Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-21 @ 9:07 PM
Study NCT ID:
NCT02256995
Status:
UNKNOWN
Last Update Posted:
2014-10-06
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
uChek Pilot Study for Urinalysis in the Antenatal Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-03-28', 'releaseDate': '2016-02-26'}], 'estimatedResultsFirstSubmitDate': '2016-02-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-01', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility of using uChek for expanded urinalysis panel in ANC', 'timeFrame': '6 months', 'description': 'To assess the feasibility of tracking additional biomarkers of conditions affecting pregnant women using urinalysis via the uChek device(glucose for gestational diabetes, nitrites for urinary tract infection, presence of blood, microalbumin for risk of preterm birth, etc.). A quantitative analysis of results of tests for additional biomarkers, detected with the uChek, of conditions affecting pregnant women.'}], 'primaryOutcomes': [{'measure': 'Feasibility of using uChek for standard urinalysis in an antenatal care (ANC) setting', 'timeFrame': '6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Impressions and attitudes of healthcare workers re: uChek for urinalysis in ANC', 'timeFrame': '6 months', 'description': '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:\n\n* % agree or strongly agree that the uChek is an accurate urinalysis device\n* % reporting that they agree or strongly agree that uChek is easier to use than current method of urinalysis\n* % reporting that they agree or strongly agree that uChek is a suitable technology for a low resource setting'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy', 'Preeclampsia', 'Eclampsia', 'Proteinuria'], 'conditions': ['Preeclampsia', 'Eclampsia', 'Pregnancy', 'Proteinuria']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant with a gestational age of over 22 weeks and ability to follow pregnancy till delivery.\n\nExclusion Criteria:\n\n* Study participant is unwilling to take part in study or participants with pathological conditions that restrict them from providing a urine sample without catheterization.'}, 'identificationModule': {'nctId': 'NCT02256995', 'acronym': 'uChekBangla', 'briefTitle': 'uChek Pilot Study for Urinalysis in the Antenatal Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'Maternova Research'}, 'officialTitle': 'A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh', 'orgStudyIdInfo': {'id': 'MATBANG2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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)', 'interventionNames': ['Device: uChek']}], 'interventions': [{'name': 'uChek', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Pregnant Women (>22 weeks gestation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4700', 'city': 'Cox’s Bāzār', 'country': 'Bangladesh', 'facility': 'Hope Hospital for Women and Children', 'geoPoint': {'lat': 21.43973, 'lon': 92.00955}}], 'centralContacts': [{'name': 'Meg E Wirth', 'role': 'CONTACT', 'email': 'mwirth@maternova.net', 'phone': '4012286294'}, {'name': 'Allyson E Cote', 'role': 'CONTACT', 'email': 'allysonecote@maternova.net'}], 'overallOfficials': [{'name': 'Janardana Sharma, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hope Bangladesh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maternova Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck for Mothers', 'class': 'OTHER'}, {'name': 'HOPE Foundation for Women and Children of Bangladesh', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-02-26', 'type': 'RELEASE'}, {'date': '2016-03-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maternova Research'}}}}