[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06718907":3,"trial-entities:NCT06718907":83,"trial-summary:NCT06718907":86},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":57,"locations":59,"central_contacts":74,"overall_officials":78,"references":81,"see_also_links":82},"NCT06718907","NSU 2023-231","Mitigating Response to Stressors in Pregnant Women","Mitigating Response to Stressors in the Pregnant Woman","RECRUITING","2026-12-31","2026-02","2026-02-25","2024-12-20","Nova Southeastern University","OTHER",false,"Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.","Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.",[19],"Pregnancy",[21],"stressors, chronic stress, pregnancy, stress regulation, stress management","INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Simulated stimuli","Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.",[35],"Stress Exposure and Management",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Stress Management","Participants will practice stress management and stress reduction at home, independently.",[35],[41],{"measure":42,"description":43,"timeFrame":44},"Stress level change","change in stress measures as assessed by salivary cortisol levels from collected saliva before and after practicing stress management techniques. Cortisol levels are measured in ug\u002FdL.","4-8 weeks",[],"FEMALE","21 Years","37 Years",true,{"inclusion":51,"exclusion":53,"raw_text":56},[52],"between 21 and 37 years of age",[54,55],"in less than 24 weeks gestation","high risk pregnancies","Inclusion Criteria: in 24 weeks gestation or more\n\n* between 21 and 37 years of age\n\nExclusion Criteria:\n\n* in less than 24 weeks gestation\n* high risk pregnancies",[58],"ADULT",[60],{"facility":13,"status":8,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":71},"Davie","Florida","33314","United States",[66],{"name":67,"role":68,"phone":69,"email":70},"Gesulla Cavanaugh, PhD, MPH, MS","CONTACT","954-262-1980","gcavanaugh@nova.edu",{"lat":72,"lon":73},26.06287,-80.2331,[75],{"name":76,"role":68,"phone":77,"email":70},"Gesulla Cavanaugh, PhD, MS, MPH","9542621980",[79],{"name":67,"affiliation":13,"role":80},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":85},[19],[],{"nct_id":4,"found":49,"summary":87,"prompt_version":97},{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.","completed","Mitigating Stress in Pregnant Women Study","This study is looking at ways to help pregnant women manage stress. It will involve exposing participants to a video to see how their bodies react to stress and relaxation. You will also practice stress management techniques at home. The goal is to understand how stress affects pregnant women and how it can be reduced, especially for those who experience a lot of stress. We're looking for women between 21 and 37 years old who are at least 24 weeks pregnant. The main goal is to see how stress levels change over 4 to 8 weeks. The study is currently recruiting 50 participants, but its overall status is unclear.","Stress levels will be measured at 4-8 weeks after the intervention begins.",109,"You will be exposed to video stimuli and practice stress management at home independently. Your stress levels will be measured between 4 and 8 weeks.","Not stated in the trial record.",[37],"v2"]