Evaluation of Vaginal Fluid for Covid-19 Positivity in Wo... | NCT04437940

Studies
Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test

NCT04437940

Sponsor

Acibadem University

Status

Completed

Last Update Posted

Jan 12, 2021Actual

Enrollment

38Actual

Phase

Not provided

Conditions

COVID
Sars-CoV2

Interventions

Vaginal fluid Covid-19 PCR test

Countries

Turkey (Türkiye)

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

Jan 2021

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

Jun 15, 2020Actual

Primary Completion Date

Jul 10, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 18, 2020Actual

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

Jan 11, 2021

Last Update Posted Date

Jan 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.

Detailed Description

Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral clearance.

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Covid-19 positive women		Women with nasofarangeal Covid-19 PCR test is positive	Diagnostic Test: Vaginal fluid Covid-19 PCR test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal fluid Covid-19 PCR test	Diagnostic Test	Vaginal fluid samples are tested for Covid-19	Covid-19 positive women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal fluid Covid-19 PCR test result	Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive	1 month

Secondary Outcomes

Measure	Description	Time Frame
becoming negative from positive	The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test	2 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who are positive nasofarengeal Covid-19 PCR test result
Women who are 18 years or older
Women who had sexual intercourse before

Exclusion Criteria:

who had medical treatment for Covid-19

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women who are older than 18 years old Women who had sexual intercourse before

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Women who are older than18 years old, who are considered to be covid-19 clinically and radiologically positive or nasofarengeal Covid-19 PCR test is positive will be included.

Patients previously treated for covid-19 will be excluded from the study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Acibadem Maslak Hospital		Istanbul		34457	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32376320	Background	Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, Jiang J, Liu J, Zhang C, Shan W, Wang S, Rong Y, Chang J, Miao X, Ma X, Wang S. Severe acute respiratory syndrome coronavirus 2 detection in the female lower genital tract. Am J Obstet Gynecol. 2020 Jul;223(1):131-134. doi: 10.1016/j.ajog.2020.04.038. Epub 2020 May 4. No abstract available.
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