MECOVAC-1: Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | 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)
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Post-menopausal bleeding [30 days after the administration of the first and second doses of vaccine]
Any bleeding occurred in post-menopausal women
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Università degli Studi dell'Insubria
Investigators
- Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MECOVAC-1