Diagnosis and Prediction of Pre-Eclampsia by Using Congo... | NCT02381210

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

NCT02381210

Sponsor

Gynuity Health Projects

Status

Completed

Last Update Posted

Feb 8, 2019Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Preeclampsia

Interventions

Congo Red Dot Test

Countries

Bangladesh
Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

Feb 25, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2019

Last Update Posted Date

Feb 8, 2019Actual

Name	Class
Nationwide Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A cross sectional study design will evaluate the diagnostic value of the CRD test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City.

Detailed Description

A cross sectional study design will evaluate the diagnostic value of the Congo Red Dot test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City. Women attending the hospital with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study. Investigators will enroll about 200 women at each facility. Investigators will target the following women for enrollment: women with clinical diagnosis of preeclampsia (severe, mild or superimposed) (n=100); and clinically healthy women who deliver at term (n=100). The purpose of the research is to determine the clinical utility of congophilia (affinity for the dye Congo Red) in the diagnosis and prediction of preeclampsia. Investigators will determine the diagnostic value of this test by testing the urine sample provided to determine the presence or absence of proteinuria or congophilia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CLINICALLY CONFIRMED PREECLAMPSIA		Pregnant women with clinical diagnosis of preeclampsia (severe, mild or superimposed) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.	Device: Congo Red Dot Test
CLINICALLY HEALTHY		Pregnant women admitted to the hospital for delivery of a healthy normal baby at term (induction of labor or an elective Caesarean Section) will provide a urine sample to determine the presence or absence of proteinuria using the Congo Red Dot test.	Device: Congo Red Dot Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Congo Red Dot Test	Device	The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.	CLINICALLY CONFIRMED PREECLAMPSIA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of urine congophilia using Congo Red Dot test		within 1 month of urine sample collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant
Willing to provide a urine sample
Eligible to consent to research according to local laws and regulations
Present with a clinical diagnosis of preeclampsia (severe, mild or superimposed) OR clinically healthy and delivering at term

Exclusion Criteria:

-None

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Women attending Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irina Buhimschi, Dr	Nationwide Children's Hospital	Principal Investigator
Beverly Winikoff, Dr	Gynuity Health Projects	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dhaka Medical College		Dhaka			Bangladesh
Hospital Materno-Infantil Inguarán

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011225	Pre-Eclampsia

Ancestor Terms

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

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Browse Branches

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