[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-for-gestational-age-sga\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-for-gestational-age-sga":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,60,105,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":4},"100635983","the-root-study-scaling-the-standard-of-care-plus-obstetric-nutrition-model-to-optimize-maternal-and-infant-health-100635983",false,"NCT07559773","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health","The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Integrated Model to Optimize Maternal and Infant Health: a Prospective Interventional Study: Resilient Outcomes Through OB-Nutrition Team Care (ROOT)","ROOT","Inclusion Criteria:\n\n* Pregnant women receiving care at NH Triad OB\u002FGYN\n* ≤20 weeks gestational age at enrollment\n* Age ≥ 18 years (\\\u003C18 years requires parental consent)\n* Ability to provide informed consent\n* Access to smart phone\u002Finternet for digital platform use\n\nExclusion Criteria:\n\n* \\> 20 weeks gestational age\n* High-risk pregnancies requiring specialized care beyond study scope\n* Inability to participate in digital health platform\n* Cognitive impairment preventing informed consent","FEMALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC).\n\nIn 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \\\u003C0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size.\n\nStructured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure.\n\nThe primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics\u002FGynecology (OB\u002FGYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone.\n\nThe secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone.\n\nParticipant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.",[27,28,29,30,31,32,33,34,35,36],"Preterm Birth","Preeclampsia","Gestational Diabetes Mellitus (GDM)","Small for Gestational Age (SGA)","Large for Gestational Age (LGA)","Asthma Childhood","Atopic Dermatitis","Autism","Otitis Media Recurrent","Obesity",[38,39,40,41,42,43,44,45,46,47],"adverse pregnancy outcomes","prevention","personalized nutrition","nutrigenomics","adverse neonatal outcomes","childhood asthma","childhood allergy","autism","childhood obesity","recurrent otitis media","NOT_YET_RECRUITING","2026-04-27",{"date":51,"type":52},"2026-04-30","ACTUAL",{"date":54,"type":21},"2026-08",{"date":56,"type":21},"2033-12",{"name":58,"class":59},"GrowBaby Life Project","OTHER",{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":17,"minAge":18,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100571679","phase-3-asymptomatic-bacteriuria-in-pregnancy-in-low--and-middle-income-countries-100571679","NCT06723392","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research","ABLE","Inclusion Criteria:\n\nIndividuals who meet the following criteria are eligible for randomization:\n\n* Enrolled in GN MNHR\n* Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and\u002For clinical assessment and\u002For ultrasonography\n* Age: 18 years (or lower limit age eligible\\*) to 49 years\n\n  \\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.\n* Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up\n* Able to provide informed consent\n* Presence of a single bacterial isolate (\\>105 colony forming unit (CFU)\u002FmL) in urine at enrollment\n* Intent to remain in study area for at least 42 days PP\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible for randomization:\n\n* Gestational age \\\u003C12 weeks or \\>20 weeks\n* Received treatment with any antibiotic within 14 days before screening visit\n* Current symptoms of UTI\n* History of allergy to nitrofurantoin\n* Pregnancy loss \u002F miscarriage prior to randomization\n* Currently taking magnesium-containing antacid\n* Any illness \u002F condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment\n* Enrollment in another trial that per the study MOP will impact this trial",true,"49 Years",{"count":71,"type":21},1134,[73],"PHASE3","This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \\[End preventable deaths of newborns and children under 5 years of age\\] by examining the potential impact of this practice to reduce the incidence of SVN\u002FSB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).",[27,30,76,77],"Stillbirth","Bacteriuria (Asymptomatic) in Pregnancy",[79,80,81,82,83,84,85,86,87,88,89,90,91,92],"asymptomatic bacteriuria","small vulnerable newborn","preterm birth","small for gestational agea","still birth","SVN\u002FSB","oral nitrofurantoin monohydrate\u002Fmacrocrystals","Global Network","Bangladesh","India","Pakistan","Democratic Republic of Congo","Zambia","Guatemala","RECRUITING","2026-01-20",{"date":96,"type":52},"2026-01-22",{"date":98,"type":52},"2025-12-08",{"date":100,"type":21},"2028-11",{"name":102,"class":103},"NICHD Global Network for Women's and Children's Health","NETWORK",7,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":68,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":124,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100589696","biological-impacts-of-rising-temperatures-on-maternal-fetal-and-newborn-health-a-cohort-study-birth-cohort-100589696","NCT06957769","Biological Impacts of Rising Temperatures on Maternal, Fetal, and Newborn Health: A Cohort Study (BIRTH Cohort)","BIRTH","Inclusion Criteria:\n\n* Single or multiple live pregnancy confirmed through ultrasound\n* Gestational age less than or equal to 13 weeks and 6 days at enrollment\n* At least 18 years of age\n* Permanent resident of the study district and plans to deliver within the district\n* Willing and able to attend study clinic visits and comply with study procedures throughout pregnancy\n\nExclusion Criteria:\n\n• Plan to relocate outside the district for more than 3 months during the study period",{"count":113,"type":21},6000,"OBSERVATIONAL","The goal of this study is to learn how being exposed to high environmental temperatures during pregnancy affects the health of pregnant women and their babies. The study also aims to understand how the body responds to heat stress during pregnancy and how this might lead to pregnancy complications and birth problems like early birth or low birth weight.\n\nThe main questions that the study aims to answer are:\n\n1. What are the acute and chronic effects of environmental heat exposure on pregnancy and birth outcomes across different trimesters?\n2. Through which biological pathways does heat stress impact maternal, fetal, and infant health across varying gestational ages?\n3. How do socio-demographic factors, maternal characteristics, and nutritional status of women modify the relationship between environmental heat exposure and adverse pregnancy outcomes?\n\nThe study will take place in rural parts of Sindh, Pakistan. These areas often experience extreme heat and have limited access to electricity or cooling systems like fans or air conditioners.\n\nThis study will include pregnant women who are in their first trimester (under 14 weeks of pregnancy). Before starting any study activities, researchers will explain the study to each woman in a language she understands and ask for her written permission to take part (informed consent).\n\nAt the beginning of the study, participants will visit a study clinic. During this visit, researchers will check their height and weight, perform an ultrasound, and collect a small amount of blood for testing. Participants will also be asked to wear a small device that measures the air temperature and humidity in their surroundings.\n\nThe researchers will follow each participant during her pregnancy, with visits during the second and third trimesters at the study clinic. At each visit, researchers will check how much heat the participant has been exposed to using the data from the device and from her own answers to a simple questionnaire. The questionnaire will have questions about their heat exposure at work, home, type of clothing, and how they deal with hot weather. Serial ultrasound, blood and urine tests will be conducted so researchers can study signs of stress, hydration, and other changes in the body. A smaller group of participants will also wear a device to measure their body skin temperature, heart rate, physical activity and sleep during pregnancy.\n\nWhen the baby is born, researchers will collect information about the birth, including the baby's weight and length, the time of delivery, and whether there were any complications during birth. After delivery, both the mother and baby will be followed for up to 12 months. During this time, the research team will check the health of both the mother and baby and see how heat exposure during pregnancy may affect the baby's growth over time. At delivery, placental weight and volume will be collected for a smaller group of women. Breastmilk sampling will also be done for this group of women to understand the effect of high temperatures on breastmilk quality.\n\nThis study does not involve any treatment or medicine. Instead, researchers will observe the participants to learn how real-life heat exposure affects them during pregnancy. The findings from this study may help public health officials and governments find better ways to protect pregnant women and babies from the harmful effects of climate change and extreme heat, especially in places with limited resources.",[117,30,27,118,119,120,121,122,123],"Low Birth Weight Baby","Pregnancy Complications","Birth Outcome, Adverse","Heat Strain","Infant Morbidity","Infant Mortality","Neonatal Mortality",[125,126,127,128,129,130,89],"heat stress","high ambient temperature","climate change","birth outcomes","pregnancy","cohort study","2025-11-26",{"date":133,"type":52},"2025-12-03",{"date":135,"type":52},"2025-05-07",{"date":137,"type":21},"2028-06-30",{"name":139,"class":59},"Aga Khan University",3,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":68,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":150,"studyType":114,"phases":4,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100586658","association-of-assisted-reproductive-technologies-parameters-with-the-perinatal-outcome-100586658","NCT06918236","Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome","Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome in Singleton and Multiple Pregnancies: A Multicenter Prospective Cohort Study","Inclusion Criteria\n\n* Singleton or multiple pregnancies\n* Live fetus between 11 weeks plus 0 days and 13 weeks plus 6 days of gestation\n\nExclusion Criteria\n\n* Known genetic anomalies diagnosed before or after birth\n* Major fetal defects diagnosed before or after birth, such as acrania, holoprosencephaly, megacystis, exomphalos, congenital heart defects",{"count":149,"type":21},12084,"9 Months","The goal of this prospective cohort study is to examine how different parameters of assisted reproductive technologies (ART) are associated with the perinatal outcome in individuals with singleton or multiple gestations. The main questions it aims to answer are:\n\nAre ART pregnancies associated with a higher risk of:\n\n* Small for gestational age neonates?\n* Fetal growth restriction, either early- or late-onset?\n* Development of preeclampsia?\n* Stillbirth (intrauterine fetal death after 22 weeks not due to known anomalies)?\n* Are certain ART parameters-such as the type of fertilization (e.g., IVF vs. ICSI), embryo stage at transfer, use of fresh vs. frozen embryos, or ovarian stimulation protocols-more strongly associated with adverse outcomes?\n\nAre ART pregnancies associated with placental and umbilical cord abnormalities, including:\n\n* Placenta previa?\n* Vasa previa?\n* Single umbilical artery?\n* Velamentous or marginal cord insertion?\n\nResearchers will compare outcomes between pregnancies conceived through ART and those conceived spontaneously.\n\nParticipants will:\n\n* Be individuals aged 18 or older undergoing routine first-trimester ultrasound between 11 and 14 weeks of gestation\n* Provide detailed medical, obstetric, and ART-related information\n* Undergo routine prenatal assessments, including ultrasound evaluations of fetal growth, Doppler studies, and placental characteristics\n* Have perinatal outcomes such as gestational age at birth, mode of delivery, birthweight, and complications systematically recorded\n\nStatistical models will be used to adjust for confounding factors such as maternal age, BMI, parity, and smoking.\n\nThe aim is to better understand how ART and specific ART parameters may influence maternal and neonatal health and to improve counseling and clinical care for people using fertility treatments.",[153,28,76,154,155,30],"Fetal Growth Restriction (FGR)","Placenta Previa","Vasa Previa",[157,28,158,159,160,161,162,30,163,164],"fetal growth restriction","stillbirth","placenta previa","vasa previa","Assisted reproductive techniques","ART","IVF","ICSI","2025-04-05",{"date":167,"type":52},"2025-04-09",{"date":169,"type":52},"2024-10-01",{"date":171,"type":21},"2028-12",{"name":173,"class":59},"Aristotle University Of Thessaloniki",6]