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

NCT04437940 | Completed

• 1 other identifier: Acibadem Maslak Ob&Gyn
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• becoming negative from positive

  2 month

Study Arms (1)

Covid-19 positive women

Women with nasofarangeal Covid-19 PCR test is positive

Diagnostic Test: Vaginal fluid Covid-19 PCR test

Interventions

Vaginal fluid Covid-19 PCR test DIAGNOSTIC_TEST

Vaginal fluid samples are tested for Covid-19

Covid-19 positive women

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Women who are older than 18 years old Women who had sexual intercourse before
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• who had medical treatment for Covid-19

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 32376320 BACKGROUND

• 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.

  PMID: 32241022 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal fluid

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Assistant Professor

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 18, 2020
• Study Start: June 15, 2020
• Primary Completion: July 10, 2020
• Study Completion: November 30, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

TU (1)