine between the uChek and the standard visual dipstick test using the quantitative results from the visual dipstick test and uChek results collected at each of three ANC visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC | 6 months | Assess impressions, preferences and attitudes of the clinicians towards the uChek as a tool for urinalysis in antenatal care. A quantitative analysis of questionnaire responses about the usability of the device, including but not limited to: * % agree or strongly agree that the uChek is an accurate urinalysis device * % reporting that they agree or strongly agree that uChek is easier to use than current method of urinalysis * % reporting that they agree or strongly agree that uChek is a suitable technology for a low resource setting |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of using uChek for expanded urinalysis panel in ANC | 6 months | To assess the feasibility of tracking additional biomarkers of conditions affecting pregnant women using urinalysis via the uChek device(glucose for gestational diabetes, nitrites for urinary tract infection, presence of blood, microalbumin for risk of preterm birth, etc.). A quantitative analysis of results of tests for additional biomarkers, detected with the uChek, of conditions affecting pregnant women. |
Countries
Bangladesh
Contacts
Primary ContactMeg E Wirth
Backup ContactAllyson E Cote
Outcome results
None listed