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| Name | Class |
|---|---|
| Merck for Mothers | OTHER |
| HOPE Foundation for Women and Children of Bangladesh | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women (>22 weeks gestation) | Biomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uChek | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of using uChek for expanded urinalysis panel in ANC | 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. |
Inclusion Criteria:
Exclusion Criteria:
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There are two unique subject populations in this study. One group consists of pregnant women whose urine will be analyzed- hereafter referred to as the Patient Participants. The second group is a cohort of medical professionals who will answer a questionnaire about the usability of the device, relating to the second objective, hereafter referred to as the Medical Staff Participants. The following parameters have been answered in reference to the Patient Participants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meg E Wirth | Contact | 4012286294 | mwirth@maternova.net | |
| Allyson E Cote | Contact | allysonecote@maternova.net |
| Name | Affiliation | Role |
|---|---|---|
| Janardana Sharma, MD | Hope Bangladesh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Hospital for Women and Children | Cox’s Bāzār | 4700 | Bangladesh |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 26, 2016 | |
| Reset | Mar 28, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 26, 2016 | Mar 28, 2016 |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D004461 | Eclampsia |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 6 months |
| 6 months |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |