[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07491510":3,"trial-entities:NCT07491510":83,"trial-summary:NCT07491510":87},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":46,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":68,"locations":70,"central_contacts":79,"overall_officials":80,"references":81,"see_also_links":82},"NCT07491510","STUDY00160319","Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income","Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas","ENROLLING_BY_INVITATION","2026-10-30","2026-07","2026-07-07","2026-03-02","University of Kansas Medical Center","OTHER",false,"The goal of this clinical trial is to learn if a telehealth hypertension group prenatal care program (Centering HER \u002F HGPC-T) can improve blood pressure monitoring and aspirin adherence and help reduce early-onset preeclampsia in low-income, predominantly Black pregnant participants in Kansas who are \\\u003C13 weeks gestation, age ≥18, and moderate or high risk for preeclampsia (USPSTF).\n\nThe main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nDoes Centering HER increase hypertension monitoring and aspirin compliance compared with usual doula care?\n\nIs Centering HER feasible and acceptable, and what contextual factors influence implementation in community clinics?","The study will compare Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB\u002FGYN fellow oversight + Bluetooth BP cuff\u002Fscale ± Apple Watch) to usual doula care + routine prenatal care to see if the intervention improves monitoring\u002Fadherence and supports better BP-related outcomes.\n\nParticipants will:\n\n* Be randomized 2:1 to Centering HER or usual doula care.\n* Complete REDCap surveys at baseline, antepartum, and postpartum.\n* If assigned to Centering HER, attend 7 virtual group sessions and self-monitor\u002Freport BP and weight using a Bluetooth BP cuff\u002Fscale (± Apple Watch), and keep a medication log if applicable.",[19,20],"Monitoring Blood Pressure","Aspirin Prophylaxis",[],"INTERVENTIONAL","PREVENTION",[25],"NA",{"count":27,"type":28},36,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group","routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB\u002FGYN fellow oversight + Bluetooth BP cuff\u002Fscale ± Apple Watch",[35,36],"Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group","usual doula care + routine prenatal care",[38,42],{"measure":39,"description":40,"timeFrame":41},"mean diastolic blood pressure","Average daily diastolic blood pressure","From enrollment to the end of treatment at 12 weeks",{"measure":43,"description":44,"timeFrame":45},"mean systolic blood pressure","Average daily systolic blood pressure","From enrollment of study to end of treatment at 12 weeks",[47,50],{"measure":48,"description":49,"timeFrame":41},"aspirin adherence","average percent of days aspirin was taken",{"measure":51,"description":49,"timeFrame":41},"implementation outcomes","FEMALE","18 Years","45 Years",true,{"inclusion":57,"exclusion":62,"raw_text":67},[58,59,60,61],"English or Spanish speaking","\\\u003C13 weeks gestations","\\>18 years old","moderate or high risk for hypertensive disorders in pregnancy",[63,64,65,66],"less than18 years of age","not receiving prenatal care","not eligible for doula care","no risk factors for hypertensive disorders in pregnancy","Inclusion Criteria:\n\n* English or Spanish speaking\n* \\\u003C13 weeks gestations\n* \\>18 years old\n* moderate or high risk for hypertensive disorders in pregnancy\n\nExclusion Criteria:\n\n* less than18 years of age\n* not receiving prenatal care\n* not eligible for doula care\n* no risk factors for hypertensive disorders in pregnancy",[69],"ADULT",[71],{"facility":13,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Kansas City","Kansas","66101","United States",{"lat":77,"lon":78},39.11417,-94.62746,[],[],[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Early-Onset Preeclampsia",[],{"nct_id":4,"found":55,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study with 36 participants. You would be randomly assigned to either receive Centering HER or usual doula care.","completed","Improving Prenatal Care for Preeclampsia Prevention","This study is looking at a new way to provide prenatal care called Centering HER. It combines regular prenatal care with seven virtual group sessions led by a doula (a trained support person for pregnant individuals) and oversight from an OB\u002FGYN doctor. You would also use a Bluetooth blood pressure cuff and scale at home, and possibly an Apple Watch. The goal is to see if Centering HER helps pregnant individuals monitor their blood pressure and take aspirin as prescribed, which could reduce the risk of early-onset preeclampsia (a serious blood pressure condition during pregnancy). This study is for pregnant individuals who are less than 13 weeks pregnant, aged 18 to 45, speak English or Spanish, and have a moderate or high risk for high blood pressure during pregnancy.","Your blood pressure will be measured from enrollment until the end of treatment at 12 weeks.",129,"If assigned to Centering HER, you would attend 7 virtual group sessions and self-monitor\u002Freport your blood pressure and weight. You would also complete surveys at the beginning, during, and after pregnancy.","Not stated in the trial record.",[],"v2"]