Title Promoter Affiliations Abstract "Long-term WIFS and malaria risks in early pregnancy : a randomised controlled trial" "Sabine Desager, D'Alessandro" "Institute of Tropical Medicine" "Overall objective To assess the safety and efficacy of weekly iron and folic acid supplementation (WIFS) in young women of child-bearing age living in a highly malarious area in Africa. Primary objective To assess the impact of long-term weekly iron supplementation in young women of child-bearing age on P.falciparum malaria infection during early pregnancy. Secondary objectives 1. To assess the impact of weekly iron supplementation on: ? incidence of clinical malaria prior to and in early pregnancy. ? iron deficiency and anaemia prevalence prior to and during early pregnancy. ? on pregnancy outcomes (miscarriage, stillbirth, preterm delivery, birth weight). 2. To explore the acceptability of long-term WIFS in young women. Number of subjects The required number of pregnant women in each group will be 390. Allowing for loss to follow-up, we expect this number of pregnancies to occur in a total study population of 1800 non-pregnant, nulliparous women aged 15-24 years over a period of 18 months." "Improving the quality of care in early pregnancy: the added value of medical imaging, 3D-mapping and translational research" "Thierry Van den Bosch" "Woman and Child, Urogenital, Abdominal and Plastic Surgery" "Optimal customized patient management is based on adequate diagnosis, early detection of possible problems and accurate risk stratification. The present research will focus on the role of 3D-ultrasonography in early pregnancy complications (e.g. ectopic pregnancy, non-viable pregnancy, retained products of conception) and early obstetrical risk stratification (e.g. for abnormal placentation, vasa praevia, cesarean scar pregnancy). Our project will introduce a standardized imaging and mapping protocol in early pregnancy and evaluate its value in tailoring management. We will also explore the feasibility of artificial intelligence in the automatisation of problem detection and risk stratification using 3D-ultrasound data. Finally, we will evaluate the use of 3D printing in the preoperative preparation, the surgeon’s technical anticipation, and assess its value on surgical outcome." "The first embryo-dependent and -independent programming of endometrial function in early pregnancy: a bovine model." "Jo Leroy" "University of São Paulo, Veterinary physiology and biochemistry" "Subfertility represents a major problem in domestic animals and humans. In cattle but also in women, up to 40% of total embryonic losses occur between days 7 and 16 of pregnancy, indicating that early embryonic mortality is a major cause of reproductive failure. A finely tuned synchrony between the competent embryo and a receptive endometrium is the key for optimal embryo development and the establishment of a successful pregnancy. Several studies have indicated the existence of complex paracrine and endocrine in vivo communication between early embryo and the maternal tract in mammals. However, so far there is no evidence that the embryo significantly interacts with the endometrium before elongation in the cow (begins 13 days post-mating) or before real implantation in human (day 10-17), while most of the early embryonic losses happen at that time. To understand the pathways of early pregnancy loss we have to elucidate the physiological molecular and biochemical processes underpinning and regulating the earliest maternal-embryonic cross talk upon the moment of embryo arrival in the uterus. In the present project, using the cow as a proven research model to study the very first developmental stages of the pre-implantation embryo, our central aim is to study the embryo/conceptus and endocrine programming of the endometrium to support pregnancy success. In the first part of the PhD research (Milestones 1 and 2, conducted at the University of São Paulo) we hypothesized that exposure to an embryo changes the abundance of specific transcripts and the biochemical composition of the uterine fluid in the cranial region of the pregnant uterine horn. As such an effect is likely to be very local in nature, we developed an in vivo model that allowed sampling the endometrium closer to the embryo (Sponchiado et al., 2017). To limit the use of experimental animals, in the second part of the PhD research (Milestone 3), we propose to use an innovative in vitro co-culture system to investigate the nature of the specific interaction between bovine embryos and endometrial epithelial cells and how this ultimately may affect early embryo quality. This part of the project will be conducted at the University of Antwerp. The proposed combination of in vivo and in vitro systems with state-of-the art analytical tools of transcriptome and metabolomic research should reveal a plethora of candidate genes and bioactive molecules to understand the pathways of the very first embryo-maternal dialogue. The very first communication between the mother and her embryo is undoubtedly one of the most exciting processes in reproductive biology. The knowledge of these mechanisms should help to understand the problem of early embryo mortality and pregnancy loss leading to disappointing fertility results. Only then it will be possible to build on preventive and even therapeutic measures impacting in pregnancy success both in human and agricultural application." "Heat Indicators for Global Health (HIGH Horizons): monitoring, Early Warning Systems and health facility interventions for pregnant and postpartum women, infants and young children and health workers" "Olivier Degomme" "Department of Public Health and Primary Care, Lund University, Technical University of Denmark, Centre for Sexual Health and HIV AIDS Research, WITS HEALTH CONSORTIUM (PTY) LTD, AGA KHAN HEALTH SERVICE KENYA LBG, Karolinska Institute, University of Graz, World Health Organization" "Climate change has impacted people worldwide. In some places its impact can lead to natural disasters, while in others it leads to extremes of heat or cold. Particularly vulnerable groups like pregnant women, infants, frontline health workers and older citizens can be significantly affected by these changes. The EU-funded HIGH Horizons project aims to better prepare us for these eventualities by developing personalised early warning systems, studying the impact of extreme heat on vulnerable groups and preparing health facilities to assist them." "The Belgian Diabetes in Pregnancy follow-up study (BEDIP FUS)" "Katrien Fouzia Benhalima" "Clinical and Experimental Endocrinology" "Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. Women and children with a history of GDM have a high risk to develop type 2 diabetes (T2DM) after delivery. In this research project we will investigate how the long-term metabolic risk can more accurately be predicted in a follow-up cohort of the ‘Belgian Diabetes in Pregnancy study’ (BEDIP-N). We will study the relationship between maternal weight, degree of body fat and degree of evaluated sugar levels in pregnancy on the long-term metabolic risk of at least 906 women and offspring pairs 3-7 years after the delivery across different gestational glucose tolerance groups. In addition, we will study whether a promising new biomarker, glycated CD59, is a good predictor for the long-term metabolic risk." "Medication use during preconception, pregnancy and lactation: towards safe and rational use enhanced by community pharmacists' counseling" "Veerle Foulon" "Clinical Pharmacology and Pharmacotherapy, Woman and Child" "Medication use during preconception, pregnancy and lactation: towards safe and rational use enhanced by community pharmacists' counseling - Michael CeulemansInternational research has shown that pregnant and lactating women commonly use medicines. Besides medication use, women can also be exposed to other health products, such as folic acid, multivitamins and herbal remedies, as well as to substances. To reduce the risk for neural tube defects, all women trying to get pregnant are advised to start folic acid intake prior to conception. In contrast, the use of substances such as alcohol and tobacco is strongly discouraged during pregnancy and lactation due to negative obstetric, fetal and neonatal outcomes.Pregnancy and lactation are unique situations where the benefits of pharmacological treatment have to be weighed against potential risks for the unborn or nursing infant. The available evidence suggests that pregnant women might overestimate the teratogenic risk of medicines and that their beliefs about medicines are important predictors of medication avoidance. To make informed decisions, women need reliable information about medicines. However, inaccurate information and inconsistencies between different sources have been observed, which can lead to anxiety, discontinuation of medicines or early cessation of breastfeeding. Hence, understanding of women’s beliefs about medicines and their information needs is important for healthcare professionals (HCPs) to appropriately counsel these women.As medication experts, community pharmacists do have the potential to optimize the safe and rational use of medicines in the community setting. A specific high-risk population that would benefit from appropriate counseling on the use of medicines and health products are women trying to get pregnant, pregnant and breastfeeding women. Although the current evidence on the role of pharmacists during preconception, pregnancy and lactation is scarce, the available literature points towards lack of knowledge and inadequate counseling. To collect reliable evidence-based information regarding this topic, HCPs employed in many countries can appeal to Teratology Information Services (TIS). However, a TIS does not exist in Belgium yet.The general objective of this PhD project was to contribute to the safe and rational use of medicines during preconception, pregnancy and lactation, including the investigation of the role of community pharmacists in this regard. The PhD project further served as needs assessment for the establishment of a TIS in Belgium.The research project was divided into two parts. The first part aimed to collect epidemiological data in Belgium regarding the use of medicines and health products during pregnancy and, to a lesser extent, during lactation. The second part aimed 1) to explore community pharmacists’ attitudes, barriers, knowledge and counseling practice, and 2) to assess the impact of a blended learning program on pharmacists’ barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation.This PhD manuscript starts with a general introduction on the topic which is partially based on a narrative review that has been published as part of the doctoral research project (Chapter 1). The overall and study-specific objectives are explained in Chapter 2.The first part of the results’ section describes the findings of the epidemiological research on medication and health products’ use during pregnancy and lactation, and consists of four chapters (Chapters 3-6). The results obtained during the PREVIM-study and described in Chapter 3 show that pregnant women living in Belgium frequently use medicines, pregnancy vitamins, and other health products. In line with this observation, the PREVIM-study pointed towards counseling opportunities as to avoid a potential risk for drug-drug interactions, exposure to inappropriate health products, purchasing health products without any medical counseling and initiation of the use of health products on own initiative. In addition, the PREVIM-study showed that preconception lifestyle changes such as folic acid intake and alcohol and smoking cessation are still poorly implemented, corroborating the need for nationwide strategies to improve preconception care in Belgium.In Chapter 4, pregnant women’s beliefs about medicines and information needs measured as part of the PREVIM-study are reported, along with patient characteristics associated with beliefs. To collect research data, women were asked to complete the general and pregnancy-specific statements of the beliefs about medicines questionnaire. Pregnant women reported to have a higher threshold to use medicines during pregnancy compared to non-pregnant situations. About 40% of women preferred natural remedies during pregnancy. Education in healthcare and education level were the main determinants associated with beliefs, with highly educated women showing a higher threshold to use medicines during pregnancy. Furthermore, pregnant women showed high information needs, including for information about medicines during pregnancy. However, less than one third discussed online retrieved information with HCPs. This paper showed that HCPs should consider women’s individual beliefs, guide women towards reliable websites, and discuss online retrieved information and perceived risks and benefits of medicines during counseling.In Chapter 5, the experiences of Arabic-speaking pregnant women with a migration background and living in Belgium were explored. We focused on their communication with HCPs as well as their perceptions towards HCPs and the use of healthcare products during pregnancy. The results of the 17 semi-structured interviews showed that most women were suffering from the language barrier, which hindered their communication with HCPs and had undesirable consequences on their treatment and medication use. Obviously, the communication was largely affected by the presence of interpreters. In addition, a high threshold to use medicines during pregnancy and a preference for natural remedies was observed. Overall, it was concluded that this subgroup of pregnant women is a vulnerable target group for prenatal counseling on medicines. The paper showed that, besides early dectection and willingness to help these women, HCPs should refer these women to appropriate and understandable websites and provide evidence-based information on the use of healthcare products during pregnancy. To facilitate the patient-HCP communication, strategies are highly needed to encourage these women to learn a national language and to increase their social integration.In the absence of a TIS in Belgium, the National Poison Center might act as a substitute center for answering pregnancy and lactation related questions regarding medication use. To investigate the current role of the National Poison Center, a retrospective analysis of pregnancy and lactation related calls involving health products and received by the Belgian Poison Center between 2012-2017 was performed. The results, as described in Chapter 6, showed that the Poison Center received almost daily calls from patients and HCPs on medication exposure during pregnancy and lactation. Many questions involved over-the-counter medicines such as paracetamol and ibuprofen. However, given the safety issues related to other involved products, seeking for advice was justified. In conclusion, the study findings underlined the importance of evidence-based counseling of pregnant and lactating women, and encourage HCPs to engage more actively when counseling on the safe and rational use of medicines during pregnancy and lactation. On top of that, the findings contribute to the ongoing discussion to establish a TIS in Belgium.The first part of the PhD project showed counseling opportunities for HCPs to optimize the safe and rational use of medicines and health products during preconception, pregnancy and lactation. In the second part of the PhD project, the counseling role of community pharmacists during preconception, pregnancy and lactation was investigated in the ECTOPIC-study. The results of the ECTOPIC-study are described in Chapter 7 and 8.In Chapter 7, pharmacists’ attitudes, barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation was explored. Overall, pharmacists acknowledged to have an important role in providing pharmaceutical care during preconception, pregnancy and lactation, but reported to currently not provide the presented services to most patients, which was confirmed during the mystery shopping showing inadequate information gathering, dosing errors and lack of provided information. Several barriers were identified hindering the implementation of pharmaceutical care, such as difficulties to identify the woman’s status and lack of knowledge. Likewise, challenges regarding adequate staffing of pharmacies and the role and educational background of pharmacy technicians were observed. In any case, the findings underscored the urgent need for educational programs to improve pharmacists’ knowledge and counseling on this topic.In Chapter 8, the impact of an educational intervention (i.e. a blended learning program) on pharmacists’ barriers, knowledge and counseling practice with regard to pharmaceutical care during preconception, pregnancy and lactation was evaluated. In general, the blended learning improved pharmacists’ barriers and short- and long-term knowledge. However, pharmacists’ counseling practice only partially improved after the training, as poor information gathering, dosing errors and incomplete information was still observed. Hence, the blended learning program did not result in the full implementation of pharmaceutical care during preconception, pregnancy and lactation. The increased prevalence of barriers such as lack of privacy and lack of time after the training showed that the implementation of pharmaceutical care services is associated with other challenges besides lack of education. As pharmacists’ knowledge declined again over time, regularly repeating the content of the training is needed to maintain the newly acquired knowledge. In the closing chapter of the PhD manuscript (Chapter 9), the general discussion of the findings, methodological considerations, recommendations for pharmacy practice and healthcare policy, as well as future research perspectives are provided.To conclude, the results obtained as part of this PhD project and described in this manuscript show that pregnant women in Belgium commonly use medicines and health products, despite a higher threshold to use medicines during pregnancy and high information needs about medicines. Furthermore, pregnant women may also use health products without informing their HCPs and purchase some of these products even without any medical counseling. As medication experts, community pharmacists are committed to provide pharmaceutical care during preconception, pregnancy and lactation, but admitted not to provide pharmaceutical care to most women yet, mainly due to a lack of education. A blended learning program to tackle pharmacists’ challenges did improve their knowledge and, to a certain extent, the counseling practice, although counseling opportunities still exist. From a public health perspective, the uncertainty and high prevalence of questions among patients and HCPs as well as the paucity of evidence regarding the safe and rational use of medicines during preconception, pregnancy and lactation explicitly underscore the urgent need to establish a TIS in Belgium. " "Impact of COVID-19 pandemic on pregnancy and health of newborns in Belgium." "Adelheid Soubry" "Epidemiology Research Group" "There is growing evidence from literature that maternal and perinatal outcome parameters in pregnancies are complicated by COVID-19 infection or related stress (e.g., from lockdown and risk for infection). In general, clinical characteristics of COVID-19 in pregnant women have been compared to the non-pregnant infected population.  Next, some early observational designs are showing conflicting associations between the COVID-19 pandemic time period and neonatal outcomes.In the current approach we will compare several subgroups of women who consulted the UZ Leuven Clinic between 2018 and 2021. Roughly, we will explore different windows of exposure. Those who were pregnant before the pandemic/lockdown, those who were pregnant during the pandemic/lockdown, and those who were planning to get pregnant during the pandemic/lockdown.The primary aim of this retrospective cohort study is to assess the impact of the COVID-19 pandemic and lockdown on pregnancy outcomes and complications of pregnancies. Within this group of future mothers we will also explore pregnancies diagnosed with COVID-19 infection (positive result on PCR test) vs. non-COVID-19-infected pregnancies (negative result on PCR test).The secondary aim is to provide recommendations on hospital management of pregnant women during a pandemic or other societal crises related to the “Barker paradigm”. Insights will be developed to support future patient (self)management, vaccination strategies and organization of health care for future mothers." "The development and validation of a prototype of a Belgian data registration system on medication use during pregnancy and lactation (BELpREG-project)" "Veerle Foulon" "Clinical Pharmacology and Pharmacotherapy, Woman and Child, Dynamical Systems, Signal Processing and Data Analytics (STADIUS), Academic Center for General Practice, Mind-body Research" "Information on risks caused by medication use during pregnancy and lactation is currently lacking for most substances. This creates uncertainty and anxiety among women and healthcare professionals, which in turn might lead to unnecessary pregnancy terminations, medication reluctance and early cessation of breastfeeding. As RCTs are generally not feasible during pregnancy and lactation, opportunities to conduct observational research should be maximally exploited. However, systematic data registration is currently lacking in Belgium. Therefore, this project aims to develop and test a prototype of a robust, evidence-based data registration system on medication use during pregnancy and lactation and maternal-infant health outcomes that will be of utmost value for researchers and pharmaceutical industry." "PRegnancy Exposome influence on early-life COgnition via CholEsterol metabolism at birth (PRECOCE)" "Michelle PLUSQUIN" "Environmental Biology" "Cholesterol levels at birth are not routinely measured as they are thought to be of scarce clinical relevance. In adults, recently, cholesterol has emerged as possibly connected to neurological disorders. Cognitive development starts as early as in the womb. In utero life represents a critical window of development, during which the brain is particularly vulnerable to environmental influences. Detrimental exposures in this critical life period may impact brain functions leading to long lasting effects. However, molecular mechanisms underlying this association are poorly known. In this project, I aim to study the role of the cholesterol metabolism, and its related multi-OMIC signatures, at birth in the association between prenatal exposures and cognition phenotypes in early life (at 4 and 10 years) in the ENVIRONAGE cohort. In collaboration with international experts, I will study the persistent effects of prenatal exposures, using an exposome approach, on cognition in childhood and explore their indirect effect through cholesterol levels at birth and its related DNA methylation signatures. By unraveling cholesterol-related mechanisms linking prenatal exposures and cognitive development at an early age, this project can support the public health importance of monitoring blood cholesterol levels in early life and contribute to a healthier living environment for pregnant mothers and their children." "PRENOM II : Pregnancy remote monitoring of women at risk for gestational hypertensive disorders" "Wilfried GYSELAERS" "Limburg Clinical Research Center, Cardio & organ systems, Immunology - Biochemistry, Physiology" "The goal of this project is to thoroughly evaluate the added value of a remote monitoring (RM) program for women at risk for gestational hypertensive disorders (GHD), by conducting a multicenter randomized controlled trials at 4 MIC centers in Flanders, and investigating its impact on prenatal follow-up, health outcomes for mother and child, costs and satisfaction. With PREMOM II, we want to complete the following triple aim: 1) Improvement of the health: less complications for the mother and the neonate due to GHD 2) Improvement of the quality of care: an early detection of (the development of) GHD and a more intensively follow-up for the women who need this. 3) A reduction of the health cost per capita: less consumption of care, less consultations and hospitalizations, a reduction of cost due to complications for both the mother and child. Our specific objectives are: - A multicentric, pragmatic RCT in four Flemish MIC departments: this to investigate the impact of RM in a prenatal follow-up program for women with GD on: (1) prenatal follow-up and health care consumption: (2) pregnancy outcomes, for both the mother and the neonate; (3) costs for the health care society, both on the long-term and on the short-term. - Trying to understand which is exactly the added value of RM by (1) set up a group of pregnant women which measure their vital parameters by themselves, but without the supervision of a midwife; (2) by the consequent registration of the timing of the interventions and their effects on the blood pressure and the development of GHD. - Questioning the satisfaction and the perceptions of the midwives, the obstetricians and the recently delivered women regarding their prenatal follow-up - A cost - effectiveness analysis and the willingness to pay of this prenatal follow-up program."