Breakthroughs Blog: Maternal health

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 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.The United Kingdom’s Medicines Healthcare products Regulatory Authority on Wednesday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use across the country. The United Kingdom has a supply deal for 40 million doses of the vaccine, enough for 20 million people, which it will begin to distribute in the upcoming days to priority groups including care home residents, health and care staff, the elderly, and populations that are clinically extremely vulnerable. The mRNA-based vaccine, which was shown to have 95 percent efficacy in phase 3 trials, requires a strict cold chain and will be delivered through a network of 50 hospitals, as well as specialist vaccination centers, and any general practitioners and pharmacists that have cold storage capacity. The US Food and Drug Administration (FDA) and the European Medicines Agency are expected to finalize their reviews of the vaccine candidate within the next few weeks.A major federal advisory committee in the United States voted Tuesday that health care personnel and people who live in long-term care facilities should receive priority in COVID-19 vaccine distribution. However, the Advisory Committee on Immunization Practices (ACIP) also acknowledged that pregnant health care workers, who make up about 330,000 members of the workforce, are at heightened risk of COVID-19 mortality and that none of the initial vaccine products have been specifically tested in pregnant people, leaving their inclusion in early vaccine rollout an open question. The unclear implications of the guidance likely means that if the ACIP recommendation is accepted by the Centers for Disease Control and Prevention, the decision will fall to individual states and health care systems to determine whether to offer pregnant health care workers the vaccine alongside their non-pregnant colleagues. FDA emergency use authorization applications for Pfizer’s and Moderna’s COVID-19 vaccine candidates are currently pending, which could lead to approval and rollout later this month.Biotech company Roche received FDA emergency use authorization for its COVID-19 antibody blood test capable of measuring the levels of specific antibodies that target the virus’ cell-unlocking spike protein. The quantitative antibody test provides a result in about 18 minutes and was shown to be very accurate in the 15 days after screening and diagnosis of an active infection with a molecular test. Studies also showed that patients’ antibody concentrations did not fall below a detectable range for at least 100 days following infection. The company has said tests of this kind will play a critical role in measuring vaccine-induced immune responses, and hopes it will help track the success of vaccines as well as identify people who have recovered from an infection and could serve as convalescent plasma donors or assist in the development of new therapies.

The ability of women to choose whether, when, and how many children to have is essential to advancing the health and well-being of women and their families. In fact, research shows that expanding global access to contraception could reduce maternal deaths by nearly one-third and child deaths by one-quarter. Yet today, 218 million women in low- and middle-income countries have an unmet need for modern contraceptives. New contraceptive innovations are urgently needed to help close this contraceptive gap, including tools that are suitable and convenient for women who live far from health care settings and multipurpose products that combine contraception with HIV prevention. In recognition of World Contraception Day, GHTC is testing our readers’ knowledge of the history of contraceptive innovation. Your challenge for each question below: Name that contraceptive method. Loading... (function(i, s, o, g, r, a, m) { var ql = document.querySelectorAll('A[quiz],DIV[quiz],A[data-quiz],DIV[data-quiz]'); if (ql) { if (ql.length) { for (var k = 0; k