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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437940
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Ozguc Takmaz, Acibadem University

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.

Condition or disease Intervention/treatment
COVID Sars-CoV2 Diagnostic Test: Vaginal fluid Covid-19 PCR test

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Vaginal Fluid for Covid-19 Positivity
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : July 30, 2020

Group/Cohort Intervention/treatment
Covid-19 positive women
Women with nasofarangeal Covid-19 PCR test is positive
Diagnostic Test: Vaginal fluid Covid-19 PCR test
Vaginal fluid samples are tested for Covid-19




Primary Outcome Measures :
  1. Vaginal fluid Covid-19 PCR test result [ Time Frame: 1 month ]
    Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive


Secondary Outcome Measures :
  1. becoming negative from positive [ Time Frame: 2 month ]
    The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test


Biospecimen Retention:   Samples Without DNA
Vaginal fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who are older than 18 years old Women who had sexual intercourse before
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04437940


Contacts
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Contact: Ozguc Takmaz, MD,Assist.Prof +905554006591 ozguctakmaz@hotmail.com

Locations
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Turkey
Acibadem Maslak Hospital Recruiting
Istanbul, Turkey, 34457
Contact: Ozguc Takmaz, Assist. Prof.    05554006591    ozguctakmaz@hotmail.com   
Contact: Eren Kaya, MD    +905359799914    erenkaya@acibadem.com   
Sub-Investigator: Burak Celik         
Sponsors and Collaborators
Acibadem University
Publications of Results:
Other Publications:
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Responsible Party: Ozguc Takmaz, MD,Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier: NCT04437940    
Other Study ID Numbers: Acibadem Maslak Ob&Gyn
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data of the patients will be shared without personel informations

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No