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

COVID Clinical Trial

Official title:

Evaluation of Vaginal Fluid for Covid-19 Positivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04437940
• Other study ID #: Acibadem Maslak Ob&Gyn
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 30, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Sars-CoV2

Intervention

Diagnostic Test:
• Vaginal fluid Covid-19 PCR test
Vaginal fluid samples are tested for Covid-19

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal fluid Covid-19 PCR test result	Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive	1 month
Secondary	becoming negative from positive	The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test	2 month