[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06407388":3,"trial-entities:NCT06407388":94,"trial-summary:NCT06407388":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":33,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":64,"locations":66,"central_contacts":89,"overall_officials":91,"references":92,"see_also_links":93},"NCT06407388","23-03-FB-0061","Ultrasound Findings in Diabetic Pregnancies","Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies","UNKNOWN","2025-06-01","2024-05","2024-05-09","2023-06-01","Eastern Virginia Medical School","OTHER",false,"The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. Specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (TcB) in the newborn and thus jaundice requiring phototherapy. This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.","This is a single center, prospective case control study. Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (IRB #15-09-FB-0179). If patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks' gestation. Therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. At the time of enrollment, the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (Code 76811). These patients will then be followed prospectively until delivery. The neonates of the study patients will be followed via chart review after delivery.",[19],"Diabetes",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},156,"ESTIMATED",[],[29],{"measure":30,"description":31,"timeFrame":32},"Elevated TcB","The primary objective of this study is to identify if increased fetal liver volumes correlate with elevated transcutaneous bilirubin (TcB) in neonates of mothers with diabetes.","June 2023 to June 2025",[34,37,40,43],{"measure":35,"description":36,"timeFrame":32},"Respiratory Distress","One or more signs of increased work of breathing, such as tachypnea with a respiratory rate \\> 60 breaths per minute, nasal flaring, chest retractions, or grunting \\[13\\] requiring oxygen support",{"measure":38,"description":39,"timeFrame":32},"Jaundice","Jaundice requiring phototherapy",{"measure":41,"description":42,"timeFrame":32},"Hypoglycemia","\\\u003C40 mg\u002Fdl in the first 24 hours of life",{"measure":44,"description":45,"timeFrame":32},"Polycythemia","Hematocrit \\>65% or hemoglobin \\>22 mg\u002Fdl","FEMALE","18 Years","45 Years",{"inclusion":50,"exclusion":55,"raw_text":63},[51,52,53,54],"Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus.","Pregnant women between the ages of 18-45","Live, singleton gestation","Understanding and ability to give informed consent",[56,57,58,59,60,61,62],"Patient unwilling or unable to provide consent","Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)","Age less than 18 years of age","Multifetal gestation","Chromosomal abnormality","Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19","Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)","Inclusion Criteria:\n\n* Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus.\n* Pregnant women between the ages of 18-45\n* Live, singleton gestation\n* Understanding and ability to give informed consent\n\nExclusion Criteria:\n\n* Patient unwilling or unable to provide consent\n* Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)\n* Age less than 18 years of age\n* Multifetal gestation\n* Chromosomal abnormality\n* Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19\n* Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)",[65],"ADULT",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":86},"Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School","RECRUITING","Norfolk","Virginia","23507","United States",[75,80,84],{"name":76,"role":77,"phone":78,"email":79},"Alyssa Savelli, MD","CONTACT","757-446-7900","kawakit@evms.edu",{"name":81,"role":77,"phone":82,"email":83},"Kristin Ayers, MPH","7574460579","ayerskl@evms.edu",{"name":76,"role":85},"PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},36.84681,-76.28522,[90],{"name":81,"role":77,"phone":82,"email":83},[],[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[96],"Diabetes Mellitus",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":109},true,{"design":101,"status":102,"heading":6,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It is a single-center study, and aims to include 156 participants.","completed","This study is looking at how ultrasound pictures of a baby's liver might help predict if newborns of mothers with diabetes will develop jaundice (yellowing of the skin) that needs treatment. Researchers believe that a larger fetal liver (the baby's liver before birth) might lead to higher transcutaneous bilirubin (TcB) levels, which is a measure of jaundice, in the baby after birth. This information could help doctors better advise parents and plan for care. You may be able to join if you are a pregnant woman between 18 and 45 years old with type 1 or type 2 diabetes, carrying one baby, and can give informed consent. The study aims to enroll 156 participants. The study is currently unclear on its recruitment status.","The study will follow participants and their babies until June 2025 to measure transcutaneous bilirubin (TcB) levels in the newborns.",123,"If you agree to participate, one ultrasound will be performed between 30-34 weeks of pregnancy. This ultrasound will be done during your regularly scheduled visit, so no extra appointments are needed. After delivery, your baby's health information will be reviewed from their medical chart.","Not stated in the trial record.",[],"v2"]