COVID-19, Menopausal Bleeding, Menstrual Irregularity, Vaccine
Conditions
Keywords
Covid-19 vaccine, Menstrual Irregularity, Menopausal Bleeding
Brief summary
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.
Interventions
BIOLOGICALCovid-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)
Sponsors
Università degli Studi dell'Insubria
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of the menstrual cycle | 30 days after the administration of the first and second doses of vaccine | In women of reproductive age, any frequency shorter than 25 days or longer than 36 days will be defined as abnormal |
| Quantity of the menstrual cycle | 30 days after the administration of the first and second doses of vaccine | In women of reproductive age, any quantity less than 30 ml or more than 80 ml will be defined as abnormal |
| Duration of the menstrual cycle | 30 days after the administration of the first and second doses of vaccine | In women of reproductive age, any duration shorter than 3 days or longer than 7 days will be defined as abnormal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-menopausal bleeding | 30 days after the administration of the first and second doses of vaccine | Any bleeding occurred in post-menopausal women |
Countries
Italy
Outcome results
None listed