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

• Sponsor: Acibadem University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04437940
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Vaginal Fluid for Covid-19 Positivity
• Actual Study Start Date: Jun 15, 2020
• Actual Primary Completion Date: Jul 10, 2020
• Actual Study Completion Date: Nov 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Vaginal fluid Covid-19 PCR test result [1 month]

   Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive

Secondary Outcome Measures

1. becoming negative from positive [2 month]

   The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Maslak Hospital	Istanbul		Turkey	34457

Sponsors and Collaborators

• Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ozguc Takmaz, MD,Assistant Professor, Acibadem University
• ClinicalTrials.gov Identifier: NCT04437940
• Other Study ID Numbers: Acibadem Maslak Ob&Gyn
• First Posted: Jun 18, 2020
• Last Update Posted: Jan 12, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Jan 12, 2021