NCT02381197

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
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DEVICE	Congo Red Dot test	The Congo Red Dot test is a simple dye test that detects unfolded or misfolded proteins

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-03-06
• Last updated: 2017-03-23

Locations

2 sites across 2 countries: Bangladesh, Mexico