Lay summaries are provided below of the Research Grants given in 2024
Dr Natasha Pritchard, Prof susan Walker, Dr Emerson Keenan, Prof Stephen Tong, Dr Anthea Lindquist, and Dr Richard Hiscock
The Mercy Hospital for Women
(Sum provided $51,125)
Identifying babies that are small is a critical objective of pregnancy care. Small babies are at risk of many complications during pregnancy and birth, the most serious of which is stillbirth. A primary way of finding small babies during pregnancy is to estimate their weight using ultrasound. This weight is then plotted on a growth centile chart, which provides a percentile that compares the baby to others of the same gestational age. If the fetus is classified below the 10th centile, this acts as a key trigger to increase monitoring during pregnancy, and to offer interventions such as induction of labour or a caesarean section. The chart that is used to classify the baby’s size is therefore critically important, with substantial impacts on pregnancy care.
Unfortunately, many different growth centile charts are used within Australia. These different growth standards can lead to wildly discrepant classifications for the same infant, for example 5th centile compared to 35th centile. This means that simply performing an ultrasound at two different locations within Australia can change the centile attributed to an infant! This can alter the entire trajectory of pregnancy for the mother and baby. If the wrong chart is used, some pregnancies that are at high risk of complications will not receive the monitoring that they need. Other low-risk pregnancies could experience unnecessary interventions.
Over the past four years, the researchers have performed a series of rigorous investigations to help identify the ‘optimal’ growth standard to use in an Australian obstetric population. They have combined this research with international guidelines to come up with the key elements of an obstetric growth standard that we believe should be used. These include 1) Using a growth standard that is adjusted for the average birthweights of an Australian population (as the average birthweight in other countries can be very different), 2) Using a growth standard that compares to healthy babies still inside the mother’s womb (as babies born preterm are often smaller than average and so are not a good comparator) 3) Providing the option of a sex-specific growth standard (if the sex is known during pregnancy), as we know that male and female babies are different sizes even before birth, 4) Adjusting for each day of pregnancy, rather than each week of pregnancy, as babies can grow a lot throughout each week.
The study aims to:
1) Incorporate the elements discussed above, to create the ‘optimal’ growth standard for use in an Australian population
2) Design and publish an app that can be used on computers and smartphones, so that the growth standard can be adopted into clinical practice
3) Validate the growth centiles calculator, by applying it to a large, statewide dataset of all Victorian births over a 10-year period, and comparing it to other older obstetric growth charts
4) Audit its use in real-life ultrasound data from the Mercy Hospital for Women
Dr Shivani Pasricha, Dr Chuan Kok Lim, Dr Eloise Williams, Jacqueline Prestedge, Prof Marcus Chen, Rebecca Wigan
The Peter Doherty Institute for Infection and Immunity
(Sum provided $70,000)
Syphilis is on the rise in Australia, having increased by 358% in the past decade, indicating that current measures of outbreak control are inadequate. Caused by the sexually transmitted bacterium, Treponema pallidum, if left untreated, syphilis can cause severe morbidity, including infection of the eye, brain, and transmission from mother to baby (congenital syphilis). Since 2015, there have been increased infections amongst females and heterosexual men, disproportionately increasing amongst Aboriginal and Torres Strait Islander communities, leading to congenital syphilis re-emerging as a public health concern. Globally, syphilis causes 7.7% of all avoidable stillbirths, with congenital syphilis also causing miscarriage, premature labour, neonatal death and growth and developmental disorders in infants.
Timely and accurate diagnosis can prevent congenital syphilis, with early detection in pregnancy providing nearly 100% chance of preventing mother-to-child transmission whereas treatment of a newborn is less effective. Therefore, the best strategy to eliminate congenital syphilis is to focus on timely, accessible diagnostic methods. Syphilis testing is recommended for all pregnant women and repeat testing for people at increased risk of syphilis in pregnancy such as those with multiple sexual partners, injecting drug users and women of Aboriginal or Torres Strait Islander origin to prevent congenital syphilis. Current testing methods for syphilis and congenital syphilis rely on serological diagnosis (utilising blood samples collected intravenously from patients). This method of sample collection requires a large volume of blood collected by a trained healthcare worker (HCW) in a clinical setting which can be painful and cumbersome. Globally, poor engagement in antenatal care including missed clinic visits is a common reason why some women with syphilis during pregnancy are not diagnosed, leading to congenital infection and neonatal death. This disproportionately affects women who are socio-economically disadvantaged.
Dried blood spots (DBS) are a less invasive form of blood sampling which can be collected by pricking the finger, heel, or toe with a lancet, the blood drops are then spotted onto specially manufactured filter paper. The utility of self-collected DBS has gained traction globally as the method is easy to deploy to remote communities and outside traditional healthcare settings. DBS is commonly used for diabetes monitoring of glucose levels and as a blood collection method for infants and will be more tolerable for women requiring repeated syphilis testing throughout pregnancy due to risk factors associated with congenital syphilis. This project proposes that self-collected DBS will be an acceptable sample type for the diagnosis of syphilis infections in conjunction with existing, highly accurate, laboratory tests.
A wholistic understanding of the laboratory, clinical and patient workflows as proposed in this project provides a robust evaluation of DBS as a self-collection method for syphilis. Assessing the accuracy and feasibility of self-collected samples could lead to major advances in public health for infectious diseases and benefit a wide demographic including pregnant women in rural and remote communities. Overall, this approach would advantage our public health system in diagnosing and treating syphilis early, thus preventing congenital syphilis and other complications among pregnant women.
Dr Debjyoti Karmakar, A/Prof Fiona Brownfoot, Prof Marimuthu Palaniswami, Mr Yuchong Yao, Dr Kate Stone, Ms Dorothy McGinnes, Dr Lenore Ellett
Mercy Hospital for Women
(Sum provided $69,180)
Endometriosis, a condition impacting millions of women around the globe, often lurks in the shadows. Despite its widespread nature, getting a precise diagnosis is difficult. Many women go misdiagnosed or not diagnosed at all, leading to unnecessary suffering. Imagine waiting for an entire year, anxious and in pain, only to be given a diagnosis that might not even be right or timely. This scenario is not only distressing for the patients but also places undue stress on healthcare systems and creates a financial strain.
The vision is simple yet transformative: Utilize the power of cutting-edge Artificial intelligence (AI) to analyze ultrasound image, a common medical imaging technique, to accurately diagnose endometriosis. Instead of resorting to surgery – the current go-to gold-standard method for diagnosing endometriosis – the researchers believe AI can provide answers faster and with less physical burden on the women presenting with symptoms such as distressing pelvic pain. This could be achieved with AI. The research is targeted towards women who display symptoms that hint at endometriosis. These symptoms often manifest as relentless pelvic pain or troubles related to fertility. Traditionally, a method called laparoscopy, paired with examining tissue samples, has been the ‘gold standard’ for diagnosing this condition. This tried-and-true method serves as our benchmark, with which we will compare our AI’s performance. A team of experts has already been hard at work refining the standards we’re going to use in the AI setup.
By training their advanced deep learning algorithm on specific ultrasound images the hope is to outdo the diagnostic accuracy currently achieved by human experts. Along with their extensive research will also spotlight the most significant features in these ultrasound images and explore how different patient factors might influence the AI’s accuracy. Furthermore, by matching the AI’s results with feedback from patients and subsequent ultrasound scans, the team intend to craft a holistic understanding of the diagnosis. This approach could potentially provide enormous relief to a woman, knowing that she can get an accurate diagnosis without undergoing surgery. The researchers hope that the AI-driven diagnostic tool can quickly determine the presence of endometriosis, saving precious time, conserving medical resources, and most importantly, sparing patients from undue suffering, stress and invasive procedures. This approach also intends to describe features signifying the need for more expert surgeons to attend for surgical management of deeper/more advanced endometriosis, thus avoiding incomplete treatment and surgical complications.
Dr Elizabeth Baker, Dr Kari Holte, Prof Claus Klingenberg, Dr Rebecca Szabo, Ms Tatiana Zecher, Prof Peter Davis, A/Prof Marta Thio
Royal Women’s Hospital
(Sum provided $55,048)
This study, titled ‘A validation study of a new dry-electrode ECG device for preterm infants’ aims to evaluate a new method of monitoring the heart rate of a preterm baby (born between 26- and 31-weeks’ gestation) immediately after birth. The study will compare current gold standard tests with the ‘NeoBeat MiniTM’, a reusable and consumable-free heart rate monitor that simply and quickly wraps around baby’s chest.
Preterm babies often require lifesaving support in the first minutes of life as they adapt to conditions outside the womb. The need for resuscitation and response to these lifesaving interventions are guided by the newborn’s heart rate. A low heart rate at five minutes is associated with a four-fold increase in risk of death for babies born at less than 32 weeks’ gestation.
A rapid and reliable method of measuring the newborn’s heart rate is critical. However, standard heart rate monitoring methods have limitations, including a delay in detecting heart rate, challenges in application during resuscitation, and availability in low resourced settings.
The NeoBeat Mini, a new therapeutic goods administration approved device, adapts existing electrocardiogram (ECG) technology into a small portable device that is quick and easy to apply around a preterm baby’s abdomen. Though approved for use, the device has not been validated in clinical settings. The Royal Women’s Hospital, and its international collaborators, aim to test if the NeoBeat Mini, compared with existing methods, accurately and quickly measures a preterm baby’s heart rate.
If accurate, the NeoBeat Mini may provide many advantages over current methods of heart rate monitoring, and aid clinicians in those first minutes after a baby is born to provide critical life-saving care.
A/Prof Atul Malhotra and Prof Ben W. Mol
(Sum provided $70,000)
Preterm birth occurs when a baby is born before 37 weeks of pregnancy. It occurs in approximately 9% of Australian pregnancies, and is in quantity and severity the most important issue in obstetric care in Australia and worldwide. Prevention of preterm delivery is therefore a major perinatal research priority.
During the COVID-19 pandemic, it had been unexpectedly observed that there was an association between COVID-19 mitigation measures (community lockdowns in particular) and rates of preterm birth. At Monash Health, the largest maternity provider in Victoria, the team observed during stage 3 and stage 4 lockdowns (in 2020), with significant restriction of movement and human social contact, a 30% reduction in both spontaneous and medically indicated preterm birth, and a delay in delivery for those who still deliver preterm. Hypotheses on the mechanism include reduced rates of infection due to other viruses and pathogens, and reduced movement outside the home setting. In a more detailed analysis, we reported that this effect of mitigation measures during lockdown is strongest in women with previous preterm birth. The researchers have also found that the effect mainly occurs due to less spontaneous preterm labour in these women.
Our observations during the pandemic in combination with our team’s track record in the prevention and treatment of preterm birth provide a unique opportunity to further study this phenomenon. We now need to translate these observations into interventions that could potentially help women at risk of preterm birth. In this project, the team propose an innovative, randomised clinical trial in which they will evaluate whether an intervention in pregnancy mimicking COVID-19 infection transmission mitigation measures will reduce preterm birth rates in pregnant women with previous preterm birth.
The researchers have designed a trial for a pregnancy intervention based on COVID-19 mitigation measures. Described in detail in the proposal, it will contain advice for reduced activity, less social contacts, hand washing, and wearing a facemask when in public. In short, they will randomise 100 women with previous preterm birth (the highest risk group) for a 6-week intervention or care without restrictions as usual. Primary outcome will be delivery before 34 weeks.
This pilot feasibility project will evaluate whether this pregnancy intervention for women at high risk of preterm birth is feasible, and whether it has the potential to result in an improved preterm birth outcome for these women. Their very strong track record in research in preterm birth and in clinical trials provide, in combination with this unique finding of reduced preterm birth, and enormous opportunity in the battle to reduce preterm birth in Australia and globally.
Dr Samantha Mooney, Dr Vanessa Ross, A/Prof Martin Healey, A/Prof Ricardo Palma-Dias, Dr Debbie Nisbet, Dr Sofie Piessens, Dr Kate Stone, Dr Tristan McCaughey, Dr Clair Shadbolt, Dr Natalie Yang, Dr Stephen Esler, Dr Marsali Newman, Dr David O’Keefe, Prof Peter Rogers
Mercy Hospital for Women
(Sum provided $25,015)
Adenomyosis is a condition where the lining cells of the uterus (the ‘endometrium’) are present within the muscular layer. This results in thickening and potential scarring of the muscular layer of the uterus. In recent studies, adenomyosis has been associated with an increased risk of troubles becoming pregnant, and complications during a pregnancy. However, there is very little evidence explaining why adenomyosis may be associated with these complications, including miscarriage, preterm birth, and high blood pressure conditions in pregnancy. A further complication reported to be associated with uterine adenomyosis is placenta accreta spectrum (PAS), where the placenta attaches too deeply to the uterine wall.
As a foundation for investigation of the links between adenomyosis and pregnancy outcomes we plan to perform a suite of descriptive studies.
1. A prospective observational study will be performed where high quality ultrasound techniques will be used to observe the appearance of the uterine muscle in patients with adenomyosis who become pregnant. Patients will be invited to participate if they attend for an early pregnancy ultrasound and have previously had a non-pregnant ultrasound demonstrating features that are strongly suggestive of adenomyosis. Participants will then undergo an additional ultrasound 6months postpartum, to again assess the uterine muscle for features of adenomyosis.
2. A retrospective cohort study across two major obstetric hospitals in Melbourne will be conducted. A common indication for MRI in pregnancy is for the investigation of abnormal placenta, eg PAS. It is hypothesized that patients with PAS have an increased likelihood of adenomyosis on their pregnancy MRI. Patients who have previously undergone MRI in pregnancy and been diagnosed with PAS will have their MRIs reviewed, with specific mention of features that suggest adenomyosis. This will be an observational study reporting the ability to see features of adenomyosis in pregnant patients undergoing MRI in pregnancy for investigation of PAS. In this same cohort, some patients will have undergone caesarean section with hysterectomy (as is often required treatment for PAS). The histology of this subgroup will be reviewed to describe the prevalence of adenomyosis in this cohort. Similarly, many of this cohort will have had a pre-pregnancy and/or early pregnancy ultrasound at one of the two study centres. The images of this subgroup will be retrospectively reviewed by one of the study experts, and categorized according to the presence of certain features of adenomyosis.
Dr Natasha de Alwis, Professor Natalie Hannan, Dr Natalie Binder, Dr Alina Roman
The University of Melbourne
(Sum provided $69,964)
Preeclampsia is a serious and deadly complication of pregnancy, taking the lives of over half a million babies and 70,000 mothers every single year. In pregnancies complicated by preeclampsia, poor oxygen supply causes the placenta to be in a state of stress, which initiates the prolonged release of toxic inflammatory and damaging factors into the maternal circulation. These toxins spread throughout the body causing major injury to the mother’s blood vessels and major organs, especially the cardiovascular system. As such, preeclampsia is a leading cause of maternal and neonatal death and long-term disability worldwide, with disease burden being highest in developing nations where obstetric and neonatal care is not readily accessible. Unfortunately, there is no effective treatment for preeclampsia; current clinical practice is to prematurely deliver the placenta and baby to save the mother. Urgent development of therapies for preeclampsia is desperately needed.
In this study, the researchers will investigate the potential of the anti-inflammatory medication, infliximab to treat preeclampsia. Infliximab works by inhibiting the action of a key toxic inflammatory mediator, tumor necrosis factor (TNF). It is commonly used in the clinical treatment of chronic inflammatory conditions such as rheumatoid arthritis and inflammatory bowel disease. TNF is elevated in preeclampsia and directly contributes to the inflammatory environment of this insidious disease, making TNF an excellent target for treatment.
Specifically, they investigate the potential of repurposing TNF inhibitor infliximab to treat preeclampsia in their laboratory models of human pregnancy. They will assess whether infliximab can reduce injury to the placenta and blood vessels, and closely examine the passage of infliximab through the placenta to the fetus. This study will uncover whether blocking these toxic factors released from the stressed placenta might be an effective way to treat preeclampsia.
Importantly, infliximab is currently used clinically in pregnant women with underlying inflammatory conditions, and is generally considered safe for use in pregnancy. Thus, they envisage expedited translation of our findings into human clinical trials in pregnant women. Concurrent to this project, the team and clinical collaborators will be performing small clinical cohort studies to investigate the action of infliximab in cohorts of pregnant women at risk of/or diagnosed with preeclampsia.
Together, this pre-clinical laboratory and clinical trials data will provide key information regarding the safety and efficacy of infliximab to treat preeclampsia. The team would then initiate a large-scale international clinical trial to validate the effectiveness of these drugs in different pregnant cohorts. If successfully translated, infliximab could be an exceptional first step towards treating a pregnancy complication that has existed for millennia but has never had an effective treatment – potentially saving hundreds of thousands of lives every year and preventing long-term injury in many more.
Dr Scott Stansfield, Dr Carmel Walsh, A/Prof Kirsten Palmer, A/Prof Samuel Forster, Prof Marcel Nold
(Sum provided $66,567)
Chorioamnionitis affects 1-4% of all pregnancies. It is a serious pregnancy condition in which the placenta and membranes surrounding the unborn baby become inflamed, usually as the result of bacterial infection. It is a major contributor to preterm birth; approximately one-third of births before 34 weeks are associated with chorioamnionitis (in Australia, this equates to over 2,700 babies a year). For these newborns, in addition to the significant sequelae of prematurity, there is the risk of significant complications including infection in the blood, pneumonia, severe lung disease, and inflammation of the brain and spinal cord. Chorioamnionitis is also a risk to the mother, as it may result in significant illness with fevers, tachycardia, and pain. If unrecognised or untreated, it may lead to sepsis – a potentially life-threatening condition.
The risk of chorioamnionitis is increased in pregnancies with predisposing complications, including preterm prelabour rupture of membranes, recurrent bleeding, and short cervix. Although these risk factors are well defined, there is currently no readily available test to confirm the diagnosis of chorioamnionitis. Instead, the diagnosis is clinically determined by assessment of a myriad of markers or waiting for overt chorioamnionitis to manifest. This carries great risk of sepsis for the mother and child. In addition to the challenge of accurately establishing a diagnosis, antibiotics (which are the mainstay of treatment), do not cross the placenta well or penetrate the fetal membranes, resulting in inadequate treatment and ongoing risk to the unborn baby.
Consequently, the diagnosis of chorioamnionitis always leads to expediting birth, to ensure the optimal antibiotic treatment for both mother and newborn. Studies of the placenta and membranes of preterm babies reveal the presence of chorioamnionitis even in the absence of clinical signs. This is known as subclinical chorioamnionitis. This is a significant concern for clinicians, as our research has shown that preterm babies born in the setting of subclinical chorioamnionitis demonstrate inflammatory changes that pre-dispose them to severe lung disease. Unfortunately, there is no current method to assess the degree of inflammation in the unborn baby, or to accurately detect subclinical chorioamnionitis. As a result, clinicians face the conundrum of either waiting until clinical signs of chorioamnionitis develop, despite knowing that undetected chorioamnionitis increases the risk to the newborn, versus early delivery, whereby preterm birth in the absence of these inflammatory processes also carries the risks of prematurity to the newborn resulting in unintended harm.
This project aims to identify biomarkers that enable the early identification and staging of chorioamnionitis to better inform timing of birth decisions. The researchers plan to use innovative minimally invasive techniques to assess pregnant women at high risk of chorioamnionitis, and correlate these with histopathology findings of the placenta and membranes, and with the clinical outcome for mothers and babies. The potential significance of this work is profound – accurate diagnosis of chorioamnionitis will allow clinicians to reduce the risk of severe infections for mothers and babies and prevent unintended harm of prematurity that arises when clinicians get the diagnosis wrong or due to subclinical chorioamnionitis.
Melvin Marzan, A/Prof Lisa Hui, Prof Andrew Wilson, Karrie Long, Prof Mark Umstad, Dr Jake Valentine
The Mercy Hospital to Women
(Sum provided $69,080)
Childbirth is a profound life experience for families. Yet, it’s not without its challenges from both personal and societal perspectives. Our project is dedicated to making this journey safer for mothers and babies and cost-effective for the Victorian Health Care System. One of the most dramatic and sustained impacts of the COVID-19 pandemic is the reduction in hospital length of stay for both mothers and newborns. No Victorian study has yet explored the potential health and economic tradeoffs from the shortened length of stay. Our recent work with Safer Care Victoria has exposed unintended consequences of shorter length of stay, including an increase in unplanned readmissions of newborns for feeding problems and suspected infections. An unplanned hospital admission is hugely disruptive for young families as well as costly for the health system.
This project proposes to harness the power of big data, predictive analytics, and machine learning, to transform the way care for new mothers and babies by providing personalized risk assessment of unplanned readmissions. This will enable to identify those who might benefit from additional support, for example, through inpatient services, domiciliary midwife care, or community health services.
To make this happen, the team will tap into the richness of healthcare information contained in the statewide maternity data collections. These records will be linked to hospital and emergency admission datasets, medical benefits schedule (MBS) and pharmaceutical benefit schemes (PBS) datasets. The data will be teamed up with advanced epidemiological and statistical modelling and machine learning. By supplying the models with data from thousands of birth records, hospital readmission records, healthcare utilization through the PBS and MBS schedules, computers can be trained to predict if a mother or baby might need extra medical attention in the year after birth.
Machine learning can apply its computational power to routinely collected datasets to achieve better care for mothers, babies, and families. If the team can predict unplanned readmissions, they can step in with the right care, at the right time, for the right patient. This could prevent unnecessary trips to the hospital, save time, money, and most importantly, ensure better health outcomes for young families. The project’s envisions a Victorian healthcare system that doesn’t just wait for problems to happen, but actively prevents them. This means better healthcare decisions, resources used wisely, and happier families as emphasized in the “Targeting zero program” of the State Government of Victoria. It’s about giving families peace of mind, knowing that the best care is there when they need it.
Dr Shiraz Badurdeen, Prof Peter Davis, A/Prof Susan Donath, A/Prof Margarita Moreno-Betancur, Ms Kate Francis, Prof Jeanie Cheong, A/Prof Sue Jacobs, A/Prof Hamish Graham, Prof Stuart Hooper, Prof Graeme Polglase,
Collaborators contributing data- Prof Helen Liley (Aus), Dr Rakesh Rao (USA)
Murdoch Children’s Research Institute
(Sum provided $52,421)
Birth asphyxia is the result of a critical shortage of oxygen supplying the brain before and during birth. Despite improvements in obstetric care, birth asphyxia affects 3 in every 1000 births in Australia and over 1 million births per year worldwide. Damage to the baby’s brain from birth asphyxia leads to a condition called hypoxic-ischaemic encephalopathy (HIE). HIE is a leading cause of childhood death and lifelong disability, including cerebral palsy, epilepsy and intellectual difficulties. Despite the enormous health and economic burden, there have been no new treatments for HIE over the last decade.
Oxygen is the most commonly used drug during newborn resuscitation. Too little oxygen is harmful but the latest research in the laboratory found that following resuscitation, the baby’s brain is extremely vulnerable to receiving too much oxygen. Excessive oxygen damages the brain’s mitochondria, which are the cell’s powerhouse. This triggers the key pathways responsible for additional brain injury that typically follows the initial injury at birth from asphyxia. Based on these laboratory discoveries, the team looked at their own historical data of babies with HIE. The preliminary findings showed that high oxygen levels within 2 hours of birth increased the chances of death or disability at 2 years of age.
The aim to confirm the findings in a world-first study, creating a large, combined dataset of babies with HIE. Latest statistical methods will be applied to analyse data from babies who participated in 4 international research studies over the last 10 years. In line with ethical recommendations, the team will be making best use of existing high-quality, consistently measured data that research participants have already provided.
Specifically, the aim is to examine whether early exposure to high oxygen levels (measured using a blood test within 2 hours after birth) increases the risk of death or disability (measured at 2 years of age) in babies born at ≥35 weeks’ gestation with moderate-to-severe HIE. To achieve this, the researchers will combine the expertise of our diverse team of statisticians, clinicians, and scientists. Individual data from approximately 1300 babies from research studies in the USA and Australia will be collated. The combined dataset will be analysed using cutting-edge “causal inference” statistical methods. These methods are essential to accurately answer the question because they adjust for biases that distort the true cause-and-effect relationship between high oxygen exposure and death/disability. Therefore, the team will able to find out whether avoiding excess oxygen in babies with HIE could reduce the risk of death and disability.
This research may open a new avenue of treatment for babies with HIE, for whom the chances of a poor outcome remain unacceptably high. Unlike new drugs or devices, the implementation of our findings to clinical care will be quick. Getting oxygen right will become a priority in the care of these vulnerably babies, both in Victoria and around the world.
Prof. Jayashri Kulkarni AM, Dr Eveline Mu, Dr Qi Li, Mr Anthony de Castella
(Sum provided $70,000)
Major depression in women during their childbearing years is extremely common, and has an associated high morbidity and mortality. As a result, the use of antidepressant medications during pregnancy is widespread. Making decisions about using antidepressants during pregnancy can be difficult. We need to balance helping the mother’s mental health with ensuring the developing baby’s well-being. While antidepressant use in pregnancy may be considered a risk to the health of the developing infant, stopping treatment also carries the risk of harm to the mother including severe maternal depression relapse, and at times suicidality. However, recent evidence suggests that the risk of antidepressant intake during pregnancy for the baby are small or non-existent, and the risk of poor maternal and baby outcomes are small to medium (1). This information is misleading and concerning as these studies do not give us a clear indication of the long-term effects. Our study aims to change that by tracking mothers throughout their pregnancy and their children for three years after antidepressant use during pregnancy.
Why this study matters
Many studies look at short-term outcomes, but we are missing the bigger picture. Our study will help us understand the lasting effects of antidepressant use during pregnancy. By following mothers and children for three years, we can see how these medications impact the child as they grow.
What we will do
We will work with pregnant women who are taking antidepressants compared to those who are not. We will follow both groups during pregnancy to three years after childbirth. We will measure the children’s development, behaviour, and how they learn. We will also check how mothers are doing mentally. We believe three years is a good amount of time to see how things are going. We will be able to track any developmental differences and identify issues that may appear later on.
The results of our study will inform women and their doctors about the safety of antidepressants in pregnancy. Our results will provide evidence-based advice about pregnant women who need antidepressants. We aim to better understand the impact of medication taken during pregnancy on the development of the baby. We aim to provide this information to health practitioners and the general public. In particular, we want to empower women to collaboratively make informed decisions, with their doctors about the safest treatment for them and their babies. Our findings will be used to create guidelines for treating pregnant women, and policymakers can use our findings to shape regulations about using antidepressants during pregnancy.
Professor Claudia Nold, Dr Marcel Nold, Dr Ina Rudloff, Dr Steven Cho, Dr Ramesh Nataraja, Dr Maurizio Pacilli
(Sum provided $69,950)
In Australia, up to 11% of babies are born prematurely and approximately 3,000 infants (1.6%) are born very preterm (prior to 32 weeks’ gestation). While medical advances have significantly improved their survival, sadly, these babies are at risk of diseases of prematurity such as necrotizing enterocolitis (NEC). NEC is a devastating disease in which parts of the baby’s gut become increasingly inflamed and porous, and ultimately die.
Early clinical symptoms of NEC are non-specific, making an early diagnosis difficult. Once NEC can be diagnosed with certainty, affected infants are often in an advanced disease state with disastrous damage to their gut that can lead to serious complications and death within hours. With a mortality rate of up to 65%, NEC is one of the most common causes of death in extremely premature infants between 15-60 days of life. Those who survive often face long-term consequences such as disability, epilepsy and poor growth. Currently, clinicians cannot predict which babies are at risk of developing NEC and unfortunately, once the disease is diagnosed there are no direct, safe and effective treatments available. Moreover, measures considered to lower a baby’s risk of developing the disease (such as breast- instead of formula-feeding) or that support healing of the gut (including bowel rest [i.e. intravenous administration of nutrition instead of oral feeding] and antibiotics to eradicate pathologic gut bacteria that might contribute to NEC) are largely ineffective once the disease is in an advanced stage.
Since 2012, the team has worked on advancing knowledge in this field, aiming to develop new diagnostic and therapeutic strategies. The researchers have started to collect and safely store blood samples from preterm babies at different time points (including days 1, 7, 14, 21 and 42 of life and day of discharge from hospital) and recorded their clinical data. While some of these babies developed normally without any diseases of prematurity, others were later diagnosed with NEC. For the study proposed here, samples from day 1 and day 7 of life (i.e. before any of the babies had NEC) will be subjected to cutting-edge tests that screen for the presence and abundance of blood protein markers at a scale never seen before (i.e. 7000 markers per sample) in the very low blood volumes (~0.5ml) available from preterm babies for research purposes. The comprehensive data generated by this test will be used to identify differences in the blood of babies that later developed NEC compared to those that did not, laying the foundation for the identification of the very first biomarkers for NEC, detectable in the babies’ blood before they get sick. Such biomarkers would be invaluable as in the future they could be used to easily screen all preterm babies by performing a simple blood test, informing clinicians whether or not babies are at risk of developing the disease. Simple changes in the care of those babies could potentially prevent the disease, ultimately making a real difference to the lives of our tiniest patients and their families in Australia and worldwide.
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