uChek Pilot Study for Urinalysis in the Antenatal Care Setting

• Conditions: Preeclampsia; Pregnancy; Proteinuria; Eclampsia
• Interventions: Device: uChek

• Registration Number: NCT02256995
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-18
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Study First Posted: 2014-10-06
• Last Update Posted: 2014-10-06
• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 375

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women (>22 weeks gestation)	uChek	Biomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hope Hospital for Women and Children; 🇧🇩 Cox's Bazar, Bangladesh