Pregnancy Clinical Trial
— uChekBanglaOfficial title:
A Prospective Observational Pilot Study to Test the Feasibility of Smartphone Enabled uChek Urinalysis Device in Bangladesh
Verified date | October 2014 |
Source | Maternova Research |
Contact | Meg E Wirth |
Phone | 4012286294 |
mwirth[@]maternova.net | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Unknown status |
Enrollment | 375 |
Est. completion date | June 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Hope Hospital for Women and Children | Cox's Bazar |
Lead Sponsor | Collaborator |
---|---|
Maternova Research | HOPE Foundation for Women and Children of Bangladesh, Merck for Mothers |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Feasibility of using uChek for expanded urinalysis panel in ANC | 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. | 6 months | |
Primary | 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 | 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 |
6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Completed |
NCT02566005 -
A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor
|
N/A |