Longitudinal Study: Diagnosis and Prediction of Pre-Eclam... | NCT02381197

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

NCT02381197

Sponsor

Gynuity Health Projects

Status

Unknown status

Last Update Posted

Mar 23, 2017Actual

Enrollment

2,000Estimated

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

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jun 2017Estimated

Completion Date

Jun 2017Estimated

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

Mar 22, 2017

Last Update Posted Date

Mar 23, 2017Actual

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

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.

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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 dye test that detects unfolded or misfolded proteins	pregnant women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

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 at Hospital Materno-Infantil Inguarán.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hillary Bracken, PhD	Contact	434-249-0286		hbracken@gynuity.org
Meighan Tarnagada, MPH	Contact	404-433-7731		mtarnagada@gynuity.org

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
Matlab	Not yet recruiting	Chāndpur			Bangladesh

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data will not be made available to the public.

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

Browse Leaves

Not provided

Browse Branches

Not provided