Protecting Pregnant Women in Clinical Research

Excited to share our newly published paper - “IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy.” Despite the remarkable success of direct-acting antivirals (DAAs) in curing hepatitis C, pregnant women have largely remained outside the evidence base needed to guide treatment during pregnancy, leaving an important gap precisely when opportunities exist to improve maternal health and potentially prevent perinatal transmission. IMPAACT 2041 was designed to help change that. This multicenter Phase I/II trial evaluates the pharmacokinetics and safety of glecaprevir/pibrentasvir initiated during pregnancy in women with HCV, including those with HIV coinfection. In this paper, we describe the scientific evidence and deliberate process that shaped the study’s design. Generating rigorous therapeutic evidence in pregnancy should not be an afterthought. It is essential to ensuring that pregnant women can benefit from the same advances in medicine available to everyone else. Grateful to the entire IMPAACT 2041 team and our collaborators for helping move this important work forward. The Society for Maternal-Fetal Medicine American Society for Clinical Pharmacology & Therapeutics American College of Obstetricians and Gynecologists (ACOG) Royal College of Obstetricians and Gynaecologists | RCOG Royal Australian and New Zealand College of Obstetricians and Gynaecologists RANZCOG #HepatitisC #ClinicalTrials #MaternalHealth #ClinicalResearch #GlobalHealth #InfectiousDiseases #WomensHealth #JohnsHopkins #Harvard https://lnkd.in/eZE696YQ

The impact of hemophilia in women and girls remains insufficiently recognized, contributing to delayed diagnosis, under-evaluation of bleeding symptoms and missed opportunities for appropriate management. New guidance from the ISTH Scientific and Standardization Committee (SSC), now published in Journal of Thrombosis and Haemostasis (JTH), provides recommendations to help standardize the screening and diagnosis of hemophilia carriers and women and girls with hemophilia. Developed collaboratively across the ISTH SSC Subcommittees on Pediatric and Neonatal Thrombosis and Haemostasis; Factor VIII, Factor IX and Rare Coagulation Disorders; and Women’s Health Issues in Thrombosis and Haemostasis, the guidance addresses: ➡️Nomenclature and classification ➡️Use of the ISTH-Bleeding Assessment Tool to quantify bleeding phenotype ➡️FVIII and FIX assays and assay discrepancies ➡️Genetic testing ➡️Testing during pregnancy and postpartum By supporting more consistent screening and diagnosis globally, this guidance represents an important step toward improving management and advancing gender equity in hemophilia care. 📖 Read the full guidance in JTH: https://lnkd.in/gZqBbsCN 

Anaemia in pregnancy is common in Ghana, and haemoglobin variants are too. What we didn't know was how much the variant itself explains the red cell picture — and how much is just pregnancy. Our study of 400 pregnant women attending antenatal care at Ga West Municipal Hospital is now published in BioMed Research International. What we found: → Women with HbS/HbC/HbSC phenotypes had lower haematocrit and MCV than those with HbA, with heterozygous carriers (HbAS/AC) falling in between — a gradient rather than a cut-off. → After adjustment, gestational trimester rather than phenotype was the dominant correlate of anaemia. The variant matters for the red cell indices; the stage of pregnancy matters more for whether a woman is anaemic. → Only 6 women carried an HbS/HbC/HbSC phenotype, so those estimates are imprecise, and we say so in the paper. HbC-containing phenotypes were presumptive on electrophoresis rather than confirmed by HPLC. The practical read: haemoglobin phenotype is useful context when interpreting a full blood count in pregnancy, but it shouldn't distract from trimester-specific anaemia screening and management. Open access — full tables and supplementary data included: https://lnkd.in/dDPZB7Pz Grateful to my co-authors, to the staff at Ga West Municipal Hospital, and above all to the women who agreed to take part. #Haematology #SickleCell #MaternalHealth #GlobalHealth #OpenAccess

Pregnant and breastfeeding women have long been underrepresented in clinical research, leaving important gaps in the evidence needed to guide their care. A new publication in the Journal of Translational Medicine highlights the importance of putting ICH E21 - guidelines on including pregnant and breastfeeding individuals in clinical trials - into practice.  Developed by the Collaborative Group on Global Maternal and Child Health, the publication brings together 10 organizations to highlight what is needed to move from guidance to action. This includes ensuring that exclusion only occurs where there is robust scientific justification, strengthening benefit–risk assessments that consider both treatment and non-treatment, and reinforcing ethical and safety frameworks. It also means generating the evidence needed to guide inclusion across pregnancy, postpartum and breastfeeding. We are proud to contribute to this collaborative effort. ICH E21 is an important step forward, but its impact will depend on how effectively it is put into practice so that pregnant and breastfeeding women and their infant are not left behind in the evidence needed to inform safe and effective treatment. 📖 Read the publication: https://lnkd.in/dZAF-9cq #MaternalHealth #ClinicalResearch #GenderResponsiveRD #ResearchInclusion #GlobalHealth     Craig Tipple | Shikha Taneja Malik | Fabienne Benoist | Medicines for Malaria Venture | International Vaccine Institute (IVI) | Liverpool School of Tropical Medicine | มหาวิทยาลัยมหิดล | TB Alliance | Concept Foundation (non-profit) | Global Antibiotic R&D Partnership (GARDP) | FIND | Makerere University | University of Liverpool | BMC | Springer Nature

A new case report from DRC highlights how a ruptured ectopic pregnancy became life-threatening emergency in an Ebola Treatment Unit with limited diagnostic and surgical capacity. ETUs need the capacity to rapidly diagnose and manage obstetric and other life-threatening emergencies. Authors: Prince Imani-Musimwa, Emilie Grant, Daniel Mukadi-Bamuleka, Rigobert Fraterne Muhayangabo, Alfred Ombeni, PhD, Zacharie Tsongo Kibendelwa, Olivier Nyakio-Ngeleza, Richard Kitenge-Omasumbu, Théophile Barhwamire-Kabesha, Dieudonné Sengey-Mushengezi-Amani, PLACIDE MBALA, Richard Bitwe-Mihanda, Juakali Sihali-Kyolov, Mija Ververs   https://lnkd.in/eaJ6BgGm

Expanding Sickle Cell Care Can Help More Children Thrive. Sickle cell disease is not only a health condition it is a lifelong challenge that can affect a child's health, development, education, and quality of life. The World Health Organization is taking steps to expand access to lifesaving sickle cell treatment and care for children, including efforts to improve access to quality-assured, affordable and child-friendly medicines. This is particularly important in sub-Saharan Africa, where a large proportion of children affected by sickle cell disease live. This reminds us that improving child health requires more than having effective treatments available. Children and families also need early diagnosis, reliable health information, access to appropriate care, and continued support throughout the course of the condition. When families are empowered with accurate information and children can access timely, evidence-based care, we can reduce preventable complications and give more children the opportunity to live healthier lives. At Lady Helen Child Health Foundation, we believe that protecting a child's future begins with accessible and quality healthcare from the earliest stages of life. Through child health advocacy, nutrition education, parental education, research, and promotion of evidence-based healthcare practices, we are committed to supporting healthier children and empowering families with reliable health information. By strengthening awareness and improving access to appropriate care, we can help ensure that children living with sickle cell disease are given the opportunity to grow, develop, learn, and thrive. Follow Lady Helen Child Health Foundation for more updates on maternal and child health advocacy. https://lnkd.in/dYc6TsZ Source: World Health Organization (WHO) https://lnkd.in/dEYu-RJ6

820,000 Children a Year Could Be Saved by a Standard That's Already 1,400 Years Old Fourteen centuries before a Missouri jury awarded $495 million over a formula linked to a bowel disease in premature infants, the Qur'an had already set the standard those infants were missing: "The mothers shall breastfeed their children for two complete years, for whoever wishes to complete the nursing period" [Qur'an 2:233]. The WHO's current recommendation—exclusive breastfeeding for six months, continued to two years and beyond—echoes the same number modern epidemiology eventually arrived at independently. Put the two feeding methods side by side on the exact disease at the center of the Abbott litigation. Maternal milk fed infants developed necrotizing enterocolitis at a rate of 1.6%. Formula fed infants in the same study: 13%—a 6 to 10 times higher risk, replicated across multiple cohorts—not a single outlier trial. That's not a marginal difference. That's the disease the lawsuit is about—at rates that track almost exactly with which feeding method was used. Extend the comparison past NEC. Breastfeeding cuts SIDS risk by 36%, diarrhea incidence and mortality by 56%, obesity risk by up to 30%, celiac disease risk by over half when breastfed at the time of gluten introduction and carries measurable gains in IQ and reduced ADHD risk. Think about the accountability of the parents—the mother in particular—as it relates to health, not just as a child, but later in life. And yes, it protects the mother too: fewer maternal deaths from breast cancer, among other outcomes. Scale it globally and the number gets almost hard to process: near-universal adherence to breastfeeding guidelines would save over 820,000 children's lives a year and roughly $300 billion annually, according to the Lancet's own breastfeeding series. And that same research also names the obstacle: aggressive marketing of breast-milk substitutes remains, in its own words, "a substantial global barrier to breastfeeding." It gets more uncomfortable... None of this makes formula forbidden per se. In fact, Islam never pretended otherwise. Rather, the same verse that commands two years also permits mutual consultation and alternatives when breastfeeding genuinely isn't possible. Real medical need exists—preterm infants with no other option exist. Sensible. The onus this piece is actually pointing at doesn't just land only on companies like Abbott but the culture we've created—Muslim households included—that's normalized formula as the equivalent and convenient instead of the fallback it was suppose to be, while an industry with every financial incentive to keep that normalization intact spends heavily to make sure it stays that way. The lawsuit will get litigated on causation. Islam settled the actual standard a long time before anyone needed a jury to find it. #Breastfeeding #PublicHealth #IslamicEthics #MaternalHealth #Parenting #Milk #FormulaMilk #Feeding #Diseases #Children #BabyDiseases

I’m very happy to share our new publication in JAMA Network Open: “Inhaled Corticosteroids Continuation in the First Trimester and Pregnancy Outcomes in Women With Asthma.” Asthma management during pregnancy can be challenging, particularly when concerns about medication safety lead women to discontinue treatment. In this cohort study using the Korean nationwide healthcare database (NHID), we examined whether continuing inhaled corticosteroids (ICS) during the first trimester was associated with maternal and neonatal outcomes. Among 6,105 pregnancies with prepregnancy ICS use, only 34.5% continued ICS during the first trimester. After accounting for differences between treatment groups, continued ICS use was not associated with an increased risk of major maternal or neonatal outcomes. These findings provide reassuring evidence supporting the continuation of ICS when clinically indicated to maintain asthma control. This project is particularly meaningful to me because I had the opportunity to work as a co-first author with Bohyun Suh, whom I was fortunate to mentor as a senior student. Seeing a project develop through collaboration and mentorship has been one of the most rewarding parts of this work. I’m also very grateful to our corresponding authors, Yunha Noh and Judy Shin, for their guidance throughout the project, as well as to all of our collaborators who contributed their expertise. Link to the study: https://lnkd.in/giS4y4Up

Innovative research is underway at Aberystwyth University to develop home-based lateral flow tests for early detection of breast cancer, endometriosis, and PCOS. These tests, using urine samples, show high accuracy in identifying changes indicative of breast cancer. The goal is to have a prototype within a year, enabling at-home testing or easier GP consultations. This effort is part of a significant Welsh Government investment in women's health research. The initiative aims to bridge the gap between research and clinical practice, which currently averages 17 years. A ten-year Women's Health Plan is set to establish dedicated health hubs across Wales, offering tailored community services. Efforts are also being made to train local GPs in specialized areas like menopause and contraception to improve access and reduce wait times for conditions such as pelvic pain and endometriosis. #WomensHealth #MedicalResearch #HealthcareInnovation #EarlyDetection #Wales

HHS Announces $4 Million Initiative to Expand Rapid Syphilis Testing & Treatment to Protect Mothers and Babies WASHINGTON, D.C.—AUGUST 12, 2026 The U.S. Department of Health and Human Services (HHS) today announced a $4 million initiative to expand access to rapid, point-of-care syphilis testing, with a focus on reaching women in emergency departments and other nontraditional healthcare settings. “Congenital syphilis is preventable, yet too many mothers and babies are still suffering its devastating consequences,” said HHS Secretary Robert F. Kennedy Jr. “HHS is putting rapid tests where women receive care so we can detect infections earlier, treat them faster, and protect more babies.” Congenital syphilis cases have risen for 12 consecutive years, with nearly 4,000 cases reported in 2024 — a nearly 700% increase over the past decade. In 2023, congenital syphilis contributed to 279 stillbirths and infant deaths. An estimated 83% of congenital syphilis cases that year could have been prevented with timely testing and treatment. Syphilis during pregnancy can cause miscarriage, stillbirth, infant death, and lifelong medical complications. Yet more than 40% of pregnant women who delivered a baby with congenital syphilis in 2023 did not receive a syphilis test in time to receive adequate treatment before delivery. Point-of-care syphilis tests can provide rapid results, allowing healthcare providers to begin treatment immediately rather than waiting for traditional laboratory testing. Expanding access to these tests can help close gaps in care, particularly for women who may not regularly receive care in traditional clinical settings. Through the new initiative, HHS is directing funding to the Centers for Disease Control and Prevention’s Division of STD Prevention to increase access to point-of-care testing and treatment. HHS is providing approximately $3.25 million in supplemental awards to recipients of CDC’s Strengthening STD Prevention and Control for Health Departments cooperative agreement (PS19-1901) to expand access to syphilis point-of-care testing and link patients to care from August 2026 through February 2027. Awarded jurisdictions have been identified as experiencing a high burden of syphilis and congenital syphilis. Remaining funding will support national partners providing technical assistance and implementation support. The initiative will promote syphilis screening and treatment beyond traditional healthcare settings and strengthen partnerships across public health programs. Emergency departments, maternal and child health programs, correctional intake settings, substance use treatment programs, and other settings can provide additional opportunities to identify and treat syphilis, including during pregnancy. By expanding rapid testing and strengthening collaboration across sectors, HHS aims to reduce missed opportunities for diagnosis and treatment, prevent congenital syphilis, and improve health outcomes for mothers and babies.