[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07293741":3,"trial-entities:NCT07293741":113,"trial-summary:NCT07293741":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":59,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":14,"eligibility_criteria":78,"std_ages":89,"locations":91,"central_contacts":106,"overall_officials":110,"references":111,"see_also_links":112},"NCT07293741","2R01NR018837-06","The Impact of Virtual Doula Services on Birth Outcomes in Rural Communities","NOT_YET_RECRUITING","2029-12","2026-07","2026-08-03","2026-09","RAND","OTHER",false,"This study will assess the impact of virtual doula care on birth and postnatal outcomes among rural mothers. The goal of virtual doula services is to improve access to care in underserved communities and decrease urban-rural differences in key maternal health outcomes including mode of birth (cesarean vs vaginal) and birth satisfaction. By implementing a digital randomized controlled trial, the study team will efficiently recruit a national sample of rural pregnant women to provide evidence of the effectiveness of virtual doula care, the appropriateness of virtual visits for different care and support needs, and the role of virtual care in improving maternal health.","Rates of maternal morbidity have been rising in the U.S., and there are stark rural-urban differences in cesarean births and adverse pregnancy outcomes. Increasing access to doula care is a promising strategy to improve maternal health. Doulas are non-clinical providers who offer physical, emotional, and informational support throughout the perinatal period. Yet, despite documented evidence of effectiveness, fewer than 10% of U.S. births involve doulas because of costs and workforce shortages. Virtual doula services may increase access to support in communities that lack doulas and decrease costs; however, there is minimal evidence of the effectiveness of this new care model. Lack of research in general, and randomized controlled trials in particular, represents a significant gap given that virtual doula services are currently offered by numerous organizations, and the states and payers adding doula benefits do not have evidence to inform their telehealth policies.\n\nThe study team will conduct an innovative digital, parallel design randomized controlled trial (RCT) to assess the impact of virtual doula services in rural communities. Primiparous, pregnant women who live in rural zip codes in the U.S. will be recruited. Recruitment will occur via online research panels. Participants will be randomized to scheduled visits with virtual doulas throughout the perinatal period or to usual care. Birth and postnatal outcomes will be captured via surveys and interviews. This study uses mixed methods and aims to assess the impact of virtual doula services on primary outcomes including type of birth (cesarean vs vaginal), birth satisfaction, and parental self-efficacy and secondary outcomes including maternal depression, breastfeeding initiation and duration, and receipt of prenatal and postnatal care. This study will also explore the acceptability of virtual care for different types of doula visits. Together, these aims will inform policy debates about regulation and reimbursement of doula services that incorporate virtual care.",[18,19,20,21],"Birth","Telehealth","Pregnancy","Maternal Health",[23,24,25,26,27,28],"telehealth","virtual","doula","pregnancy","birth","maternal health","INTERVENTIONAL","PREVENTION",[32],"NA",{"count":34,"type":35},614,"ESTIMATED",[37,42],{"type":13,"name":38,"description":39,"armGroupLabels":40},"Virtual doula support","Participants randomized to the intervention arm will receive access to up to 4 scheduled doula visits through Pacify's mobile phone app. All visits will be virtual. Participants may also access the library of resources on the app and text with their doula on demand.",[41],"Virtual Doula Support",{"type":13,"name":43,"description":44,"armGroupLabels":45},"Ebook","Participants will receive an ebook on parenting.",[46],"Active Comparator Arm",[48,52,55],{"measure":49,"description":50,"timeFrame":51},"Birth type","Cesarean or Vaginal Birth","Assessed at 3 weeks postpartum",{"measure":53,"description":54,"timeFrame":51},"Birth Satisfaction","Score on Birth Satisfaction Scale-Revised. Scores can range from 0-40, with higher scores indicating greater satisfaction.",{"measure":56,"description":57,"timeFrame":58},"Parental Self-Efficacy","Score on maternal confidence questionnaire. Scores can range from 14 to 70, with higher scores indicating greater maternal confidence.","Assessed at 12 weeks postpartum",[60,63,66,69,72],{"measure":61,"description":62,"timeFrame":51},"Maternal Depression","Score on Edinburgh Depression Scale. Minimum score of 0 and maximum score of 27, with higher scores indicating increased severity of depressive symptoms.",{"measure":64,"description":65,"timeFrame":58},"Breastfeeding duration","Any breastfeeding (yes\u002Fno) in prior 7 days",{"measure":67,"description":68,"timeFrame":58},"Receipt of postnatal care","Attendance at postpartum visit",{"measure":70,"description":71,"timeFrame":51},"Birth Truma","Traumatic birth experience (yes\u002Fno)",{"measure":73,"description":74,"timeFrame":58},"Breastfeeding Initiation","Attempted breastfeeding (yes\u002Fno)","FEMALE","18 Years","45 Years",{"inclusion":79,"exclusion":83,"raw_text":88},[80,81,82],"18-45 years of age","pregnant (second or early third trimester) with their first child","reside in a rural zip codes in the U.S.",[84,85,86,87],"non-singleton pregnancy","police custody or incarceration","infant to be separated from mother (e.g., placed for adoption, protective custody)","working with a doula prior to enrollment.","Inclusion Criteria:\n\n* 18-45 years of age\n* pregnant (second or early third trimester) with their first child\n* reside in a rural zip codes in the U.S.\n\nExclusion Criteria:\n\n* non-singleton pregnancy\n* police custody or incarceration\n* infant to be separated from mother (e.g., placed for adoption, protective custody)\n* working with a doula prior to enrollment.",[90],"ADULT",[92],{"facility":12,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"Arlington","Virginia","22202","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"RAND Washington Office","CONTACT","703-413-1100","Health@rand.org",{"lat":104,"lon":105},38.88101,-77.10428,[107],{"name":108,"role":100,"phone":101,"email":109},"Lori Uscher-Pines, PhD","luscherp@rand.org",[],[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[20],[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study where participants will be randomly assigned to either receive virtual doula support or an ebook. It aims to enroll 614 participants.","completed","Virtual Doula Services for Rural Pregnant Women","This study is looking at how virtual doula support might help pregnant women in rural areas. Doulas are people who offer physical, emotional, and informational support during pregnancy and after birth. You would receive access to up to 4 virtual doula visits through a mobile app, along with resources and the ability to text your doula. Another group will receive an ebook about parenting. The researchers want to see if virtual doula services can improve birth outcomes, like the type of birth (vaginal or C-section) and how satisfied mothers are with their birth experience. They are also looking at how confident new parents feel. To join, you need to be a woman between 18 and 45 years old, pregnant with your first child, and live in a rural area of the U.S. The study aims to enroll 614 participants, but its current status is unclear.","Birth type and satisfaction will be assessed at 3 weeks postpartum. Parental self-efficacy will be assessed at 12 weeks postpartum.",145,"If you receive virtual doula support, you will have access to up to 4 scheduled virtual doula visits, an app with resources, and text messaging with your doula. If you receive the ebook, you will get an ebook on parenting.","Not stated in the trial record.",[38,43],"v2"]