[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Lund University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention: Cesarean Bundle","ACTIVE_COMPARATOR","Cesarean Bundle (structured discussion guide, mandatory second\u002Fteam opinion, and regular team reviews\u002Faudits)",[13],"Other: Cesarean Bundle",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Standard care (usual clinical practice without structured tools)",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Cesarean Bundle","The Cesarean Bundle is a structured, three-component clinical intervention designed to support evidence-based and shared decision-making for planned cesarean sections:\n\n1. Cesarean Discussion Guide:\n\n   A standardized decision-support tool used during all consultations for planned cesarean section. It incorporates clinical data, risk stratification (e.g., Robson classification), and clear information on short- and long-term risks and benefits of cesarean versus vaginal birth, while also capturing patient preferences and values.\n2. Mandatory Second\u002Fteam Opinion:\n\n   All requests for planned cesarean section require review and approval by a second clinician\u002Fteam before a final decision is made.\n3. Regularl Multidisciplinary Team Meetings:\n\nRegular team-based reviews of cases and decision-making patterns to promote consistency, reflection, and adherence to evidence-based practice.\n\nThe intervention is integrated into routine care, with minimal disruption to standard workflows, and is support",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Mehreen Zaigham, PhD, MBBS","CONTACT","+46 40 331000","mehreen.zaigham@med.lu.se",[31],{"facility":32,"status":33,"city":34,"state":18,"zip":18,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Skånes university hospital","RECRUITING","Malmö","Sweden","SE",{"type":38,"coordinates":39},"Point",[40,41],13.00073,55.60587,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":46,"phoneExt":18,"email":29},"Mehreen Zaigham","+46 40 33 10 00",{"type":48,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[50],{"name":51,"class":6},"Skane University Hospital","100651487","the-cesarean-study-optimizing-cesarean-sections-and-improving-patient-healthcare-provider-trust-using-evidence-informed-recommendations-100651487",false,"NCT07759622","The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations","The Cesarean Study","CS","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years\n* Referred for consultation regarding planned cesarean section\n* Able to provide informed consent (with interpreter support if needed)\n\nExclusion Criteria:\n\n* Women with an absolute medical indication for cesarean section (e.g., placenta previa), where shared decision-making is not applicable\n* Women who decline participation in the study components (e.g., surveys\u002Finterviews)",true,"FEMALE","18 Years",{"count":64,"type":65},260,"ESTIMATED","INTERVENTIONAL",[68],"NA","Cesarean section (CS) rates have rapidly increased worldwide, with projections suggesting that by 2030, one in every three births will be by CS (1). In Sweden, rates have more than doubled from 9% in the 1990s, to 20% in 2024 (2). While CS can be a life-saving procedure when medically indicated, non-essential CS increase the risk of complications and have been linked to increased maternal morbidity and even death, neonatal respiratory issues, and longer recovery times (3). They also place added strain on already burdened healthcare systems by increasing the use of medical resources and staff capacity.\n\nThe purpose of this project is to evaluate the use of the \"Cesarean Bundle\", a three-part intervention designed to improve patient-clinician communication and trust.\n\nPrimary Aim: To evaluate the impact of the \"Cesarean Bundle\" in improving patient-clinician communication and trust compared to standard care.\n\nHypothesis: Use of the \"Cesarean Bundle\" will improve patients' trust in their healthcare providers.\n\nSecondary Aim: To evaluate whether adoption of the \"Cesarean Bundle\" is associated with changes in cesarean section rates, especially among low-risk obstetric populations.\n\nHypothesis: Implementation of the \"Cesarean Bundle\" will be associated with a reduction in overall cesarean section rates, particularly among low-risk pregnancies.",[71],"Cesarean Birth",[73,74,21,75,76,77,78,79,80,81,82,83,84,85,86],"Cesarean Section","Planned Cesarean","Decision Support Tool","Shared Decision-Making","Patient-Clinician Communication","Patient Trust","Maternal Outcomes","Neonatal Outcomes","Pregnancy","Obstetrics","Vaginal Birth","Robson Classification","Implementation Science","Health Care Quality Improvement","2026-08-06",{"date":89,"type":90},"2026-08-12","ACTUAL",{"date":92,"type":90},"2026-05-05",{"date":94,"type":65},"2035-12-31",{"name":5,"class":6},1]