[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05229666":3,"trial-entities:NCT05229666":93,"trial-summary:NCT05229666":96},{"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":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":36,"secondary_outcomes":41,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":62,"locations":65,"central_contacts":80,"overall_officials":88,"references":91,"see_also_links":92},"NCT05229666","AAAU9052","Stress Phenotypes and Preterm Birth","Stress Phenotypes and Preterm Birth: Immune and Energetic Cellular Dysregulation and the Preventive Effect of Social Support","RECRUITING","2027-12","2026-05","2026-05-14","2021-12-09","Columbia University","OTHER",false,"Pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women, though more often for Non-Hispanic Black women, 14.12% PTB rate, compared to 9.09% for Non-Hispanic White women. Psychosocial stress and childhood trauma each are associated with risk for PTB and PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. In this project, we will study mitochondria, which contain their own genome, the mitochondria DNA, and are inherited from the mother, as they represent a potential intersection point between psychosocial experiences and their biological embedding in underlying disease outcomes such as PTB","At odds with common assumptions - and hope, pregnancy ends in preterm birth (PTB) for approximately 1 in 10 women. Yearly PTB affects 15 million infants worldwide and 386,580 in the United States. PTB is the leading cause of global, and U.S., neonatal mortality and morbidity and is associated with future risk for poor physical (higher blood pressure, chronic kidney disease, wheeze\u002Fasthma) and mental (ADHD, IQ decrements) health. Maternal health is not spared: women who deliver preterm are at an increased risk for depression, hypertension, cardiovascular and renal disease later in life. In the U.S., the racial and ethnic disparities in PTB rates are dramatic and independent of socio-economic status (SES): overall, 14.12% for Non-Hispanic Black compared to 9.09% for Non-Hispanic White women.\n\nPsychosocial stress and childhood trauma each are associated with risk for PTB. PTB has an intergenerational impact: mothers born preterm are more likely to give birth preterm, especially amongst Black women. Biomarkers to predict PTB have proven unsuccessful, and do not account for this emerging recognition of intergenerational transmission of PTB risk specifically via maternal heritage. Mitochondria, which contain their own genome, the mitochondria DNA, are inherited from the mother and represent a potential intersection point between psychosocial experiences and their biological embedding, including via immune dysregulation, in underlying disease outcomes. We aim to apply a mitochondria psychobiology approach to delineate by which mechanisms life stress - including discrimination and childhood trauma - results in disproportionate risk of PTB in minority women, and evaluate mitochondria as potential biomarkers of this birth outcome.\n\nIn a sample of post-attrition n=175 pregnant women we will test the following three aims: Aim 1: To determine whether a data driven approach to multiple, 1st trimester psychosocial (self- report stress discrimination, social support), lifecourse (hair cortisol, childhood trauma), and biological variables (acute laboratory physiological stress reactivity) generate unique stress profiles that partially explain the racial\u002Fethnic differences in gestational age at birth. Aim 2: To identify molecular indices of mitochondrial and immune functioning in the mother (3x blood draw), placenta, and fetal cord blood that mediate the association between 1st trimester maternal stress phenotypes and risk for earlier gestational age at birth. Aim 3: To evaluate if reduction in stress levels and\u002For improvement in social support over the course of pregnancy is associated with molecular indices of mitochondrial and immune functioning and (exploratory) reduced risk of earlier birth relative to national and hospital norms.\n\nThis new conceptual framing of this adverse health outcome (1) incorporates evidence of the psychosocial factors contributing to risk, (2) aims to account for the racial\u002Fethnic disparities, and (3) harnesses cutting-edge mitochondria knowledge and tools to better characterize PTB's pathophysiology and identify novel targets for its intervention and prevention.",[19,20,21,22],"Preterm Birth","Inflammation","Stress","Mental Health Issue",[],"INTERVENTIONAL","BASIC_SCIENCE",[27],"NA",{"count":29,"type":30},200,"ESTIMATED",[32],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Cognitive Challenge","A cognitive challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation to assess fetal heart rate reactivity in response to maternal acute stress.",[33],[37],{"measure":38,"description":39,"timeFrame":40},"Higher percentage of Black and Hispanic women in high stress group","The high stress group is calculated using various measures including multiple psychosocial, life course, biological variables, and acute stress reactivity to a cognitive challenge (Stroop test).","At 12 - 38 weeks gestation",[42],{"measure":43,"description":44,"timeFrame":45},"Relatively earlier gestational age at birth in high stress group","The high stress phenotype is calculated using various measures including, multiple psychosocial, life course, biological variables, and acute stress reactivity to a cognitive challenge (Stroop test).","At birth, approximately 32 - 42 weeks gestation","FEMALE","18 Years",null,true,{"inclusion":51,"exclusion":56,"raw_text":61},[52,53,54,55],"Pregnant women 18 years of age or older (based on self-report)","Not currently smoking, drinking alcohol, or taking drugs (based on self-report)","Planning to deliver at CUIMC\u002FNYP (based on self-report)","In the first or second trimester of pregnancy (prior to 28 weeks gestation) (based on self-report of estimated date of delivery)",[57,58,59,60],"Multi-fetal pregnancy (based on self-report)","Taking medications regularly that affect the cardiovascular and inflammatory systems, including NSAIDS and other anti-inflammatories, α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2- adrenoceptor agonists) (based on self-report)","This does NOT include baby aspirin or low-dose aspirin, as baby aspirin \u002F low-dose aspirin is not normally considered to be an NSAID.","Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis (based on self-report)","Inclusion Criteria\n\n* Pregnant women 18 years of age or older (based on self-report)\n* Not currently smoking, drinking alcohol, or taking drugs (based on self-report)\n* Planning to deliver at CUIMC\u002FNYP (based on self-report)\n* In the first or second trimester of pregnancy (prior to 28 weeks gestation) (based on self-report of estimated date of delivery)\n\nExclusion Criteria\n\n* Multi-fetal pregnancy (based on self-report)\n* Taking medications regularly that affect the cardiovascular and inflammatory systems, including NSAIDS and other anti-inflammatories, α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2- adrenoceptor agonists) (based on self-report)\n\n  * This does NOT include baby aspirin or low-dose aspirin, as baby aspirin \u002F low-dose aspirin is not normally considered to be an NSAID.\n* Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis (based on self-report)",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":67,"status":8,"city":68,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"Columbia University Irving Medical Center","New York","10032","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Catherine Monk, PhD","CONTACT","917-543-6031","cem31@columbia.edu",{"lat":78,"lon":79},40.71427,-74.00597,[81,84],{"name":73,"role":74,"phone":82,"email":83},"646-774-8941","cem31@cumc.columbia.edu",{"name":85,"role":74,"phone":86,"email":87},"Elizabeth Werner, PhD","646-774-8835","ew150@cumc.columbia.edu",[89],{"name":73,"affiliation":13,"role":90},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":94,"biomarkers":95},[19],[],{"nct_id":4,"found":49,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study planning to enroll 200 pregnant women. The study does not specify if it is randomized or blinded.","completed","Study on Stress and Preterm Birth","This study is looking into how stress and mental health might be connected to preterm birth (when a baby is born too early). Researchers want to understand why preterm birth happens more often in Black and Hispanic women. You could be eligible if you are pregnant, at least 18 years old, not smoking, drinking, or using drugs, and plan to deliver at CUIMC\u002FNYP. You should also be in your first or second trimester of pregnancy. The study will use a Cognitive Challenge (Stroop Color-Word Test) to see how a baby's heart rate reacts to a mother's stress. The main goal is to see if there's a higher percentage of Black and Hispanic women in the high-stress group. The study is currently unclear on its status and plans to enroll 200 participants.","The primary endpoint is measured between 12 and 38 weeks gestation, but long-term follow-up is not specified.",131,"You would participate in a Cognitive Challenge (Stroop Color-Word Test) administered at 36-38 weeks gestation. You would also need to be in your first or second trimester of pregnancy when you join.","Not stated in the trial record.",[33],"v2"]