Recruiting open for study on COVID-19 vaccines and menstrual health

COVIDmenses is recruiting participants for a study to examine potential effects of COVID-19 vaccination on menstrual health.

While the initial COVID-19 clinical trials for the Pfizer, Moderna, and Johnson & Johnson vaccines did not monitor impact on menstruation, some women reported changes in their cycles following vaccination, such as spotting, heavy bleeding, and irregular or missed cycles.1

Led by the gynecology team at Johns Hopkins University, Baltimore, Maryland, COVIDmenses will contribute to existing research to improve our understanding of the potential effects of COVID-19 vaccines on menstruation. The results may allow ob-gyns to better counsel patients on possible side effects and effectively reduce vaccine hesitancy and increase enrollment rates.1

The National Institutes of Health awarded 1-year supplemental grants totaling $1.67M to 5 institutions in August 2021 to explore potential links between COVID-19 vaccination and menstrual changes. Boston University, Harvard Medical School, Michigan State University, and Oregon Health and Science University are also conducting the research.1

Researchers are enrolling participants between the ages of 18 and 55 who have experienced at least 1 menstrual cycle in the past 12 months. Participants must be interested in receiving their first dose of a COVID-19 vaccine or a COVID-19 booster dose in the near future. The study does not provide the vaccine and the research team will not provide any related guidance on whether to receive the vaccine.

COVIDmenses will be conducted virtually from the United States over the course of 100 days, during which participants will document various details of their menstrual cycles. They will be asked to record 1 menstrual cycle before receiving the COVID-19 vaccine or booster and 2 to 3 cycles after receiving the vaccine.

Using a validated menstrual diary, women will record the number of pads or tampons she used, or the volume of blood in a marked menstrual cup, each day. Researchers will collect the information with a short survey via text message. In addition to questions about blood volume, participants will also answer about potential confounders that may impact the menstrual cycle, like hormonal therapy and weight fluctuation.

For more information, visit COVIDmenses.org. 

Reference

  1. Item of Interest: NIH funds studies to assess potential effects of COVID-19 vaccination on menstruation. https://www.nichd.nih.gov/. Published August 30, 2021. Accessed December 7, 2021. https://www.nichd.nih.gov/newsroom/news/083021-COVID-19-vaccination-menstruation