PreeclampsiauChekBanglaNCT02256995
uChek Pilot Study for Urinalysis in the Antenatal Care Setting
An observational study of Preeclampsia and Eclampsia, run by Maternova Research at 1 site in Bangladesh.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Eclampsia, Pregnancy
- What is being tested?
- uChek
- Type of treatment
- Medical device
- How many people
- 375 participants
- Where
- 1 siteBangladesh
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Allyson E Cote contact
About this study
Official title: A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh
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
- Being tested
- uChek
- Keywords
- Pregnancy, Preeclampsia, Eclampsia, Proteinuria
- Medical subject headings
- Pre-Eclampsia, Eclampsia, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uChekDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: uChek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
- 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.
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternova Research
- Sponsor type
- University, hospital or other
- Collaborators
- Merck for Mothers, HOPE Foundation for Women and Children of Bangladesh
- Responsible party
- Sponsor
- Investigators
- Janardana Sharma, MD, Study director, Hope Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256995
- Sponsor's protocol ID
- MATBANG2014
- Acronym
- uChekBangla
- Status last verified
- Oct 2014
- First submitted
- 18 Sep 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh
- ClinicalTrials.gov ID
- NCT02256995
- Acronym / sponsor ID
- uChekBangla / MATBANG2014
- Conditions
- Preeclampsia, Eclampsia, Pregnancy, Proteinuria
- Keywords
- Pregnancy, Preeclampsia, Eclampsia, Proteinuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Maternova ResearchUniversity, hospital or other
- Collaborators
- Merck for Mothers, HOPE Foundation for Women and Children of Bangladesh
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women (>22 weeks gestation) | – | Device: uChekBiomarkers tracked over 3 antenatal care visits via standard of care (dipstick, manually/visually assessed) and via uChek (automated assessment via computer application) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.
Key exclusion criteria (1 listed)
- Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uChekThe 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. | Device | Pregnant Women (>22 weeks gestation) |
Primary outcome
Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting
Time frame: 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.
1 secondary outcome
Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allyson E Cote contact
Janardana Sharma, MD study director
Hope Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia and Eclampsia, run by Maternova Research at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meg E Wirth (4012286294, mwirth@maternova.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014; AzTrials last refreshed its copy on 2 Nov 2026.