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Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico

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ClinicalTrials.gov Identifier: NCT02381210
Recruitment Status : Completed
First Posted : March 6, 2015
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
A cross sectional study design will evaluate the diagnostic value of the CRD test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City.

Condition or disease Intervention/treatment
Preeclampsia Device: Congo Red Dot Test

Detailed Description:
A cross sectional study design will evaluate the diagnostic value of the Congo Red Dot test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City. Women attending the hospital with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study. Investigators will enroll about 200 women at each facility. Investigators will target the following women for enrollment: women with clinical diagnosis of preeclampsia (severe, mild or superimposed) (n=100); and clinically healthy women who deliver at term (n=100). The purpose of the research is to determine the clinical utility of congophilia (affinity for the dye Congo Red) in the diagnosis and prediction of preeclampsia. Investigators will determine the diagnostic value of this test by testing the urine sample provided to determine the presence or absence of proteinuria or congophilia.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnosis and Prediction of Preeclampsia: A Case Control Study of the Clinical Utility of Congo Red Dot Test in Bangladesh and Mexico
Study Start Date : July 2016
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CLINICALLY CONFIRMED PREECLAMPSIA
Pregnant women with clinical diagnosis of preeclampsia (severe, mild or superimposed) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.
Device: Congo Red Dot Test
The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.

CLINICALLY HEALTHY
Pregnant women admitted to the hospital for delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.
Device: Congo Red Dot Test
The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.




Primary Outcome Measures :
  1. Prevalence of urine congophilia using Congo Red Dot test [ Time Frame: within 1 month of urine sample collection ]

Biospecimen Retention:   Samples Without DNA
urine samples collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women attending Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study.
Criteria

Inclusion Criteria:

  • Pregnant
  • Willing to provide a urine sample
  • Eligible to consent to research according to local laws and regulations
  • Present with a clinical diagnosis of preeclampsia (severe, mild or superimposed) OR clinically healthy and delivering at term

Exclusion Criteria:

-None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381210


Locations
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Bangladesh
Dhaka Medical College
Dhaka, Bangladesh
Mexico
Hospital Materno-Infantil Inguarán
Mexico City, Mexico
Sponsors and Collaborators
Gynuity Health Projects
Nationwide Children's Hospital
Investigators
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Principal Investigator: Irina Buhimschi, Dr Nationwide Children's Hospital
Principal Investigator: Beverly Winikoff, Dr Gynuity Health Projects

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02381210    
Other Study ID Numbers: 4004-A
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gynuity Health Projects:
Congo Red Dot Test
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications