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IRB No. 17-180H-6.2 (Dr. Erin Mead-Morse, PI): Electronic Cigarette Use During Pregnancy HHC-2017-0208

An observational, longitudinal, prospective cohort study of 375 women (125 women who smoke conventional cigarettes exclusively during pregnancy, 125 who use e-cigs and 125 dual users). Background: Maternal smoking is one of the most important modifiable causes of poor pregnancy outcomes in the United States causing 16% low birth weight babies, 6% of premature deliveries, and 6% of preterm related deaths. Quitting smoking is the best option to improve maternal and child health, and smoking reduction is also beneficial. However, an increasing number of pregnant smokers may be using electronic cigarettes (e-cigs) as a substitute for or in conjunction with cigarette smoking. Rationale for this study: E-cigs are an emerging public health issue. They may have a net benefit or risk. A need exists to evaluate the impact of e-cigs in vulnerable populations such as pregnant women. The information about the potential risks and benefits is needed to adequately inform pregnant women and health care providers who counsel their patients. Study Design: This is an observational, longitudinal, prospective cohort study. Study Population and Sample Size: Pregnant smokers who exclusively smoke conventional cigarettes, or who use e-cigs. A total of 375 subjects (125 who smoke conventional cigarettes and 125 who use e-cigs, and 125 dual users) will be enrolled across six sites (UCHC, HH, Baystate Medical Center, University of Colorado, Denver Health, and University of East Tennessee). Major Study Interventions: Not a treatment study. Observational only. Providing written smoking cessation education materials and referral to state Quitline if needed. Main Outcome Measures/Analyses: To determine if e-cigarettes use leads to lower exposure to toxicants in pregnant women relative to those pregnant smokers who smoke conventional cigarettes. Hypotheses, aims and objectives: Hypothesis 1: We hypothesize that women who smoke conventional cigarettes will have higher urine NNAL and serum cotinine & benzene levels compared to users of e-cigs (dual users or exclusive users). Aims / objectives 1: To compare the overall toxicant exposure in pregnant women who use e-cigs to women who smoke conventional cigarettes Hypothesis 2: We hypothesize that infants born to women who smoke conventional cigarettes will have higher levels of NNAL, benzene/SPMA and cotinine compared to infants born to users of e-cigs (dual or exclusive users). Aim/Objective 2: To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes Hypothesis 3: We hypothesize that maternal urine for NNAL will be predictive of birth weight, and that this effect will be mediated by inflammatory processes, measured using markers of inflammation [high sensitivity C-reactive protein (hs CRP) and intercellular adhesion molecule (ICAM-1)]. Any additional effect of benzene/SPMA will be explored. Aim/Objective 3: To explore potential mechanisms by which toxicants could influence birth weight.

IRB No. 19-145J-2 (Dr. Danielle Luciano, PI): Cellular Phenotyping of Endometriosis – Towards Biomarker Discovery and a Mechanistic Understanding of Disease

Endometriosis is a common gynecological disorder that results when tissue that normally lines the inside of a woman';s uterus - the endometrium - grows outside the uterus. The tissue forms large lesions that most typically implant in the ovaries, fallopian tubes and the tissue lining the pelvis, causing severe and debilitating pain, fatigue and infertility. The condition can only be diagnosed through surgical removal of lesions and treatment is aimed primarily at managing the pain symptoms. Removal of endometriosis lesions offers temporary relief, but lesions and their associated symptoms frequently recur in patients. There is no cure. Endometriosis is a significant health and economic burden owing to disability and lost productivity among women. A major reason why we lack options for diagnosing and treating endometriosis is because our understanding of the fundamental mechanisms of disease remains poor. Understanding the cell types and cell-type-specific gene expression patterns in the lesion and the surrounding environment is a foundational step that will inform hypotheses on the etiology and pathogenesis of disease and reveal the molecular factors that could represent viable targets for diagnostic and therapeutic development. We hypothesize that the local environment creates conditions for endometriotic lesions to develop and invade surrounding organs, and that both the lesion and lesion-adjacent tissues contain factors that could represent viable targets for biomarker-based diagnostics and therapeutics. To investigate our hypothesis, we will employ cutting-edge technologies for investigating the gene-expression patterns of single cells, and for high-resolution imaging to understand how different cell types comprising a tissue are spatially arranged. We will perform these experiments in human endometriotic lesions from the pelvic cavity, in tissue immediately adjacent to the lesion (to begin to understand the molecular features of the local environment), and in healthy endometrial tissue. We will use computational algorithms to compare the different gene expression patterns and to correlate these patterns with specific cell types. We will then analyze the spatial arrangement of these cell types to understand the cell-cell interactions that could help lesions to establish and grow. This work will yield the first, comprehensive profile of the endometriosis ";ecosystem"; along with a list of expressed genes that researchers can use to form new hypotheses about disease etiology. This list of expressed genes will likely contain molecular factors that could be developed into biomarkers or therapeutic targets.

IRB No. 21-143OSC-1 (Dr. Damion Grasso, PI): Impact of Perinatal Pandemic-Related Stress on the Early Caregiving Environment, Infant Functioning, DNA Methylation, and Telomere Length

The current study seeks to recruit a diverse cohort of women and their partners who were in the final two trimesters of pregnancy during the COVID-19 pandemic. Phase 1 of the study will involve a large-scale survey (N=2,000) of these individuals to assess perinatal stress exposure occurring in the context of the pandemic. Phase 2 will involve selecting individuals from the Phase 1 survey to establish two subgroups with high (n=200) and low (n=200) perinatal pandemic-related stress exposure to participate in a comprehensive and longitudinal assessment protocol, including interviews, parent-child interactions, an infant stress paradigm, and biological sample collection. Aims are to: (1) use person-centered latent class analysis of perinatal pandemic-related experiences to identify unique profiles that vary on the types and quantity of stress exposure and differentially associate with race/ethnicity, caregiver-reported perceived stress, emotion dysregulation, PTSD, parenting, and infant dysregulation (stress-reactivity and emotional/behavioral problems) in the large Phase 1 survey cohort (N=2,000); (2) Compare infants with high and low perinatal pandemic-related stress and examine caregiver emotion dysregulation, PTSD, and responsive parenting as potential mediators of this relationship in the longitudinal Phase 2 cohort (N=400); and (3) identify differentially methylated regions of DNA and differences in telomere length and changes over time in infants in high v. low perinatal stress groups. Assessment procedures will integrate the experiences and functioning of both the mother and partner when considering implications for offspring. This work will yield mechanistic insight on how pandemic-related stress, caregiver emotion dysregulation, and PTSD influence multiple aspects of the caregiving environment and infant outcomes and is expected to directly inform perinatal public health interventions as the COVID-19 pandemic continues and its sequelae unfold.

IRB No. 23-179-1 (Dr. Andrea Shields, PI): Xenobiotic transfer of Tranexamic acid (TXA) using an ex vivo placental perfusion model: a pilot study

To our knowledge, there are no studies that have researched if tranexamic acid (TXA) has an effect on the placenta, or if there is considerable transfer of the drug from maternal to fetal circulation. We propose studying the transfer of the drug on a single placental lobule of 7 placentas. We hypothesize that given the large molecular composition of tranexamic acid there will be minimal transfer of the drug in the ex-vivo placental perfusion model, thus providing safety data on the administration of tranexamic acid for therapeutic indications especially during pregnancy. The specific aims are: 1) To set up and troubleshoot the placental perfusion model using 3-5 placental lobules 2) To measure and compare the levels of therapeutic tranexamic acid in the maternal versus fetal perfusate collected from an ex-vivo placental perfusion model.

IRB No. 23-190SSF-2 (Dr. Andrea Shields, PI): Meals 4 Moms: Development and Feasibility of a Multilevel Community-based Lifestyle Intervention for Gestational Diabetes

Gestational Diabetes Mellitus (GDM) affects 2-10% of pregnancies in the US and 50% of GDM patients will progress to develop Type II Diabetes Mellitusin their lifetime. GDM can also cause pregnancy complications including antepartum hospitalization, cesarean delivery and longer length of stay during antepartum or delivery admissions. Improving pregnancy outcomes involves patients understanding and adopting to an ADA specific diet, daily glucose monitoring and physical activity and compliance with prenatal visits. Providing education during pregnancy is the optimal window of opportunity for the prevention of diabetes. In Phase 1 of the study, the team of investigators will develop a novel, personalized lifestyle intervention (Meals 4 Moms Bundle) for pregnant patients diagnosed with GDM to supplement the usual care and education that is provided to such patients. The bundle will include additional GDM education, nutrition and exericse guidance, GDM meal kit delivery and support. Prior to implementation of the bundle, focus groups (with current GDM patients) to solicit feedback on the bundle materials will be conducted. Phase 2 of the study will involve a pilot feasibility randomized clinical trial which includes UConn Health patients diagnosed with GDM. Patients will be randomly assigned to receive usual obstetrics care for patients who are diagnosed with GDM or usual care plus the Meals 4 Mom Bundle. The clinical trial will assess the feasibility and acceptability outcomes of recruitment rate, retention, adherence to diet and exercise recommendations and acceptability with the program.

IRB No. 24-132-2 (Dr. Tarunya Vedere, PI): Primary Hyperaldosteronism is a Risk Factor for Developing Hypertensive Disorders of Pregnancy

This research is being done to determine if Primary Hyperaldosteronism (PA) is a pre-pregnancy risk factor for Hypertensive Disorders of Pregnancy (HDP). HDP which includes preeclampsia, eclampsia, gestational hypertension and chronic hypertension complicating pregnancy occur in about 10% of pregnancies and can cause a lifetime risk of developing chronic hypertension and heart disease. This study will look to see if excessive aldosterone hormone levels might be a risk factor for that. Aldosterone is a hormone naturally made in the body that helps keep the water and salt ratios in the body balanced. Excessive aldosterone hormone levels, or PA is a well-recognized cause of hypertension. Patients may be enrolled into the study or control group. Study group patients will have had a previous diagnosis of HDP in a pregnancy no earlier than January 1, 2018. Control group patients do not have any previous HDP diagnoses. Both groups will provide a one time blood draw, providing approximately 1 tablespoon of blood to be tested as well as one urine sample.

IRB No. 23-175HS-1 (Dr. Yanjiao Zhou, PI): Tracking the Microbiome Origin of Inflammation from Mouth to Placenta in Preeclampsia

AIMS Preeclampsia (PE) is defined by high blood pressure and proteinuria in pregnancy. It affects approximately 2-8% of the overall pregnant population and 17-25% of pregnant women with chronic hypertension. It is a leading cause of maternal death. Pathogenesis of PE involves excessive immune response, maternal endothelial dysfunction and abnormal placenta development. However, the initial factors responsible for the development of PE are unknown. Oral microbiota, comprising over 700 different bacterial species, has been linked not only to local periodontal diseases, but also systemic disorders. It has been speculated that oral microbiota can disseminate to placenta through blood circulation, heightening immune response and increasing risk of PE. Indeed, our recent work that tracked the oral and placental microbiome simultaneously in patients showed that the relative abundances of Haemophilus, Veillonella and Fusobacterium in subgingival plaque were significantly higher in patients with PE than matched controls without PE. We also rigorously identified the presence of these oral-like bacteria in placenta of PE patients, in contrast to controls. The preliminary data was based on samples collected at the delivery; thus, it is unclear whether the oral microbiome alteration is an acute process at PE onset or as a result of gradual alteration over the pregnancy term. It is also unclear when placental microbiome seeding occurs. A longitudinal profiling of the oral microbiome during pregnancy is critical to capture the overall dynamics of the microbiome in PE development, and provide novel insight into oral microbiome in pathogenesis of PE. Dysregulation of Th17/Tregs cells is a major contributor of pathogenesis of PE. Recent research showed that oral microbiome alteration in periodontal diseases can trigger Th17 cells to mediate oral mucosal immunopathology in an IL-6 dependent manner. Our preliminary data showed oral-like microbiota in placenta of PE patients were associated with elevated IL-6 in blood, raising a possibility that oral microbiome alteration may contribute to exaggerated immune response in PE through upregulation of IL-6 and Th17 cells. We hypothesize that an altered microbiome-immune interaction during pregnancy contributes to development of preeclampsia. We propose a prospective longitudinal study to determine dynamics of oral microbiome and immune response over different gestation and their association with PE. Aim 1. Determine the dynamics of the oral microbiome throughout pregnancy and their association with PE. We will prospectively enroll 100 patients with chronic hypertension or who meet criteria for being at risk of PE at UConn and Hartford Hospital. We will collect subgingival samples at each trimester and at PE onset, along with placenta at delivery. We will compare the oral microbiome of each trimester and at PE onset between patients who develop and who do not develop PE, and identify PE associated oral microbiome after controlling confounding factors. Placenta microbiome will be correlated with PE and oral microbiome. Aim 2. Determine the dynamics of immune response and immune-microbiome interactions throughout pregnancy. Blood will be collected at the same time as Aim1 in the study participants for immune assay. PBMC will be used to determine immune cell populations by flow cytometry focusing on Th17 and Tregs cells. Serum will be used to measure multiple panels of cytokines and chemokines by high- throughput Luminex assay. We will determine the association of oral microbiome at each trimester and placental microbiome with immune measures after controlling clinical confounding factors. Impact. The study holds promises to gain insight into the pathogenies of PE from a novel oral microbiome-immune interaction perspective, and lay ground work for future to develop non-invasive microbiome markers to predict PE. We will apply a R01 to extend the study to multi-centers to cross-validate the microbiome and immune findings. We also plan to collect and bank stool and vaginal samples from the study to create multiple lines of research on the microbiome and PE at Departments of Medicine and OB/GYN in future.

IRB No. 24-099J-1 (Dr. Timothy Crombleholme, PI): Intra-placental Gene Therapy with Ad-IGF-1 in BPH/5 mice with Mesenteric Uterine Artery Branch Ligation and Association of Pre-eclampsia and IUGR

Pre-eclampsia and hypertensive disorders of pregnancy present major health impact to both mother and fetus. Pre-eclampsia has been linked to maternal multi-organ failure, coagulopathic processes and in fetuses can impact fetal growth leading to growth restriction. The onset of pre-eclampsia is variable but typically onset is after 20 weeks of gestation. However, more severe forms of pre-eclampsia may present with earlier onset and have been linked to more egregious pregnancy complications, such as severe infantile uterine growth restriction (IUGR). Understanding the key mechanisms surrounding pre-eclampsia pathophysiology are vital to helping prevent and or cure this disease. Prior research has shown that the IGF-1 pathway is central in fetal growth and placental development. This project aims to study the pathophysiology of pre-eclampsia by studying the interrelation of IGF-1, a known common maternal and fetal pathway involved in cellular homeostasis. We will enroll mothers with pre-eclampsia, fetal growth restriction

IRB No. 25-016H-2 (Dr. Andrea Shields, PI): Bringing Residents, Fellows and Nurses Back to the Bedside to Support a Mother’s Road to Recovery: Interdisciplinary Trauma-Informed Care Curriculum for Perinatal Care

Physician recognition of impending trauma is highly important to prevent and mitigate possible patient distress. Pregnant women with a history of trauma and adverse childhood experiences can have higher levels of pregnancy related trauma which can exacerbate anxiety, depression, and PTSD symptoms. Trainees in OB/GYN and Labor and Delivery, including residents, fellows, and nurses, not only struggle with recognition of pregnancy-related trauma, but have experienced a higher level of burnout impacting the physician-patient relationship. Our goal is to improve recognition and management of pregnancy-related trauma while embodying a culture of mindfulness amongst OB/GYN residents, fellows, and nurse trainees.

IRB No. 24-111JSF-1 (Dr. Danielle Luciano, PI): The CT EndoRISE Biorepository

According to Connecticut Public Act No. 22-33, the CT EndoRISE biorepository will prospectively collect endometriosis tissues (termed lesions), healthy endometrium, blood, urine, and peritoneal fluid samples along with linked clinical and phenotypic data, symptoms, and quality of life questionnaires from patients with endometriosis and healthy controls. The CT EndoRISE is a collaboration between The Jackson Laboratory for Genomic Medicine and UConn Health.

IRB No. 25-198-2 (Dr. Andrea Shields, PI): Xenobiotic transfer of semaglutide using an ex vivo placental perfusion model: a pilot study

To our knowledge, there are limited studies that have researched if semaglutide has an effect on the placenta or if there is considerable transfer of the drug from maternal to fetal circulation. We propose studying the transfer of the drug on a single placental lobule of 7 placentas. We hypothesize that given the large molecular composition of semaglutide there will be minimal transfer of the drug in the ex-vivo placental perfusion model, thus providing safety data on the administration of semaglutide for therapeutic indications especially during pregnancy. The specific aims are: 1) To set up and troubleshoot the placental perfusion model using 3-5 placental lobules 2) To measure and compare the levels of therapeutic semaglutide in the maternal versus fetal perfusate collected from an ex-vivo placental perfusion model.