COVID-19 Clinical Trial
— MECOVAC-1Official title:
Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Verified date | October 2022 |
Source | Università degli Studi dell'Insubria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 369 |
Est. completion date | December 30, 2021 |
Est. primary completion date | October 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Insubria | Varese |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi dell'Insubria |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Post-menopausal bleeding | Any bleeding occurred in post-menopausal women | 30 days after the administration of the first and second doses of vaccine |
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