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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02381197
Enrollment
2000
Registered
2015-03-06
Start date
2017-01-31
Completion date
2017-06-30
Last updated
2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Congo Red Dot Test

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.

Detailed description

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. A total of 2000 women presenting for prenatal care will be enrolled (1000 at each site). 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. If the woman agrees to participate, investigators will ask her to consent to donation of urine for testing (Congo Red Dot test and Proteinuria dipstick test) at the time of enrollment, four times during her pregnancy (first trimester 6-12 weeks; second trimester 13-28 weeks; third trimester 29-36 weeks; term 37-41 weeks) and possibly three times postpartum (24 hours after delivery and daily until discharge). As a result, the enrolled patients will be followed longitudinally throughout pregnancy until delivery of the baby either at term for an uncomplicated gestation or preterm/term for preeclampsia. The group of women who develop preeclampsia will represent the study group. At the end of the study, the results will be analyzed to identify how many weeks in advance the women who developed preeclampsia displayed congophilia.

Interventions

The Congo Red Dot test is a simple dye test that detects unfolded or misfolded proteins

Sponsors

Gynuity Health Projects
Lead SponsorOTHER
Nationwide Children's Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant * Willing to give urine samples at prenatal visits * Eligible to consent to research

Exclusion criteria

\- None

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of urine congophiliawithin 15 days of urine sample collectionUse the Congo Red Dot test to identify urine congophilia among participants and evaluate progression of urine congophilia in pregnancy

Countries

Bangladesh, Mexico

Contacts

Primary ContactHillary Bracken, PhD
hbracken@gynuity.org434-249-0286
Backup ContactMeighan Tarnagada, MPH
mtarnagada@gynuity.org404-433-7731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026