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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-10

Study Completion Date

2021-12-30

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.

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Detailed Description

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Conditions

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COVID-19 Vaccine Menstrual Irregularity Menopausal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Covid-19 vaccine

Intervention Type BIOLOGICAL

* 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)

Interventions

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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)

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes