What is it about?

Menstruation and the overall menstrual cycle play an important role in the health, human rights, and wellbeing of people who menstruate; however, the study of menstrual health continues to suffer from a lack of funding, and research is often not integrated across the biological, clinical, public health, and social sciences. To help establish a complete, systemic, and holistic understanding of menstrual health, we examined the ways researchers measure changes to the menstrual cycle, including changes in bleeding patterns, characteristics of blood and other fluid, experiences of menstrual pain, and how menstruation affects people’s quality of life. We searched literature and measurement databases across different fields of study and included menstrual changes caused by any factor, such as diseases and disorders, environmental exposures, diet and exercise, or contraceptive use. This paper reports on the measurement tools we found—everything from questionnaires to pictorial and pain scales¬ to laboratory assays measuring menstrual blood loss—and on the quality of these approaches and their usefulness in future clinical trials. We found over 174 articles reporting on 94 measurement approaches, each with varying strengths and limitations. Our findings led us to conclude there is an unmet need for quality approaches to thoroughly measure changes to the menstrual cycles for researchers to use across fields, especially in clinical trials.

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Why is it important?

During clinical trials, it is standard practice to assess how the drug or device being studied impacts the functioning of different parts of the body; however, the menstrual cycle is often left out of these studies despite its importance and consideration by many to be a vital sign. Our paper details what measurement approaches exist, what is needed to more accurately measure menstrual changes during clinical trials, and how to better center and use the perspectives of people who menstruate themselves to inform these approaches.

Perspectives

During the roll-out of COVID-19 vaccines, many people who menstruate experienced changes to their menstrual cycles. Because information on the menstrual cycle is not routinely collected in clinical trials, we saw many of these people dismissed by providers, and this lack of data led to the spread of misinformation about the vaccine. Although it took time to screen the almost 8,500 articles we needed to review to get to the 174 that were relevant to our work, we remained motivated by knowing our work could guide the development of better measurement approaches for assessing changes to the menstrual cycle in clinical trials, ultimately leading to better healthcare for people who menstruate. Additionally, many people who menstruate use contraception, which can also cause changes to the menstrual cycle; however, researchers have not looked at these menstrual changes in a standardized way, which makes comparisons between contraceptive methods and individuals difficult. Better measurement of these menstrual changes is important because many people choose to continue, stop, or change their contraception based on how methods impact their menstrual cycles. Therefore, we hope this work will also be useful for researchers who may be developing new contraceptive methods, as well as those who are interested in how people experience menstrual changes related to contraceptive use.

Amelia Mackenzie
FHI 360

Read the Original

This page is a summary of: Measurement of changes to the menstrual cycle: A transdisciplinary systematic review evaluating measure quality and utility for clinical trials, PLoS ONE, July 2024, PLOS,
DOI: 10.1371/journal.pone.0306491.
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