Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Frequency of the menstrual cycle
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
排除标准
- •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.
结局指标
主要结局
Frequency of the menstrual cycle
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Post-menopausal bleeding(30 days after the administration of the first and second doses of vaccine)
研究者
Antonio Simone Laganà
Principal Investigator
Università degli Studi dell'Insubria