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

NCT ID: NCT02381197

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Congo Red Dot test

Intervention Type DEVICE

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

Interventions

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Congo Red Dot test

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Buhimschi, Dr

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Beverly Winikoff, Dr

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Matlab

Chāndpur, , Bangladesh

Site Status NOT_YET_RECRUITING

Hospital Materno-Infantil Inguarán

Mexico City, , Mexico

Site Status RECRUITING

Countries

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Bangladesh Mexico

Central Contacts

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Hillary Bracken, PhD

Role: CONTACT

434-249-0286

Meighan Tarnagada, MPH

Role: CONTACT

404-433-7731

Facility Contacts

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Jesmin Pervin, Dr

Role: primary

Anadil Alam, Dr

Role: backup

Carmen C Sotelo, Dr

Role: primary

Other Identifiers

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4004-B

Identifier Type: -

Identifier Source: org_study_id

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