跳至主要内容
临床试验/NCT04854408
NCT04854408已完成不适用

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

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Yalcin bahat

Principal Investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

Loading locations...

相似试验