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Technical Consultation on Contraceptive-Induced Menstrual Changes

New Perspectives on Research that Can Improve Women’s Lives Globally

On November 17‒18, 2020, a virtual technical consultation on contraceptive-induced menstrual changes (CIMCs) convened experts in the fields of family planning and menstrual health. This meeting was coordinated by FHI 360 through the Research for Scalable Solutions (R4S) and Envision FP projects with support from the U.S. Agency for International Development (USAID). Materials and resources from the CIMCs meeting are now available for download. You can find slides from Day 1 here and slides from Day 2 here; the recordings are located in this post.

Virtual Technical Consultation on contraceptive induced menstrual changes

Contraceptive-induced menstrual changes (CIMCs) can affect users’ lives in both positive and negative ways, resulting in both consequences and opportunities. However, the family planning (FP) and menstrual health (MH) fields often do not adequately incorporate these considerations into research, programs, policies, and product development. FHI 360 is leading the way in understanding the impacts of CIMCs on users’ lives and exploring approaches to address these, which led to a technical consultation on CIMCs held in November that convened participants, presenters, and panelists from a wide variety of perspectives and stakeholder groups. Presentations covered topics related to CIMCs and contraceptive research and development, biomedical research, social-behavioral research, implementation science, policy, and programs. The meeting also reflected four crosscutting themes: expanding choice, gender, self-care, and changing needs throughout the life course. The event resulted in engaging discussions, including the following:

Choice, Self-care, Gender and Needs across life course
  • Choice: The idea of expanding choice, essential for both FP and MH, shaped this meeting significantly. In MH, it is important to provide choice for menstrual products and facilities in order to address the unique needs of every menstruator. In FP, providing full contraceptive method choice and the option to voluntarily choose among a variety of methods with multiple product attributes is essential to meeting users’ needs and preferences. A new concept called “menstrual choice” was introduced and discussed, that is people who menstruate should be able to have the menstrual cycle experience they want or need, which means including informed choice about how some contraceptives can be used to manage if, when, and how much to menstruate. While there may not be consensus from all perspectives on this concept, the CIMC meeting introduced a conversation about menstrual choice that will continue as part of follow-up activities.
  • Gender: Improving gender equity is important to advance both MH and FP outcomes, but it is often overlooked or taken for granted in both fields. Throughout the November meeting, presenters and participants pointed to the importance of understanding and acknowledging the sociocultural context and impact of gender norms on attitudes and perceptions related to CIMCs. This area requires more research.
  • Self-Care: The World Health Organization (WHO) defines self-care as the ability of individuals, families, and communities to promote health, with or without the support of a health care provider, which is central to both FP and MH. Several presenters gave examples of how self-care can help promote effective FP‒MH integration. For example, during a panel on seeking synergies, experts explained that providing young people with puberty education that includes information about the menstrual cycle can improve their ability to communicate about reproductive health (RH) and more easily access services such as FP later in life. Another presentation, given during the programmatic panel, illustrated how a new tool, the NORMAL job aid, provides guidance to providers on how to counsel FP users on CIMCs including strengthening opportunities for self-care. The NORMAL tool is currently being adapted into a community-based version.
  • Life Course: A life course approach is essential to the conversation about CIMCs. Individuals’ needs and preferences regarding FP use often change throughout their lifetime. Likewise, menstruators have difference experiences during their lives. Despite this, the MH sector often focuses narrowly on youth, which may exclude a large population of menstruators and FP users from programmatic interventions and cause missed opportunities for integration. Presenters and panelists explained that to integrate MH and FP and address CIMCs, researchers, clinicians, and policymakers will need to consider the changing experiences and preferences of users in many stages of life, from menarche to menopause.

Exploration of these crosscutting themes, as well as the presentation and panel topics, provided an opportunity to facilitate new and increased connections between the FP and MH fields and spark a conversation on this multifaceted topic. The overall goal was to contribute to the development of a research agenda and a wider “call to action” for CIMCs, which began during the consultation and is continuing collaboratively now. If you are interested in joining these efforts, contact the meeting coordinators. The eventual call to action will be based on the presentations and discussions from the Virtual Technical Consultation on Contraceptive-Induced Menstrual Changes. The meeting content and resources are detailed below.

Introduction and Rapid Review of CIMCs

Watch now: (0:00:00 – 0:31:15)

Tabitha Sripipatana, USAID​; Laneta Dorflinger, FHI 360; Marsden Solomon, Chief of Party, Afya Uzazi project, FHI 360/Kenya

CIMCs have consequences. They can lead to nonuse, dissatisfaction with methods, and discontinuation of contraceptives. Studies have found that 20–33% of unmarried women with unmet need report not using contraception because they are concerned about side effects, including menstrual and bleeding changes. However, CIMCs may impact users’ lives in positive ways as well, resulting in opportunities. For example, contraceptives can be used to treat menstrual disorders such as heavy bleeding and to prevent or improve health conditions such as anemia. They can also provide lifestyle benefits, offering users more freedom to participate in daily activities and reducing the burden of purchasing menstrual products each month. Presenter Tabitha Sripipatana noted that it is important to recognize and address both these potential consequences and opportunities of CIMCs.

Contraceptive-induced menstrual changes word cloud

Presenter Laneta Dorflinger pointed out that while CIMCs are common, they are not defined consistently by either the FP or MH fields. As of now, terminology has depended on discipline and background, but CIMC was proposed during the meeting as a term that can be used across the fields. This is because it broadly captures the changes that contraception may cause to a users’ standard menstrual cycle and is inclusive of how menstruators view these changes. Additionally, the term CIMC encompasses a range of possible changes that vary from user to user, including duration, volume, frequency, and predictability of bleeding; blood consistency, color, and smell; uterine cramping and pain; other symptoms associated with menstruation and phases of the cycle; as well as changes over time and after discontinuation. Presenter Marsden Solomon explained that different types of contraceptives are generally associated with certain types of changes. For example, contraceptive pills are commonly associated with shorter and lighter bleeding and reduced cramping and pain, while the copper IUD is often associated with heavier and longer bleeding after initiation of method use.

Seeking Synergies between Menstrual Health and Family Planning

Watch now: (0:31:35 – 0:45:41)

Marni Sommer, Columbia University; Lucy Wilson, Rising Outcomes

Linkages between Menstrual Health (MH) and Reproductive Health (RH)

The MH and FP sectors overlap in many ways, which can provide opportunities for linking and integrating beyond addressing CIMCs. For example, MH can be an important and early entry point for RH information and services, including FP. As Sommer stated in her presentation, “Increased attention to MHH [menstrual health and hygiene] presents opportunity to the family planning field for early, comprehensive, and lifelong provision of information and support to address concerns about contraception and CIMCs, and to optimize ability to manage reproductive and sexual health decision-making over the life course.” Additionally, presenter Lucy Wilson pointed out that early access to information about menstruation and RH can decrease stigma and improve self-efficacy, which can remove barriers to education and improve RH overall, including access to FP (pictured). Overall, the two sectors should begin to work together now to collect more MH data and evaluate integrated programs, strengthen implementation of comprehensive sexuality education, and support health care providers to discuss menstruation, menstrual disorders, CIMCs, and management options.

User Experiences and Perceptions

Watch now: (0:46:03 – 1:21:32)

Chelsea Polis, Guttmacher Institute; Amelia Mackenzie, FHI 360; Simon Kibira, Makerere University; facilitated by Funmi OlaOlorun, Evidence for Sustainable Human Development Systems in Africa (EVIHDAF)

The experiences and preferences of contraceptive users span a wide range globally and, at times, represent unexpected views and attitudes. A recent scoping review authored by Chelsea Polis and colleagues (2018) found that (1) preferences related to nonstandard bleeding frequencies like amenorrhea range widely across countries and are viewed negatively in some studies and positively in others; (2) CIMCs are a major reason for contraceptive nonuse, dissatisfaction, or discontinuation; and (3) users often link CIMCs with health risks and categorize them as side effects.

Since this review was conducted, additional data have been collected on user experiences in a variety of settings, including during or as add-on studies to contraceptive clinical trials and during large national/cross-national surveys. For example, Amelia Mackenzie shared results from research FHI 360 conducted recently: (1) bleeding profiles vary widely and depend on the method and the user; (2) consistent, complete, and clear counseling is one avenue to increase knowledge of menstrual changes but it is not being provided widely; and (3) users perceive different types of CIMCs differently depending on a variety of factors including context. Additionally, Simon Kibira reported that researchers in Uganda combined a variety of data types (national/cross-national, clinical, and qualitative) to examine user preferences and attitudes regarding CIMCs and found that (1) bleeding changes are a challenge for many women and have consequences, including psychological and financial implications as well as contraceptive discontinuation, and (2) it is important to consider specific side effects individually and in varied social, economic, and cultural settings. Overall, more research on user experiences is needed, but thus far has shown that CIMCs have consequences and preferences depend greatly on context.

Programmatic Interventions – Existing Knowledge and Evidence Gaps

Watch now: (1:21:52 – 1:55:45)

Kate Rademacher, FHI 360; Francia Rasoanirina, Expanding Effective Contraceptive Options (EECO) – Population Services International (PSI)/Madagascar; Sofía Córdova, PSI Central America; Roopal Thaker, ZanaAfrica; facilitated by Eva Lathrop, PSI​

Programmatic interventions that integrate FP and MH and address CIMCs are limited and in the early stages of development. However, several organizations are beginning to explore these connections and collect data and evidence to support their implementation. These include:

  • NORMAL counseling tool (developed in partnership with FHI 360 and PSI) is a job aid that guides providers on key messages about CIMCs to help users make fully informed method decisions. Qualitative interviews were conducted in Malawi among providers who used the tool. Further development and research to create a lower literacy, community-based version is currently being planned in Kenya.
  • Demand creation for Avibela through the EECO project in Madagascar. The EECO project, which is funded by USAID and led by WCG Cares in collaboration with PSI, introduced the hormonal IUS to potential users in Madagascar through communications that promoted it as providing freedom, peace, and the “solution to period problems.” Follow-up evaluations showed new user’s reasons for choosing the IUS included a desired bleeding profile (23%) and desired side-effects profile (26%).
  • ZanaAfrica Kenya’s school-based integrated MH and RH programming provides MH products, referrals to trusted RH services, and education through a 25-session health and life skills curriculum, supplemented with story-based print materials. Results from a randomized controlled trial (to be published in early 2021) showed improvements in knowledge about modern contraceptive methods among schoolgirls with an average age of 14, as well as positive changes to harmful gender norms and related attitudes.
  • PSI Latin America’s digital education for youth has provided RH information using cyber educators and chatbots through more than 500,000 messages resulting in more than 2,000 referrals to care so far. The project has found that posts addressing MH have a 20% increase in engagement.

Measurement and Indicators

Watch now: (0:09:36 – 00:25:56)

Julie Hennegan, Burnet Institute; Aurélie Brunie, FHI 360; facilitated by Emily Hoppes, FHI 360

Biological Changes Infographic

Measurement is a key component for moving the CIMC research agenda forward, starting with considering both what we measure and how it is measured. As presenter Julie Hennegan explained, for a long time, the MH field measured menstrual practices (i.e., types of products and facilities used) but largely ignored menstruators’ perceptions of these practices, which also has a significant impact on health outcomes. Additionally, for years, the tools used to measure MH needs and programmatic outcomes varied widely and were not comparable across projects. These are important lessons learned as we begin to create a measurement framework for CIMCs. For example, FHI 360 has begun to develop a framework (pictured) that includes measuring not only biological changes (i.e., amount and frequency of bleeding) but also user’s perceptions and attitudes about these changes, and how these categories combine to affect contraceptive use, MH practices, and users’ lives. Aurélie Brunie introduced this model during her presentation and called on those working in FP and MH to begin to standardize measures and collaborate to integrate across measurement domains.

Biomedical Interventions and CIMCs

Watch now: (0:26:25 – 1:00:06)

Jackie Maybin, University of Edinburgh; Kavita Nanda, FHI 360; with discussant Bellington Vwalika, University Teaching Hospital in Lusaka and University of Zambia School of Medicine; facilitated by Lisa Haddad, Population Council

Biomedical interventions and CIMCs have several areas of interest: (1) the use of contraceptives to treat menstrual disorders and (2) methods for preventing undesirable or accelerating desirable CIMCs. Jackie Maybin presented on menstrual disorders and the wide range of issues they cause, including heavy menstrual bleeding (menorrhagia), endometriosis, and fibroids. These conditions are under-researched resulting in limited treatment options. Hormonal contraceptives are a comparatively effective and commonly prescribed treatment. For example, the hormonal IUS can reduce heavy menstrual bleeding significantly over time. In general, more research is needed to understand the mechanisms and diagnosis of menstrual disorders, to expand treatment options, and to examine additional ways in which contraceptives can be used to benefit those with menstrual disorders.

Similarly, and as presenter Kavita Nanda explained, the biological mechanisms of CIMCs are not well understood and require additional foundational research. Temporary treatment for bleeding changes include nonsteroidal anti-inflammatory drugs (NSAIDs), antifibrinolytics, ethinyl estradiol, and continuous oral contraceptives (COCs); all of which can and should be provided along with counseling, which can help improve satisfaction and continuation of FP methods. Due to the limited number of options for CIMC treatment, the prevention of adverse endometrial changes and the acceleration of amenorrhea might be an option that should be the focus of future research.

Product Development Panel – Forward-Looking Innovations

Watch now: (1:00:34 – 1:30:15)

Gustavo Doncel, Contraceptive Research and Development (CONRAD); Kirsten Vogelsong, Bill & Melinda Gates Foundation (BMGF); Diana Blithe, National Institute of Child Health and Human Development (NICHD); and Laneta Dorflinger, FHI 360; facilitated by Amelia Mackenzie, FHI 360

Contraceptive product development leaders are not only thinking about the bleeding preferences and contraceptive desires of people who menstruate now, but also what the preferences and needs will be of people 10 or more years from now. Diana Blithe started the conversation by demonstrating how a contraceptive vaginal ring worn either continuously or in cycles produced different patterns of bleeding for every woman, which is challenging for counseling and bringing menstrual changes women may want. This may call for personalization of long-acting contraceptives, which Gustavo Doncel is currently researching a pellet-based implant that uses a safe, flexible inserter. A woman’s medical history may determine which contraceptive compounds go into the pellet. Laneta Dorflinger and her teams are working on consistent drug release in novel products such as a microneedle patch, biodegradable implants, and long-acting injectables. Kirsten Vogelsong reiterated the Gates Foundation goal to meet the preferences of women in low-resource settings. Along with hormonal product development, the Foundation is prioritizing drug discovery tools used in other health fields and nonhormonal contraceptive drug discovery. Nonhormonal contraceptive drugs would act on a woman’s body differently than the products that exist today, and bleeding effects are being considered in the earliest stages of development.

Development of Learning Agenda and Call to Action

Watch now: (1:43:21 – 2:03:15)

Gustavo Doncel, Contraceptive Research and Development (CONRAD); Kirsten Vogelsong, Bill & Melinda Gates Foundation (BMGF); Diana Blithe, National Institute of Child Health and Human Development (NICHD); and Laneta Dorflinger, FHI 360; facilitated by Amelia Mackenzie, FHI 360

Foundational work and thought leadership are immensely needed to inform future research, programs, and policies for CIMCs. During this meeting, participants were asked to brainstorm and discuss the future of this work in small groups. Their excitement and creativity led to key takeaways that are being used to inform a “call to action.” Suggestions included:

  • Larger sociocultural contexts and norms need to be considered when developing indicators, measures, and research questions, especially in examining user experiences and attitudes
  • Roles and perspectives of health care providers are an essential component that should be incorporated into the learning agenda, including providers at all levels​
  • Needs, perspectives, and experiences related to both MH and FP differ greatly depending on age and life stage; these differences should be explored in future research
  • Strong interest exists for the ability to predict CIMCs for patients before they even begin to use a contraceptive; potential predictive factors to explore include genetic markers, microbiome, and lifestyle
  • Self-care is important to consider but because self-care can happen beyond the individual, peer-to-peer and community-based self-care might be important to explore for managing CIMCs
  • MH programming can be an important entry point and conversation starter for other RH programming and services, including FP

The research and learning agenda being developed will explore user experiences and the social-behavioral aspects of CIMCs, as well as recommendations for contraceptive research and development and biomedical research related to CIMCs. The agenda will be supported by a detailed measurement and equity framework and will be used to inform service delivery considerations including for the integration of MH and FP.

If you would like to be engaged in this process or use the resulting agenda to inform your work, please reach out to the meeting organizers.

Selected Tools and Resources

Materials and resources from the CIMC meeting are now available for download. You can find slides from Day 1 here and slides from Day 2 here; the recordings and a compilation of written question and answer responses from event panelists are located in this post. The following resources from the meeting’s presenters are also available:

Emily Hoppes

Technical Officer (Product Development and Introduction), FHI 360

Emily Hoppes is a Technical Officer on the Product Development and Introduction team in the Global Health, Population and Nutrition group at FHI 360. Emily has more than 8 years of experience designing and implementing HIV prevention, menstrual health, and SRH programs across East Africa. In her role at FHI 360, she is contributing to the family planning strategy through management of the CTI Exchange and a variety of other activities, including work to better integrate family planning and menstrual health.

Reana Thomas

Technical Officer, Global Health, Population and Nutrition, FHI 360

Reana Thomas, MPH, is a Technical Officer in the Global Health, Population, and Research department at FHI 360. In her role, she contributes to project development and design and knowledge management and dissemination. Her areas of specialization include research utilization, equity, gender, and youth health and development.

Kate Rademacher

Senior Technical Advisor (Product Development and Introduction), FHI 360

Kate H. Rademacher is an innovative public health leader with 18 years of experience in family planning program design, management, and evaluation. She currently works on the Product Development and Introduction team in the Global Health, Population and Nutrition group at FHI 360, where she co-leads FHI 360’s family planning strategy and supports the development and introduction of new and underutilized contraceptives in low-resource settings. She is the project director for the Learning about Expanded Access and Potential (LEAP) Initiative and oversees a portfolio of activities under the USAID-funded Envision FP and Innovate FP projects.