Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine (MECOVAC-1)

Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection among the general population, reducing significantly both morbidity and mortality.

Nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual Irregularities or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual Irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.

Study Overview

• Status: Completed
• Conditions: COVID-19; Menstrual Irregularity; Vaccine; Menopausal Bleeding
• Intervention / Treatment: Biological: Covid-19 vaccine

• Study Type: Observational
• Enrollment (Actual): 369

Contacts and Locations

Study Locations

• Italy
  • Varese, Italy
    • University of Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Description

Inclusion Criteria:

• Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

Exclusion Criteria:

• Women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, GnRH-analogues, aromatase inhibitors, hormonal replacement therapy in menopause;
• Surgical menopause (hysterectomy and/or bilateral oophorectomy);
• Breastfeeding.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women who underwent Covid-19 vaccination; This group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used.	Biological: Covid-19 vaccine; First dose or complete cycle of Comirnaty (Pfizer/BioNTech) vaccine; First dose or complete cycle of Spikevax (Moderna) vaccine; First dose or complete cycle of AstraZeneca/Vaxzevria vaccine; Complete cycle of vaccination using one type of vaccine for the first dose and a different type for the second dose; Janssen (Johnson & Johnson) vaccine (single dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of the menstrual cycle	In women of reproductive age, any frequency shorter than 25 days or longer than 36 days will be defined as abnormal	30 days after the administration of the first and second doses of vaccine
Quantity of the menstrual cycle	In women of reproductive age, any quantity less than 30 ml or more than 80 ml will be defined as abnormal	30 days after the administration of the first and second doses of vaccine
Duration of the menstrual cycle	In women of reproductive age, any duration shorter than 3 days or longer than 7 days will be defined as abnormal	30 days after the administration of the first and second doses of vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-menopausal bleeding	Any bleeding occurred in post-menopausal women	30 days after the administration of the first and second doses of vaccine

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): October 10, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Menstrual Irregularity; Covid-19 vaccine; Menopausal Bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Uterine Diseases; COVID-19; Menstruation Disturbances; Hemorrhage; Uterine Hemorrhage
• Other Study ID Numbers: MECOVAC-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No