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

Completed

• Conditions: COVID-19; Menstrual Irregularity; Vaccine; Menopausal Bleeding
• Interventions: Biological: Covid-19 vaccine

• Registration Number: NCT05083065
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-10
• Primary Completion: 2021-10-10
• Study First Submitted: 2021-10-17
• Study First Submitted QC: 2021-10-17
• Study First Posted: 2021-10-19
• Study Completion: 2021-12-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 369

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women who underwent Covid-19 vaccination	Covid-19 vaccine	This group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used.

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
Post-menopausal bleeding	30 days after the administration of the first and second doses of vaccine	Any bleeding occurred in post-menopausal women

Trial Locations

Locations (1)

University of Insubria; 🇮🇹 Varese, Italy