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

NCT04854408 | Completed

• 1 other identifier: Coronavacendometrium
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vaccine Reaction; Coronavirus; Menstrual Problem; Endometrium

Outcome Measures

Primary Outcomes (1)

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

  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.

  40 days

Interventions

healthcare workers with the coronavac vaccine OTHER

Health workers who are vaccinated will fill in the 20-question survey electronically.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

It includes female healthcare workers between the ages of 8 and 45. For participation, 1 or 2 doses of vaccine should be administered and at least one menstrual period after the match.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Pinar Yalcin Bahat

Istanbul, İ̇stanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Menstruation Disturbances

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 22, 2021
• Study Start: March 18, 2021
• Primary Completion: May 7, 2021
• Study Completion: May 9, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-04

Locations

TU (1)