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

COVID-19 Clinical Trial

— MECOVAC-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083065
• Other study ID #: MECOVAC-1
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2022
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• COVID-19
• Hemorrhage
• Menstrual Irregularity
• Menstruation Disturbances
• Uterine Hemorrhage
• Vaccine

Intervention

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)

Locations

Country	Name	City	State
Italy	University of Insubria	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

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