uChek Pilot Study for Urinalysis in the Antenatal Care Setting (uChekBangla)
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|ClinicalTrials.gov Identifier: NCT02256995|
Recruitment Status : Unknown
Verified October 2014 by Maternova Research.
Recruitment status was: Not yet recruiting
First Posted : October 6, 2014
Last Update Posted : October 6, 2014
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|Condition or disease||Intervention/treatment|
|Preeclampsia Eclampsia Pregnancy Proteinuria||Device: uChek|
|Study Type :||Observational|
|Estimated Enrollment :||375 participants|
|Official Title:||A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||June 2015|
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)
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.
- Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting [ Time Frame: 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.
- Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC [ Time Frame: 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
- Feasibility of using uChek for expanded urinalysis panel in ANC [ Time Frame: 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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.
- Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256995
|Contact: Meg E Wirthfirstname.lastname@example.org|
|Contact: Allyson E Coteemail@example.com|
|Hope Hospital for Women and Children|
|Cox's Bazar, Bangladesh, 4700|
|Study Director:||Janardana Sharma, MD||Hope Bangladesh|
|Responsible Party:||Maternova Research|
|Other Study ID Numbers:||
|First Posted:||October 6, 2014 Key Record Dates|
|Last Update Posted:||October 6, 2014|
|Last Verified:||October 2014|