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

ClinicalTrials.gov ID

NCT02381197

Lead Sponsor

Gynuity Health ProjectsOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

2,000Estimated

Last Update Posted

Mar 23, 2017Actual

Start Date

Jan 2017Actual

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

Official Title

Diagnosis and Prediction of Preeclampsia: A Longitudinal Study of the Clinical Utility of Congo Red Dot Test in Bangladesh and Mexico

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.

• Preeclampsia

• Congo Red Dot test

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Gynuity Health ProjectsOTHER

Collaborators

Nationwide Children's HospitalOTHER

patriciosanhueza@prodigy.net.mx

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

  NCT02381210

  CompletedObservationalUpdated Feb 8, 2019
• The Clinical Utility of the Congo-Red Dot Test for Diagnosis and Early Prediction of Preeclampsia During Pregnancy

  NCT02455544

  CompletedObservationalUpdated Oct 9, 2018
• Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Case-control Study

  NCT02610972

  CompletedObservationalUpdated Sep 20, 2019
• Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey

  NCT02611011

  CompletedObservationalUpdated Jan 3, 2019
• The Prediction of Preeclampsia/Toxemia in Twin Pregnancy

  NCT01255202

  Unknown statusObservationalUpdated Dec 7, 2010
• CercaTest™ Red Urine Test for Predicting Preeclampsia

  NCT07625501

  Active, not recruitingObservationalUpdated Jun 4, 2026