Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers’ Menstrual Patterns

Overview

Coronavac, one of the vaccines developed within the scope of combating the COVID-19 pandemic that has surrounded the world for a year, started to be applied in the first healthcare workers in our country. In this important step taken to end the pandemic, information on vaccines is still limited. Most vaccines, including the Coronavac vaccine, are applied with approval for emergency use before phase 3 studies are fully completed. While investigating the effect of the vaccine on the virus, possible side effects should also be considered. In this context, it is not known whether the vaccine has an effect on the menstrual cycle, especially of women of reproductive age. Our primary aim in our study is to evaluate the effect of the vaccine on the menstrual cycle and if the vaccine has any effect on the menstrual cycle, what kind of changes this effect causes.

Full Title of Study: “the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers’ Menstrual Patterns”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 7, 2021

Detailed Description

The survey contains 20 questions aimed at obtaining information about the menstrual cycles of health workers before and after vaccination. Demographic data of the participants are also taken.

Interventions

  • Other: healthcare workers with the coronavac vaccine
    • Health workers who are vaccinated will fill in the 20-question survey electronically.

Clinical Trial Outcome Measures

Primary Measures

  • Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle
    • Time Frame: 40 days
    • The change in the menstrual cycle of vaccinated healthcare workers after the first or the second dose is questioned with 20 questions. The content of the question consists of yes and no questions explaining the general epidemiological data of the patients and the amount of menstruation. These questions question the amount and change of menstruation before and after the vaccine.

Participating in This Clinical Trial

Inclusion Criteria

  • be positive for covid-19 (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) – Having 1 or 2 doses of vaccine – have menstruation – Being a female health worker – not using drugs that can affect menstruation Exclusion Criteria:

  • be negative for covid-19(severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) – have no menstruation – Being a male health worker

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kanuni Sultan Suleyman Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pınar Yalcin bahat, Principal Investigator – Kanuni Sultan Suleyman Training and Research Hospital

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