Breakthroughs Blog: Maternal health

A new report launched at Davos, from the World Economic Forum and the McKinsey Health Institute, refocused the spotlight on women’s health back in January. The report found a stark gap in health between women and men, adding up to 75 million years of life lost annually due to poor health or early death. This health gap is incredibly costly—closing it would benefit 3.9 billion women and would boost the global economy by $1 trillion by 2040 due to reductions in early deaths and health conditions, as well as the greater capacity for women to make socioeconomic contributions.In recognition of International Women’s Day, GHTC is spotlighting technologies, both available and still in development, that could help close the gender health gap and move us toward gender equity by both addressing the leading causes of morbidity and mortality for women and girls and empowering them to take control of their health and future. 1. CAB-LA and the dapivirine ring for HIV preventionHIV remains a major global challenge, especially for women and girls, who account for more than half of the 37.7 million people living with HIV and 46 percent of new infections in 2022. While the introduction of oral pre-exposure prophylaxis (PrEP) has helped drive significant declines in HIV infections globally, challenges adhering to the regimen of daily pills, as well as issues of stigma, have limited its impact in certain populations, including adolescent girls and young women. Long-acting cabotegravir (CAB-LA), developed by ViiV Healthcare, is a HIV prevention option administered by injection once every two months. CAB-LA offers an option that for many is easier to consistently use and also more discreet to receive than daily oral PrEP, which can reduce a barrier to use for those who fear stigmatization if their HIV status is exposed.The dapivirine ring, developed by the nonprofit International Partnership for Microbicides, is a flexible silicone ring inserted in the vagina that slowly releases the antiretroviral medication dapivirine over one month to reduce the risk of HIV infection. The ring offers an alternative discreet, user-controlled prevention option for women at high risk of HIV who are unable or prefer not to use other prevention methods.2. HPV vaccine and self-sampling for cervical cancer prevention and treatmentCervical cancer is the fourth most common cancer in women globally, but 90 percent of deaths from cervical cancer and more than 80 percent of cases occur in low- and middle-income countries (LMICs). This is mostly due to lack of access to human papillomavirus (HPV) vaccination (nine out of every ten cases of cervical cancer are caused by persistent HPV infection) and cervical screening and treatment services. Ensuring girls and women have access to HPV vaccines and testing can help to address the persistently high burden of preventable HPV cases and cervical cancer deaths.As of 2023, there are six vaccines for HPV available globally, which all protect against the highest-risk types of HPV that cause the most cervical cancers. While there have been many studies demonstrating the safety and efficacy of HPV vaccines, a new study published in January of 2024, which was the first to monitor a national cohort of women over a significantly long period of time (the study looks at women born between 1988 and 1996), found zero cases of cervical cancer—reinforcing HPV vaccines as a lifesaving tool that has and will continue to be a game changer for women’s health. Regular screenings for cervical cancer are globally recommended and are crucial because cervical cancer can be cured if diagnosed and treated early on. Yet 67 percent of women between 20 and 70 have never been screened for cervical cancer (by HPV or other tests). HPV self-sampling, an approach recommended by the World Health Organization (WHO) for women 30 to 60, has been shown to be about as reliable as sampling by health care providers. Additionally, it has also been shown to nearly double use of cervical cancer screening services because it offers privacy and convenience, requires little time and effort, and reduces any embarrassment, pain, or anxiety that may be associated with sampling done by health workers. 3. Next-generation contraceptivesAn estimated 257 million people globally who want to avoid pregnancy are not using safe, modern methods of contraception, leading to unintended pregnancies and then unsafe abortions, which cause up to 13 percent of all maternal deaths. Unacceptable or unsuitable contraception options are one of the leading causes of unintended pregnancy. An estimated 40 percent of women in LMICs who use a contraceptive stop within a year because of challenges, including side effects, the burden of sticking to a daily regimen, and the time and monetary cost of having to travel, sometimes far distances, to get new prescriptions. Introduction of the daily oral birth control pill helped contribute to a major increase in contraceptive use globally over the past 50 years, but contraception technology has not seen major innovations in generations, and the field is deeply underfunded, highlighting the need for new, less burdensome contraceptive options.Lyndra Therapeutics is developing a once-monthly contraceptive pill, currently in preclinical development, that could serve as one such alternative. Researchers are also developing longer-acting injectable contraceptive products, including a six-month injectable contraceptive being advanced by FHI 360. Microarray patches are another novel contraceptive option in early-stage development—they work by releasing hormones over several months and are discreet and easy to use at home. Contraception, and specifically access to a variety of contraceptive options that fit varying needs, allows women and girls to have autonomy over their bodies and lives. There remains a gap in further research into nonhormonal contraceptive options that cause fewer uncomfortable side effects or contraceptives for men that take the burden off of women.4. AI-enabled ultrasoundsAlmost 800 women died from preventable causes related to pregnancy and childbirth every day in 2020. While there are many contributing factors, one significant challenge is lack of access to diagnostic tools like ultrasounds. Fifty percent of women in LMICs received no ultrasound scans during the course of their pregnancy. Even where ultrasounds are available, they are usually bulky, expensive, and require specializing training or knowledge to operate, forcing patients to travel to specific health care facilities to access them. New technologies like Philip’s Lumify Handheld Ultrasound, which can be connected to a mobile device, offer a more compact, portable option in emergency situations or in low-resource settings when traditional ultrasounds are not available or are not feasible. The Bill & Melinda Gates Foundation is funding Philips to accelerate the adoption of artificial intelligence (AI) algorithms that can be used with the scanner to simplify the identification of key pregnancy abnormalities, with results already showing that the AI-enabled technology helped to improve informed decision-making in the care of pregnant women in rural, underserved communities. Nimble, compact technologies like this ensure that more women have access to basic, lifesaving technologies and that women, along with their health care providers, can make informed decisions about their health and pregnancy, reducing the likelihood of death from preventable causes.5. Postpartum bleeding solutionsPostpartum hemorrhage (PPH), or excessive bleeding after childbirth, is the world’s leading cause of maternal death and can lead to lasting disability and psychological trauma, despite being preventable and treatable. Adolescent pregnancies carry a higher risk of postpartum hemorrhage because adolescent uteruses are not fully developed enough to sustain a healthy pregnancy—pregnancy complications, as well as unsafe abortions, are the leading cause of death among 15- to 19-year-old girls globally.PATH and Sinapi developed a technology, called the Ellavi uterine balloon tamponade, which builds on a low-cost solution some health care providers had been using to combat PPH called a “condom catheter,” which uses items commonly found and self-assembled in a clinic to insert a condom into the uterus and then fill it with water to exert pressure on the uterine walls and stop the flow of blood. The Ellavi device was optimized to be a high-quality, simple-to-manufacture and -use, and affordable version of the “condom catheter” that could be deployed globally to save even more lives. Another simple, inexpensive solution to PPH comes in the form of a plastic sheet with a pouch to collect and measure the volume of blood loss. This tool helps health care providers better recognize when women are in danger and take action. In one large-scale study in Africa, this sheet, when used in combination with other WHO-recommended treatment options for PPH, reduced the number of women experiencing severe bleeding by 60 percent and also reduced the number of deaths from PPH.These innovative but simple and low-cost technologies are not moneymakers, but they can greatly reduce preventable maternal deaths, particularly among adolescents, illustrating a paradox in women’s health—the gap persists because many technologies that could have a tremendous impact, particularly in LMICs, do not necessarily yield the greatest profit.While these five solutions highlighted have the potential to save lives and empower women, it is clear that closing the cavernous gender gap in health will require many more new tools and improved access to existing ones. Greater investment in R&D for conditions that specifically affect women and girls and expanded roles for women and girls to engage and lead across the R&D sector can help ensure more breakthroughs are realized in our lifetimes and that resulting tools are designed with the diverse needs of women and girls in mind.

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. Scientists have discovered that a naturally occurring strain of bacteria could help reduce the transmission of malaria by stopping the development of parasites in a mosquito’s gut. The bacteria, TC1, was found by chance when GSK scientists noticed that one of their mosquito colonies had stopped becoming infected with malaria parasites and later identified TC1 as the cause. Researchers have since observed that the bacteria works by secreting a small molecule, called harmane, which inhibits the parasite’s growth and that can be ingested by mosquitoes if mixed with sugar or absorbed by contact, opening the possibility for it to be used as an abatement tool. A recent study found that the bacteria can reduce a mosquito’s parasitic load by up to 73 percent, and trials in Burkina Faso are ongoing to assess the intervention’s effectiveness and safety in real-world settings.An international team of researchers has identified a genetic variant among some people of African ancestry that is associated with them having naturally lower viral loads of HIV—thereby slowing their illness progression and lowering the risk of them transmitting the virus. According to the researchers, this is the first new genetic variant related to HIV infection discovered within the last nearly 30 years. Between 4 to 13 percent of people of African origin are thought to carry this variant, which was discovered through an analysis of the DNA of almost 4,000 people of African ancestry infected with HIV-1. The scientists now intend to continue studies to more fully understand how exactly this variant impacts HIV replication.Health experts are warning that dengue poses a danger to pregnant women, as new research has found that the disease can cause serious health complications for both mothers and their unborn babies. A recent study from the University of Surrey found that mild infection can make a pregnant individual 77 percent more likely to give birth before 32 weeks and can more than double the risk of the child being born with extremely low birth weight, which can affect brain development. This work builds on prior research that found pregnant women are three to four times more likely to die after becoming infected and 450 times more likely if their infection progresses into dengue hemorrhagic fever. There are currently no specific treatments for dengue, and existing vaccines are not recommended for pregnant women.

Pregnant women in their first trimester are at risk of malaria Eileen Buxton is a Ghanaian nurse who contracted malaria while pregnant with twins. As a health care professional, she recognized the symptoms such as high fever, severe nausea, and vomiting. She sought care and was given artemether-lumefantrine, a medicine that was recently recommended by the World Health Organization (WHO) to treat malaria in the first trimester of pregnancy.Unfortunately, the situation where medicines are available and determined to be safe for use in first-trimester pregnancy is uncommon. According to the Concept Foundation, since the 1990s, only two drugs have been developed specifically for pregnant women. Furthermore, in the clinical research stage of medicine development, pregnant women, especially those in their first trimester, have been historically excluded for fear of causing harm to the mother and the baby. As a result, health care professionals and pregnant women are left with limited information, making it difficult to make informed decisions about the best course of treatment. Well-tolerated and effective antimalarials, as well as medicines for other diseases, must be developed and made available, accessible, and affordable for pregnant women like Eileen. Malaria infection and treatment during the first trimester of pregnancyMalaria, although preventable and treatable, can become fatal if left untreated, and in pregnancy, the disease has severe consequences for both the mother and the baby she is carrying. Malaria in pregnancy (MiP) can result in the severe, rather than uncomplicated, form of the disease for the mother, resulting in gestational hypertension, premature labor, miscarriage, and the fetus being small for its gestational age. Newborns can be born prematurely and with low birth weight, leading to further health complications, such as cognitive delays. During the first trimester, women are especially at risk of malaria infection because they are unprotected, as no preventive therapies are available until later in pregnancy. Data show that around 65 percent of cases of MiP appear late in the first trimester because the placenta becomes more susceptible to infection, demonstrating a clear need for recommended medicines that can both prevent and treat women in early pregnancy. Although the aforementioned effects of malaria in the second and third trimesters are well known, there has been little data collected on the effects of malaria in the first trimester: few women in malaria-endemic countries attend health facilities in early pregnancy due to a mix of cultural and logistical factors, creating an obstacle to generating research.Preventive therapies for the first trimester are urgently needed: currently, there are none. Intermittent preventive treatment of malaria in pregnancy, an intervention used in sub-Saharan Africa, is only recommended by WHO from the second trimester onward to protect pregnant women from the disease.And although WHO recently recommended the artemisinin-based combination therapy (ACT) artemether-lumefantrine for use in the first trimester, the organization’s Strategy to respond to antimalarial drug resistance in Africa also points out that most countries rely on this drug and thus recommends using a wider range of ACTs to mitigate the development of drug resistance. Ethics and regulatory frameworks for including pregnant women in clinical researchThe four main ethical principles of clinical research are beneficence, nonmaleficence, autonomy, and justice. These principles must be adhered to when designing clinical trials that safely and equitably include pregnant women in their first trimester. In fact, excluding this population perpetuates a cycle of underrepresentation in clinical research, while including them adheres to the principle of justice by ensuring that individuals, regardless of status or condition, have equal access to the benefits of medical research. Drug development takes, on average, 10 to 15 years before registration. When pregnant women are excluded from clinical research, there are no data on how well tolerated or effective it is for pregnant women when the drug reaches market. The COVID-19 pandemic demonstrated that it is possible to rapidly develop and distribute drugs, and with the Sustainable Development Goals (SDGs) set to expire in seven years, the malaria community needs to work at an accelerated pace to achieve Target 3.3 of the SDGs: end the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, water-borne diseases, and other communicable diseases. Greater priority must be placed on expediting the discovery, development, and delivery of medicines that meet the needs of at-risk groups, like pregnant women in their first trimester.Global health has experienced a paradigm shift: it is now widely acknowledged that pregnant women must be protected through, and not from, research, a principle that is underscored by recent international commitments. In 2022, at the 75th World Health Assembly, WHO member states adopted Resolution 75.8: Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. While it does not specifically mention pregnancy, this resolution provides a basis for countries in both the Global North and the Global South to develop clinical ecosystems that are “health-needs driven, evidence based, well designed and well implemented and be guided by established ethical guidance.”In 2021, the G7 Health Ministers adopted the G7 Therapeutics and Vaccines Clinical Trials Charter, which commits to “stronger collaboration in large-scale international trials to enable greater diversity of participants, including pregnant people and children” and supporting low- and middle-income countries, where malaria is most prevalent, in sustainably strengthening capacity. Malaria in pregnancy remains a major public health concern that demands urgent attention and action from global health stakeholders. Clinical research plays a critical role in advancing the development of effective interventions with an adequate safety profile. Ensuring that pregnant women are part of this research from the start can help save millions of lives and adhere to fundamental principles of justice and equity. 

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.A recent study found that an inexpensive, widely available antibiotic could sharply reduce the number of pregnant individuals in low- and middle-income countries who develop sepsis in childbirth, which is among the three leading causes of maternal deaths globally. The study, conducted in seven countries mostly in sub-Saharan Africa and Asia, showed that a single dose of the drug azithromycin during labor cut the risk of the mother developing sepsis by around 35 percent. Azithromycin is a generic drug, it has a long half-life, and it does not require refrigeration, making it an inexpensive and easy-to-deliver tool that could be widely adopted even in low-resource settings.Following the recent discovery of an outbreak of H5N1 on a Spanish mink farm, scientists have identified that the strain of the virus behind the outbreak contains a mutation that could make the virus more adaptable to mammals. While experts have stressed that there is no need panic, the outbreak is a reminder of the importance of disease surveillance and preparedness measures, especially as a new variant of H5N1 has spread among bird populations and spilled over into humans in recent years. Scientists have not detected any transmission of this latest strain among humans, although the mutation could increase the potential risk.Fungal pathogens are a growing threat to global public health, according to experts and the World Health Organization (WHO), which published a list of priority fungal pathogens last year. Resistance is exacerbating the threat. For example, Candida auris, Aspergillus fumigatus, and Cryptococcus neoformans, which WHO ranks among the four highest priority threats, have all shown resistance to current tools. There are also no vaccines for the top four critical infections identified. As aging populations and the climate crisis contribute to growing antimicrobial resistance, there is a strong need for improving surveillance capacity and investing in developing diagnostics, medicines, and other interventions for fungal infections, which currently account for less than 1.5 percent of all infectious disease research spending, according to WHO.