Longitudinal Study: Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico
Diagnosis and Prediction of Preeclampsia: A Longitudinal Study of the Clinical Utility of Congo Red Dot Test in Bangladesh and Mexico
1 other identifier
observational
2,000
2 countries
2
Brief Summary
A population-based prospective cohort design will evaluate the progression of urine congophilia in pregnancy using the Congo Red Dot test by following patients longitudinally across gestation in Bangladesh and Mexico City.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 23, 2017
March 1, 2017
5 months
February 25, 2015
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of urine congophilia
Use the Congo Red Dot test to identify urine congophilia among participants and evaluate progression of urine congophilia in pregnancy
within 15 days of urine sample collection
Study Arms (1)
pregnant women
Women presenting for prenatal care will provide urine samples at each antenatal care visit. The sample will be used to perform a Congo Red Dot test.
Interventions
The Congo Red Dot test is a simple dye test that detects unfolded or misfolded proteins
Eligibility Criteria
In Bangladesh, pregnant women will be identified during monthly home visits of Community Health Workers (CHW) affiliated with Matlab in Chandpur and asked to participate. In Mexico, women will be identified at routine antenatal appointments at Hospital Materno-Infantil Inguarán.
You may qualify if:
- Pregnant
- Willing to give urine samples at prenatal visits
- Eligible to consent to research
You may not qualify if:
- \- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynuity Health Projectslead
- Nationwide Children's Hospitalcollaborator
Study Sites (2)
Matlab
Chāndpur, Bangladesh
Hospital Materno-Infantil Inguarán
Mexico City, Mexico
Biospecimen
urine samples collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irina Buhimschi, Dr
Nationwide Children's Hospital
- PRINCIPAL INVESTIGATOR
Beverly Winikoff, Dr
Gynuity Health Projects
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2015
First Posted
March 6, 2015
Study Start
January 1, 2017
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made available to the public.