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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
Sponsor:
Collaborators:
Merck for Mothers
HOPE Foundation for Women and Children of Bangladesh
Information provided by (Responsible Party):
Maternova Research

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.

Condition or disease Intervention/treatment
Preeclampsia Eclampsia Pregnancy Proteinuria Device: uChek

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Study Type : Observational
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy Urinalysis

Group/Cohort Intervention/treatment
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)
Device: uChek
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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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
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Meg E Wirth 4012286294 mwirth@maternova.net
Contact: Allyson E Cote allysonecote@maternova.net

Locations
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Bangladesh
Hope Hospital for Women and Children
Cox's Bazar, Bangladesh, 4700
Sponsors and Collaborators
Maternova Research
Merck for Mothers
HOPE Foundation for Women and Children of Bangladesh
Investigators
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Study Director: Janardana Sharma, MD Hope Bangladesh
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Responsible Party: Maternova Research
ClinicalTrials.gov Identifier: NCT02256995    
Other Study ID Numbers: MATBANG2014
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014
Keywords provided by Maternova Research:
Pregnancy
Preeclampsia
Eclampsia
Proteinuria
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Proteinuria
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urologic Diseases
Urological Manifestations