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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381197
• Other study ID #: 4004-B
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2015
• Last updated: March 22, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Gynuity Health Projects
• Contact: Hillary Bracken, PhD
• Phone: 434-249-0286
• Email: hbracken[@]gynuity.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Pregnant

• Willing to give urine samples at prenatal visits

• Eligible to consent to research

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

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

Locations

Country	Name	City	State
Bangladesh	Matlab	Chandpur
Mexico	Hospital Materno-Infantil Inguarán	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Nationwide Children's Hospital

Countries where clinical trial is conducted

Bangladesh,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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