Breakthroughs Blog: Maternal health

International Women’s Day calls for action to address biases, discrimination, and inequities that continue to impact the quality of life of women and girls, including their access to healthcare, such as malaria prevention and treatment. Pregnant women and their babies are among the most at risk from malaria, and this is exacerbated by their limited access to antimalarial medicines. According to the World Health Organization (WHO), in 2020, nearly 12 million pregnant women were exposed to malaria, and they are particularly vulnerable as pregnancy can weaken their immune system. Malaria can have devastating effects on pregnant women and infants, from mothers with severe anemia and babies born with low birth weight to, in the worst case, the death of the mother and/or baby. According to research from 2020, one in ten maternal deaths in malaria-endemic countries is the result of malaria. WHO recommends intermittent preventive treatment in pregnancy (IPTp) to prevent malaria in pregnancy. Ideally, eligible pregnant women should receive three doses of sulfadoxine-pyrimethamine (SP) to prevent malaria in their second and third trimesters for optimal protection. Due to several factors, only 32 percent of eligible pregnant women received all three recommended doses of IPTp in the 33 sub-Saharan African countries assessed by WHO’s 2021 World Malaria Report. A 2019 review that looked at determinants of IPTp uptake in 18 sub-Saharan African countries found that poor policy implementation resulting from weak coordination between national malaria control and reproductive health programs and stockout of quality SP were the main barriers. The review also mentioned the pivotal role played by health providers in delivering IPTp, highlighting the correlation between their awareness of the policy and the IPTp coverage. In sub-Saharan Africa, between 70 and 90 percent of pharmaceuticals are imported, making it difficult to ensure a steady supply of treatments like SP. To help remedy this access gap, Medicines for Malaria Venture (MMV) is currently leading a UNITAID-funded project to enable the pharmaceutical companies Universal Corporation Ltd (Kenya), Swipha/Biogaran (Nigeria) and Emzor (Nigeria) to manufacture quality SP, not only for domestic use, but also for other countries in Africa. Community IPTp (C-IPTp) is another solution to help address the access gap, in which pregnant women visit “purposely trained and supervised, easily accessible community health workers” close to their homes to receive IPTp. C-IPTp is being explored by many countries with promising results in improving SP uptake. MMV is also involved in Transforming Intermittent Preventive Treatment for Optimal Pregnancy, otherwise known as TIPTOP, a Jhpiego-led project to increase the number of women able to benefit from C-IPTp.Under the umbrella of the Roll Back Malaria Partnership, MMV is participating in a signature campaign calling for global leaders to Speed Up Scale-Up IPTp through an open letter that asks for increased funding to address malaria in pregnancy, proper training for health care workers and the removal of the previously mentioned barriers to seeking care. Beyond statistics: Surviving malaria in pregnancy The need for new options for medicines is underscored by Eileen Buxton’s experience. Eileen, a Ghanaian nurse, was already aware of the risks of malaria in pregnancy as a health care worker in an endemic country. After falling ill while pregnant herself, Eileen “was scared… I knew how being sick during pregnancy could affect the mother and the child too.” She was admitted to a hospital for treatment. After her release, however, the fever came back within a couple of days. Eileen was experiencing severe malaria and had to be admitted to the hospital again, this time for about three weeks. “It took a long time for me to recover some strength,” she recalls. Despite this harrowing experience, Eileen can be described as one of the fortunate ones: after her recovery, she gave birth to healthy twin babies. Millions of women are not so lucky. Scaling up IPTp-SP access will prevent millions of women from going through experiences like Eileen’s. While International Women’s Day highlights women’s achievements, it is also a reminder of the existing challenges they face. When it comes to health and malaria specifically, it is also a reminder that we have not yet reached equity. Ending malaria means working to provide access to antimalarial prevention and scaling up access to IPTp and other treatment methods that are effective and safe for all people—like Eileen Buxton—who are most at risk. Ultimately, that’s a win for everyone. We urge you to add your name to the open letter and help protect more mothers and babies from malaria.

This blog is authored by Abena Poku-Awuku, Silvia Ferazzi, Katya Halil, and Maud Majeres-Lugand of Medicines for Malaria Venture; Valentina Buj de Lauwerier, Clara Pons-Duran, and Joanna Lai of UNICEF; and Clara Menéndez and Raquel González of ISGlobal.From the turn of the millennium until 2015, the global health community has successfully reduced malaria-related deaths by 60 percent and decreased the likelihood of malaria infection among the 3.4 billion people at risk. However, since then, progress has stalled, and in 2019, malaria claimed the lives of approximately 409,000 people, 90 percent of whom lived in sub-Saharan Africa (SSA).As children under 5 years of age and pregnant women are the hardest hit by the disease, most efforts are targeted at protecting these groups. It has been widely reported that malaria still kills a young child every two minutes in SSA. However, less well-known is that, as of 2016, malaria was also the second major cause of death and ill health, after HIV/AIDS, in younger adolescent girls aged 10–14 in the region. Malaria was also the eighth cause of death and the fifth leading cause of ill health among all adolescent girls in SSA. Furthermore, while gains were made in global malaria control between 2012 and 2016, especially among children under the age of 5, little progress was made in reducing malaria-related deaths among adolescents. The protection of populations such as adolescents, and particularly girls, has been largely overlooked due to lack of age- and sex-disaggregated data. For instance, the most recent publicly available data on malaria-related death and ill health among adolescents is from 2016. ISGlobal, Medicines for Malaria Venture, and UNICEF are collaborating to raise awareness of the lack of evidence and information on the vulnerability of adolescent girls to malaria, as well as bring attention to the specific challenges adolescent girls face in accessing malaria protection and treatment interventions.Why are adolescent girls more at risk of malaria?Biologically, younger adolescent girls and pregnant adolescents, especially those in their first pregnancies, have been found to be at higher risk of malaria and anemia than adolescent boys and older pregnant women. An estimated 777,000 girls under the age of 15 and 12 million girls aged 15–19 get pregnant each year in developing regions; malaria and associated anemia can be deadly for both the young mother, her fetus, and her newborn child.Socially, in many malaria-endemic countries, gender-based roles and household hierarchies, as well as the false notion of being less vulnerable to the disease, all raise an adolescent girl’s risk of being infected with malaria. Moreover, adolescent girls often do not have financial resources, may be unaware of their civil rights, and lack information about the disease. Age-of-consent policies equally prevent adolescents, both boys and girls, from seeking health services without the consent of a parent or guardian, or a spouse in the case of girls.The situation is exacerbated when a girl becomes pregnant, because she is less likely to access services due to cultural bias and stigma. For instance, intermittent preventative treatment of malaria in pregnancy is an antenatal care intervention recommended by the World Health Organization (WHO) in SSA to protect all pregnant girls and women against malaria. However, reaching pregnant adolescents with this intervention is difficult, as they are less likely to access antenatal services than women and older adolescents due to societal stigma.Furthermore, when a pregnant girl or woman becomes infected with malaria, very few effective malaria treatment options are available to her. Artemisinin-based combination therapies for P. falciparum malaria, the most common form of malaria in SSA, have only recently been considered by WHO for the treatment of malaria during first-trimester pregnancy, but WHO emphasizes the need for continued monitoring of drug safety, birth outcomes, and death among newborns. In addition, P. vivax malaria, a form of malaria that is predominantly found in Southeast Asia and Latin America, has now been found across Africa and is increasingly growing in parts of East Africa. However, the existing radical cure for relapsing P. vivax malaria is not recommended during pregnancy. Moreover, the development of new antimalarials for pregnant girls and women is constrained, because current drug development processes actively exclude pregnant women and girls during the development of new antimalarial drugs. This hinders the generation of data and creates evidence gaps in the treatment of malaria in pregnant women and girls. Insufficient funding is also a major limiting factor to the research and development (R&D) of new antimalarial drugs for pregnant girls and women. Engaging policymakers and the wider malaria communityBased on existing, but limited, evidence, we urge policymakers and the wider malaria community to join forces in: Developing adolescent-friendly school- and community-based services that facilitate improved outreach to adolescent girls and take into consideration their perspectives and needs. Increasing resources for information, education, and communication on the impact of malaria will also be impactful.Working together with local communities and health workers to build safer environments that encourage girls to access health services, including malaria and reproductive health interventions. Advocating against early marriages and early pregnancies, as key compounding obstacles to a self-determined and healthy, disease-free life.Maintaining the continuum of care for pregnant girls through preconception, prenatal, and postnatal stages to ensure that malaria is eliminated in this group. Supporting the generation of updated and in-depth evidence to back the development and re-evaluation of policies and programs targeting adolescents and focusing on gender equity. Revising national policies that set age limits and create barriers to accessing health services and malaria interventions. Increasing funding for malaria R&D projects to design effective interventions for pregnant girls. Developing new approaches, including leveraging new technologies, to facilitate earlier inclusion of pregnant women in clinical trials.

For the second time, the World Health Assembly took place in the midst of an ongoing pandemic that is widening health inequities across and within regions. More than a year after the first wave of the pandemic, health systems in many parts of the world continue to battle waves of infection amid shortages of oxygen, vaccines, and health care workers. Yet among the numerous challenges posed by the pandemic, there were positive signals that with coordinated and focused action, health innovation in record pace is possible, particularly if that action can be built on a firm foundation of existing research and development (R&D). Our next challenge—as we continue the battle against COVID-19 and other health threats—is to channel similar coordinated, focused action to ensure the benefits of innovation are distributed equally across both geography and gender. What happens when years of existing research systematically exclude certain populations, denying them or delaying access to the benefits of health innovation? How can we address the underlying causes and accelerate shifts to make clinical research more inclusive? A recent side event at the 74th World Health Assembly, co-organized by Deutsche Stiftung Weltbevölkerung, Global Health Technologies Coalition, and Medicines for Malaria Venture (MMV), explored the above questions by highlighting the specific issue of gender inequity in health innovation. The panelists at the event discussed how gender biases have resulted in women’s underrepresentation in preclinical and clinical research, leading to downstream gaps in therapeutic options for them. Though gender inequity in health innovation is not limited to malaria, this article builds upon MMV’s presentation at the event, focusing on gender equity in malaria R&D to meet unmet needs. Unlike COVID-19, malaria is a disease that we have known for centuries. Despite the vast amount of scientific and epidemiological knowledge on malaria, a quick glance at the historical trajectory of malaria research reveals that it has been embedded in a larger context of gender bias in medical research. During the clinical development of most new medicines, including antimalarial drugs, pregnant people are actively excluded from trials and, if pregnancy occurs during the trial, treatment is discontinued and follow-up on the pregnancy outcomes is ensured. While this practice aims to protect the pregnant person and the fetus, it also prevents the generation of data and in doing so it has created knowledge gaps in the treatment of malaria in pregnant people. In addition to delaying the benefits of new treatments to these populations, the knowledge gaps also hinder the creation and implementation of gender-sensitive policies to fight the disease.Malaria in pregnancy, and more broadly in people of reproductive potential, remains a major public health challenge today. The World Health Organization estimates that 12 million pregnancies are at risk annually, resulting in nearly 822,000 children being born with low birth weight. Though preventive tools like vector control (for example insecticide-treated bednets and indoor residual spraying) and intermittent preventive treatment in pregnancy exist, there are very few treatment options for pregnant and lactating people in their first trimester. The longer we wait to change our course, not only do we risk losing thousands of pregnant people and babies to a treatable disease, but we also widen the existing knowledge gaps that urgently need to be bridged. In other words, if we delay the process of integrating a gender lens as an essential element of the drug development process, the journey to catch up will be steep and could jeopardize efforts to eliminate and eradicate malaria. Fortunately, there is a growing determination within the malaria community to rectify gender-related data gaps. At MMV, we are doing so through our Malaria in Mothers and Babies (MiMBa) strategy, which aims to systematically prioritize and address the needs of pregnant people and newborns, right from target product profiling at the outset of drug development through to ensuring a stable supply of recommended medicines to treat and protect these populations from malaria. In one example, recognizing the lack of safety and tolerability data for antimalarials used during pregnancy, we have teamed up with the Liverpool School of Tropical Medicine to develop a pregnancy registry to help fill the data gaps with the objective of eventually establishing standard protocols in the treatment of malaria during pregnancy in all endemic regions.Other organizations, like the WorldWide Antimalarial Resistance Network, are building online repositories of published and unpublished literature on malaria in pregnancy, contributing to the methodical archiving of data on this topic. Furthermore, awareness campaigns like “Zero malaria starts with me” are also placing a strong focus on the need for inclusive innovation to treat malaria in pregnancy.In an important step forward, high-level decision-making bodies like the G7 are also taking note of this issue. We welcome the G7 health ministers’ Therapeutics and Vaccines Clinical Trials Charter to pave the way for “stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children.” This is an important step forward toward more equitable clinical research.While great strides are being made in advancing health innovation to better represent and account for the needs of all genders in health care, much critical work remains to be done. Decades of exclusion from clinical research will not disappear overnight. The need of the hour is gender mainstreaming supported by significant investments into R&D, as well as moving policymaking forward, to ensure a fairer and more inclusive health care system for all. Most importantly, while organizations like MMV commit to extend the benefits of our innovation equitably to all populations affected by malaria, we firmly believe that the road to achieving gender equity in clinical research will be paved by the inclusion and support of patients, health workers, researchers, policymakers, as well as the champions and advocates for health equity in the global health system. Much like for the COVID-19 pandemic, catalyzing this transition to a gender-sensitive malaria eradication strategy will require focused and coordinated action and all voices have a part to play.

Becoming a mother can be one of the most rewarding experiences of a woman’s life—but unfortunately, it can also be one of the most dangerous. More than 290,000 women die each year in pregnancy and childbirth, with the vast majority of those deaths occurring in low-income countries.  For decades, the US Agency for International Development (USAID) has been supporting problem solvers to create simple, affordable solutions to protect mothers and their babies during birth. Here are ten amazing USAID-supported innovations to make motherhood safer:  Preeclampsia is a dangerous condition that impacts 1 in 20 pregnancies. Yet its symptoms, headaches and swelling, can be difficult to spot since they mimic those of routine pregnancy. To detect this condition early before it turns deadly, researchers at Ohio State University created the Congo Red Dot test. This inexpensive, easy-to-use test uses a specific red dye in paper that reacts to unique proteins in the urine of pregnant women with preeclampsia, delivering results in just three minutes. Postpartum hemorrhage (PPH), or excessive bleeding post birth, affects millions of women every year and can cause death within hours if left untreated. Too often, lifesaving deliveries of blood and emergency supplies are limited by inadequate transportation, communication, and supply chain infrastructure. To facilitate easy, affordable, and rapid delivery of essential health supplies, several global initiatives, including from Zipline and Matternet, are using unmanned aerial vehicles—or drones—to carry blood and other urgent medicines to rural health facilities.  Argentine car mechanic Jorge Odón was watching a YouTube video about how to remove a cork from inside a wine bottle, when he had an inspiring realization: the same technique could be used to help extract a baby’s head during obstructed labor. This idea led him to create the Odon Device, which uses a plastic sleeve, pumped with air, to safely cushion a baby’s head while it is sucked out. In partnership with BD, Odón is working to advance and test this simple, low-cost innovation that could make it safer and easier to deliver complicated births without the use of forceps or a vacuum extractor.  A uterine balloon tamponade (UBT) is a standard device used in high-income countries to stop postpartum bleeding by putting pressure on the walls of the uterus. But at a cost of hundreds of dollars for a single use, these devices were unaffordable in many low-resource settings. This led health workers to improvise their own devices made from a condom and rubber tubing. Inspired by this ingenuity, PATH and Sinapi created an optimized, quality-assured version of this “condom catheter” called the Ellavi UBT, which at $7.50 per unit is putting this lifesaving device within reach for women around the world.  Blood pressure (BP) disorders like preeclampsia are a leading cause of maternal death. BP cuffs have been used to monitor BP since the early 1900s, but they can be hard to maintain and read by less-skilled health workers. A startup named Biospectal is reinventing this approach with their OptiBP cuff-less smartphone app. By simply placing a finger on a smartphone camera and using the software, anyone anywhere in the world can transform their phone into an instant, medical-grade blood pressure monitoring device.  Blood donation shortages in low-resource communities can leave health workers with few options if a woman is hemorrhaging blood during childbirth. Attendants often resort to using improvised tools like a soup ladle and gauze to try to salvage and recycle a patient’s own blood. The Hemafuse pump, developed by Sisu Global Health, is a cost-effective, hygienic alternative. This innovative tool sucks up blood, filters it, and transfers it to a bag for transfusion back to the patient.  Healthy timing and spacing of pregnancies are critical to the health of mothers and their babies. To expand family planning options, the Population Council developed the long-acting Annovera contraceptive ring—the first and only contraceptive to provide a year of protection while fully under a woman’s control. The soft, reusable silicone ring can be inserted and removed by its user, providing women with the ease of a long-term method and control of a short-term method. The ring does not require refrigeration, making it particularly effective for distribution and use in low-resource settings.  Poor water and sanitation in low-resource health facilities can expose moms and their babies to dangerous infections at birth. Chlorine is a commonly used disinfectant, but supply chain issues make it hard for facilities to ensure a steady, reliable supply. To help address this problem, PATH and MSR Global Health created a portable, low-cost tool—the SafiStation Chlorine Generator—that can produce chlorine on site using just water, salt, and electricity.  In high-income countries, an infusion pump is a common technology used to intravenously deliver medications or fluids. But it requires electricity—a luxury not always present in maternity clinics worldwide. To solve for this challenge, PATH innovators sought to create a low-cost, rugged infusion pump that could function without electricity or batteries. After testing different tactics, they settled on a simple approach to power the device: a hand-powered bicycle pump. Called the RELI Delivery System—short for reusable, electricity-free, low-cost, infusion delivery—this innovative device can power a consistent fluid delivery rate, over the equivalent of one clinic shift, with just a few pumps.  PPH, the world’s leading cause of maternal mortality, overwhelmingly affects mothers in low- and middle-income countries. The gold standard therapy for prevention and treatment of PPH, oxytocin, currently exists only as an injection—requiring refrigeration and skilled health care workers for administration. The Monash Institute of Pharmaceutical Sciences, in partnership with Janssen Pharmaceutica NV and GlaxoSmithKline, is developing a heat-stable, inhaled form of oxytocin to improve access to this lifesaving therapy to women in low-resource settings.  Photos, from top: Ohio State University Wexner Medical Center, Paul Kagame, Ministerio de Ciencia, Sinapi Biomedical, Biospectal, Sisu Global Health, Bedsider Providers, PATH/Adam Drolet, PATH/Tom Furtwangler, Monash Institute of Pharmaceutical Sciences