uChek Pilot Study for Urinalysis in the Antenatal Care Setting

NCT ID: NCT02256995

Last Updated: 2014-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

375 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Preeclampsia Eclampsia Pregnancy Proteinuria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

uChek

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck for Mothers

OTHER

Sponsor Role collaborator

HOPE Foundation for Women and Children of Bangladesh

UNKNOWN

Sponsor Role collaborator

Maternova Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janardana Sharma, MD

Role: STUDY_DIRECTOR

Hope Bangladesh

Locations

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Hope Hospital for Women and Children

Cox’s Bāzār, , Bangladesh

Site Status

Countries

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Bangladesh

Central Contacts

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Meg E Wirth

Role: CONTACT

4012286294

Allyson E Cote

Role: CONTACT

Other Identifiers

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MATBANG2014

Identifier Type: -

Identifier Source: org_study_id

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