[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653436":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":11,"armGroups":52,"interventions":63,"overallOfficials":11,"centralContacts":11,"locations":69,"responsibleParty":89,"collaborators":93,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":122,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"University of South Carolina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Rate of receipt of postpartum care within 2 weeks of delivery",null,"From delivery of infant(s) to 2 weeks postpartum",{"measure":14,"description":11,"timeFrame":15},"Rate of receipt of postpartum care within 6 weeks of delivery","From delivery of infant(s) to 6 weeks postpartum",[17,19,22,26,29,31,33,37,40,42],{"measure":18,"description":11,"timeFrame":15},"Time to receipt of postpartum care visit within 6 weeks postpartum",{"measure":20,"description":11,"timeFrame":21},"Number of outpatient visits within 6 months postpartum","From delivery of infant(s) to 6 months postpartum",{"measure":23,"description":24,"timeFrame":25},"Rate of postpartum depression at 6 months postpartum","Measured using the Edinburgh Postnatal Depression Scale (EPDS)","At 6 months postpartum",{"measure":27,"description":28,"timeFrame":25},"Rate of post-traumatic stress disorder (PTSD) symptoms at 6 months postpartum","Measured using the PTSD Checklist for DSM-5 (PCL-5)",{"measure":30,"description":11,"timeFrame":25},"Rate of milk expression\u002Fbreastfeeding initiation",{"measure":32,"description":11,"timeFrame":25},"Duration of exclusive breastfeeding",{"measure":34,"description":35,"timeFrame":36},"Rate of treatment for iron deficiency anemia in the intervention group","Participants whose last hemoglobin (Hb) measurement during the delivery hospitalization was \\\u003C10 g\u002FdL will undergo repeat Hb assessment at approximately 2 weeks postpartum. Participants with a postpartum Hb \\\u003C9 g\u002FdL will undergo iron studies to evaluate for iron deficiency. Management of iron deficiency anemia, including oral or intravenous iron therapy as clinically indicated, will be provided in accordance with current clinical guidelines and the treating clinician's judgment.","From delivery of infant(s) up to 6 weeks postpartum",{"measure":38,"description":11,"timeFrame":39},"Rate of emergency department visits within 12 months postpartum","At 1 year postpartum",{"measure":41,"description":11,"timeFrame":39},"Rate of postpartum readmissions within 12 months postpartum",{"measure":43,"description":11,"timeFrame":44},"Average daily expressed breastmilk volume in the NICU in the first 7, 14, or 28 days","7, 14, 28 days",{"allocation":46,"interventionModel":47,"interventionModelDescription":11,"primaryPurpose":48,"observationalModel":11,"timePerspective":11,"maskingInfo":49},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":50,"maskingDescription":11,"whoMasked":11},"NONE","This study will employ a randomized controlled trial design. Participants will be recruited from Prisma Health Richland Hospital and may be enrolled during late pregnancy (including individuals on bed rest), in a postpartum unit, or while their infant is admitted to the NICU. Inclusion criteria will be English speaking individuals ≥18 years old on Medicaid insurance, who delivered a baby \\\u003C34 weeks' gestation, and whose baby will be admitted to the NICU. The control arm of the trial will receive standard postpartum care, while the intervention arm will receive nurse-midwife postpartum care and doula-coordinated postpartum care, mental health screening and referral, and screening and treatment for iron deficiency anemia.",[53,57],{"label":54,"type":55,"description":56,"interventionNames":11},"Control","NO_INTERVENTION","Participants will receive routine postpartum care by their regular OB provider office and will fill remotely questionnaires at 6 months regarding mental health and breastfeeding practices.",{"label":58,"type":59,"description":60,"interventionNames":61},"Intervention","EXPERIMENTAL","Participants will receive at least weekly doula support while their newborn(s)\u002F infant(s) is\u002Fare admitted in the NICU, for a minimum of 3 visits. Participants will have the option to receive routine postpartum care through by their regular OB provider office or by the nurse and nurse-midwife associated with the study on NICU premises. They will remotely fill a mental health questionnaire at 3 months and questionnaires at 6 months regarding breastfeeding practices and satisfaction with the program.",[62],"Behavioral: Doula-coordinated, Midwife-delivered postpartum care",[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"BEHAVIORAL","Doula-coordinated, Midwife-delivered postpartum care","Doulas offer continuous emotional and physical support, which can help reduce stress and improve mental health outcomes. Nurse-midwives bring specialized knowledge in maternal and newborn care, ensuring that medical and psychosocial needs are addressed holistically. Together, doulas and midwives can enhance the quality of postpartum care, promote maternal well-being, and potentially reduce the incidence of SMM and mortality. This integrated approach can also facilitate better coordination of care and support for birthing individuals.",[58],[70],{"facility":71,"status":11,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Prisma Health Richland","Columbia","South Carolina","29203","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-81.03481,34.00071,{"lat":81,"lon":80},[84],{"name":85,"role":86,"phone":87,"phoneExt":11,"email":88},"Research Nurse","CONTACT","803-687-9974","gwendoline.helin-milgrom@prismahealth.org",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Nansi Boghossian","Associate Professor",[94],{"name":95,"class":6},"Prisma Health-Midlands","100653436","the-goal-is-to-examine-the-impact-of-doula-coordinated-midwife-delivered-postpartum-care-among-individuals-with-preterm-births-34-weeks-gestation-requiring-nicu-admission-100653436",false,"NCT07787845","The Goal is to Examine the Impact of Doula-coordinated, Midwife-delivered Postpartum Care Among Individuals With Preterm Births \u003C34 Weeks' Gestation Requiring NICU Admission.","Nurturing, Empowering, Supporting Together (NEST): a Project to Improve Postpartum Birth Outcomes in the NICU.","NEST","Inclusion Criteria:\n\n* Age above 18 at time of delivery of infant\n* English-speaking\n* Medicaid insurance coverage at the time of delivery, either as primary or secondary coverage\n* Delivery before 34 weeks' gestation\n* Infant admitted to the NICU, 10 days old or less\n\nExclusion Criteria:\n\n* Stillbirth\n* Infant death in the delivery room\n* Infant with severe congenital anomalies expected to result in death shortly after birth\n* Inability to provide informed consent\n* Inability to visit the infant in the NICU at least once per week\n* More than 10 days postpartum","FEMALE","18 Years",{"count":107,"type":108},350,"ESTIMATED","INTERVENTIONAL",[111],"NA","The primary objective of this research is to conduct a randomized clinical trial to examine the impact of doula-coordinated, midwife-delivered postpartum care (intervention arm) on postpartum health care utilization, health outcomes, and patient-reported experiences compared with standard postpartum care (control arm) among individuals with preterm births \\\u003C34 weeks' gestation requiring neonatal intensive care unit (NICU) admission.",[114,115,116,117],"Doula Support","Postpartum","Postpartum Anaemia","Postpartum Depression (PPD)",[119,120,121],"preterm","doula support","mental health","NOT_YET_RECRUITING","2026-08-22",{"date":125,"type":126},"2026-08-26","ACTUAL",{"date":128,"type":108},"2026-09",{"date":130,"type":108},"2030-08",{"name":5,"class":6},1]