protocolSection identificationModule nctId: NCT06261398, orgStudyIdInfo id: 2023H0065, briefTitle: Better Birth Outcomes Through Technology, Education, and Reporting, acronym: BETTER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data., conditionsModule conditions: Pregnancy, conditions: Maternal Anemia, conditions: Pre-Term Birth, conditions: Hypertensive Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 550, type: ESTIMATED, armsInterventionsModule interventions name: BETTER: motivational interviewing and text messaging, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Incidence of maternal anemia, secondaryOutcomes measure: Incidence of Pre-term birth, secondaryOutcomes measure: Incidence of Hypertensive disorders of pregnancy, secondaryOutcomes measure: Incidence of infection, secondaryOutcomes measure: Incidence of Cesarean Delivery, secondaryOutcomes measure: Incidence of Postpartum hemorrhage, secondaryOutcomes measure: Incidence Severe maternal morbidity, secondaryOutcomes measure: Incidence of maternal mortality, secondaryOutcomes measure: Incidence of Small for gestational age birth, secondaryOutcomes measure: Incidence of Large for gestational age, secondaryOutcomes measure: Incidence of NICU admission, secondaryOutcomes measure: Incidence of Perinatal mortality, secondaryOutcomes measure: Incidence of Prenatal care visits, secondaryOutcomes measure: Incidence of Antepartum admission, secondaryOutcomes measure: Length of stay (days), secondaryOutcomes measure: Postpartum re-admission, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Outpatient Care East, status: RECRUITING, city: Columbus, state: Ohio, zip: 43203, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: McCampbell Hall, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: William Grobman, MD, MBA, role: CONTACT, phone: 614-293-4929, email: William.Grobman@osumc.edu, contacts name: Anna Bartholomew, BSN, RN, MPH, role: CONTACT, phone: 614-685-3229, email: Anna.Bartholomew@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False