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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covid-19 vaccine | Biological |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà, M.D., Ph.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Insubria | Varese | Italy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |