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

Evaluation of Vaginal Fluid for Covid-19 Positivity

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.

Study Overview

• Status: Completed
• Conditions: COVID; Sars-CoV2
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34457
    • Acibadem Maslak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Acibadem University

Publications and helpful links

General Publications

• 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.
• Qiu L, Liu X, Xiao M, Xie J, Cao W, Liu Z, Morse A, Xie Y, Li T, Zhu L. SARS-CoV-2 Is Not Detectable in the Vaginal Fluid of Women With Severe COVID-19 Infection. Clin Infect Dis. 2020 Jul 28;71(15):813-817. doi: 10.1093/cid/ciaa375.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): July 10, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Acibadem Maslak Ob&Gyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data of the patients will be shared without personel informations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No