Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine

Conditions
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COVID-19, Vaccine, Menstrual Irregularity, Menopausal Bleeding

Intervention / Treatment
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* Biological: Covid-19 vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women who underwent Covid-19 vaccination<br>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<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19 vaccine, Menstrual Irregularity, Menopausal Bleeding