[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601992":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Consent for Possible Cesarean Delivery","EXPERIMENTAL","Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery upon arrival to labor and delivery for the start of their induction of labor.",[13],"Other: Early Surgical Consent",{"label":15,"type":16,"description":17,"interventionNames":18},"Indicated Consent for Possible Cesarean Delivery","ACTIVE_COMPARATOR","Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery only if it appears to be clinically indicated throughout their induction of labor.",[19],"Other: Surgical Consent if Clinically Indicated",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Early Surgical Consent","Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Surgical Consent if Clinically Indicated","Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Rebecca Beal","Duke University Department of Obstetrics and Gynecology","STUDY_DIRECTOR",{"name":36,"affiliation":5,"role":34},"Kristin Weaver",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Sarahn Wheeler, MD, MHSc","CONTACT","919-681-5220","Sarahn.wheeler@duke.edu",{"name":44,"role":40,"phone":25,"phoneExt":25,"email":45},"Kelsey McNew, MD, PhD","kelsey.mcnew@duke.edu",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Durham","North Carolina","27705","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.89862,35.99403,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":25,"email":64},"Sarahn Wheeler","9196815220","sarahn.wheeler@duke.edu",{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100601992","optimizing-timing-of-cesarean-delivery-consent-on-labor-and-delivery-100601992",false,"NCT07117708","Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery","The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery","Inclusion Criteria:\n\n* 18 years of age or older\n* Receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates\n* Between 34 weeks 0 days and 41 weeks 0 days of gestation\n* Scheduled for induction of labor OR are eligible\u002Fintend to be scheduled for an induction of labor\n\nExclusion Criteria:\n\n* Trial of labor after cesarean delivery\n* Multiple gestation\n* Major fetal anomalies\n* Presenting for induction of labor as a transfer from the antepartum inpatient service\n* Non-English speaking\n* Those who do not intend to labor\n* Patients who are ineligible for vaginal delivery for other reasons, including fetal malpresentation or abnormal placentation","FEMALE","18 Years",{"count":77,"type":78},200,"ESTIMATED","INTERVENTIONAL",[81],"NA","Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated.\n\nThis study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.",[84,85],"Pregnancy","Informed Consent",[87,88],"pregnancy","informed consent","2026-04-22",{"date":91,"type":92},"2026-04-23","ACTUAL",{"date":94,"type":92},"2025-08-27",{"date":96,"type":78},"2027-05",{"name":5,"class":6},1]