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

Completed

• Conditions: Menstrual Problem; Covid19; Vaccine Reaction; Coronavirus; Endometrium

• Registration Number: NCT04854408
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2021-03-18
• Status Verified: 2021-04
• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-04-17
• Study First Posted: 2021-04-22
• Primary Completion: 2021-05-07
• Study Completion: 2021-05-09
• Last Update Submitted: 2021-05-09
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pinar Yalcin Bahat; 🇹🇷 Istanbul, İ̇stanbul, Turkey