uChek Pilot Study for Urinalysis in the Antenatal Care Setting

Pregnancy Clinical Trial

— uChekBangla  

Official title:

A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02256995
• Other study ID #: MATBANG2014
• Status: Unknown status
• Phase: N/A
• First received: September 18, 2014
• Last updated: October 1, 2014
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2014
• Source: Maternova Research
• Contact: Meg E Wirth
• Phone: 4012286294
• Email: mwirth[@]maternova.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 375
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Preeclampsia
• Pregnancy
• Proteinuria

Intervention

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.

Locations

Country	Name	City	State
Bangladesh	Hope Hospital for Women and Children	Cox's Bazar

Sponsors (3)

Lead Sponsor	Collaborator
Maternova Research	HOPE Foundation for Women and Children of Bangladesh, Merck for Mothers

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 months
Primary	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
Secondary	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: % 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	6 months