uChek Pilot Study for Urinalysis in the Antenatal Care Setting (uChekBangla)

Maternova Research

Status: Unknown

Conditions: Preeclampsia; Proteinuria; Eclampsia; Pregnancy

Treatments: Device: uChek

Study type: Observational

Funder types: Other

Identifiers

NCT02256995

MATBANG2014

Details and patient eligibility

About

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.

Enrollment: 375 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

375 participants in 1 patient group

Pregnant Women (>22 weeks gestation)

Description:

Biomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application)

Treatment:

Device: uChek