uChek Pilot Study for Urinalysis in the Antenatal Care Setting

NCT02256995 | Unknown DMC

• 1 other identifier: MATBANG2014
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Eclampsia; Pregnancy; Proteinuria

Keywords

Pregnancy; Preeclampsia; Eclampsia; Proteinuria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC

  6 months

Other Outcomes (1)

• Feasibility of using uChek for expanded urinalysis panel in ANC

  6 months

Study Arms (1)

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

Interventions

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.

Pregnant Women (>22 weeks gestation)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.

You may not qualify if:

• Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.

Sponsors & Collaborators

• Maternova Research: lead
• Merck for Mothers: collaborator
• HOPE Foundation for Women and Children of Bangladesh: collaborator

Study Sites (1)

Hope Hospital for Women and Children

Cox’s Bāzār, 4700, Bangladesh

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; Proteinuria

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janardana Sharma, MD

  Hope Bangladesh

  STUDY DIRECTOR

Central Study Contacts

Meg E Wirth

CONTACT

4012286294; mwirth@maternova.net

Allyson E Cote

CONTACT

allysonecote@maternova.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: October 6, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

BA (1)