NCT02611011

Brief Summary

To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2.3 years until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

November 18, 2015

Last Update Submit

December 31, 2018

Conditions

Preeclampsia

Keywords

Congo Red Dot Test

Outcome Measures

Primary Outcomes (1)

  • CRD Test Comprehension

    proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test

    within 5 minutes of reading test instructions

Secondary Outcomes (1)

  • CRD Test Usability

    within 5 minutes of performing test

Study Arms (1)

Women

Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions

Device: Congo Red Test (GV-005)

Interventions

Congo Red Test (GV-005)DEVICE

The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Women

Eligibility Criteria

Age10 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women attending Centre de Salud Beatriz Velasco de Aleman for health services

You may qualify if:

  • Eligible to consent for research
  • Able to read Spanish well enough to read the test instructions
  • Able to give informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Slaud Beatriz Velasco de Aleman

Mexico City, Mexico

Location

Biospecimen

Retention: NONE RETAINED

urine samples collected

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Beverly Winikoff, Dr

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

December 30, 2018

Last Updated

January 3, 2019

Record last verified: 2018-12

Locations

ME(1)