[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614171":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":24,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":81,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":68},{"fullName":5,"class":6},"Okan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ERAS Protocol","ACTIVE_COMPARATOR","Participants in this arm will receive the Enhanced Recovery After Cesarean (ERAS) protocol, which includes preoperative patient education and anxiety reduction, intraoperative multimodal analgesia, early oral intake, early mobilization, and early removal of Foley catheter. Skin-to-skin contact and early breastfeeding will be encouraged, and fathers will be actively involved in postpartum care. Outcomes include mother-infant and father-infant bonding, maternal postpartum depression, breastfeeding initiation, neonatal adaptation, and maternal clinical recovery.",[13],"Behavioral: ERAS Protocol",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard Perioperative Care","Participants in this arm will receive standard perioperative care for cesarean delivery, which includes routine preoperative preparation, conventional intraoperative anesthesia and analgesia, standard postoperative monitoring, and usual mobilization and oral intake schedules. Skin-to-skin contact and breastfeeding initiation will be performed according to standard hospital practice, without additional ERAS-specific interventions. Outcomes include mother-infant and father-infant bonding, maternal postpartum depression, breastfeeding initiation, neonatal adaptation, and maternal clinical recovery.",[18],"Behavioral: Standard Perioperative Care",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","The Enhanced Recovery After Cesarean (ERAS) protocol includes shortened preoperative fasting, preoperative carbohydrate loading, multimodal opioid-sparing analgesia, early oral intake, early ambulation, and early removal of urinary catheter. The protocol also incorporates immediate or early skin-to-skin contact, early initiation of breastfeeding, and structured parental involvement. ERAS aims to optimize maternal postoperative recovery, reduce analgesic requirements, enhance mobility, improve patient satisfaction, and support early maternal-infant and paternal-infant bonding. No surgical technique is altered; only perioperative care differs from usual practice.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Standard perioperative cesarean care includes routine preoperative fasting, no carbohydrate loading, conventional postoperative analgesia, delayed oral intake, delayed ambulation, and routine timing of urinary catheter removal. Immediate skin-to-skin contact and early breastfeeding are not systematically implemented. This arm reflects current institutional usual care and serves as the comparator to the ERAS protocol. No deviation from standard surgical or anesthetic techniques is introduced.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Gökçenur Karakelleoğlu, Assist Prof","CONTACT","+905326702049","gokcenur.karakelleoglu@okan.edu.tr",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":39,"country":40,"countryCode":24,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Istanbul Okan University Hospital","RECRUITING","Istanbul","34947","Turkey (Türkiye)",{"type":42,"coordinates":43},"Point",[44,45],28.94966,41.01384,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":50,"phoneExt":24,"email":51},"Ceren Kırımlı Yanık, MD","+905334109110","elif.kirimli@okan.edu.tr",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Gökçenur Karakelleoğlu","Assisted Prof","100614171","the-effect-of-the-cesarean-eras-protocol-on-mother-infant-and-father-infant-bonding-a-multicenter-randomized-controlled-clinical-trial-100614171",false,"NCT07276126","The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.","ERAS-CS-BOND-1","IInclusion Criteria:\n\nPregnant women aged 18-60 years.\n\nSingleton, live fetus, and ≥37 weeks of gestation.\n\nUndergoing elective or medically indicated cesarean delivery.\n\nAbility to read and understand Turkish (for questionnaire validity).\n\nMothers and fathers willing and able to complete postpartum follow-up assessments (2 hours, 24 hours, day 4, day 7).\n\nProvision of written informed consent by mother and, if participating, by father\u002Fpartner.\n\nMaternal postpartum clinical stability (no condition precluding questionnaire completion).\n\n❌ Exclusion Criteria (Dışlanma Kriterleri)\n\nExclusion Criteria:\n\nPreterm birth (\\\u003C37 weeks) or multiple gestation (twins, triplets).\n\nStillbirth, early neonatal death, or major congenital anomaly.\n\nNewborn requiring prolonged NICU stay preventing bonding assessments.\n\nMaternal severe obstetric complications:\n\nMassive postpartum hemorrhage\n\nHysterectomy\n\nSevere preeclampsia or eclampsia\n\nSevere postpartum infection\n\nMaternal active psychiatric disorder or use of psychotropic medication.\n\nMaternal need for high-dose opioid analgesia or sedation interfering with bonding assessments.\n\nInability to read\u002Funderstand Turkish or cognitive impairment preventing questionnaire completion.\n\nFailure to complete follow-up visits (2 hours, 24 hours, day 4, day 7).\n\nWithdrawal of consent at any time.",true,"ALL","18 Years","60 Years",{"count":68,"type":69},1,"ESTIMATED","INTERVENTIONAL",[72],"NA","This is a multicenter, 1:1 parallel-group, randomized controlled trial designed to compare the effect of the Enhanced Recovery After Cesarean (ERAS) protocol versus standard perioperative care on mother-infant and father-infant bonding in women undergoing cesarean delivery. The study will initially be conducted as a single-center trial at Istanbul Okan University Hospital. Once adequate site preparation is completed, additional centers will be added to expand the study to a multicenter setting.\n\nPrimary Outcome:\n\nThe primary outcome is the total score on the Postpartum Bonding Questionnaire (PBQ) assessed on postpartum day 7, reflecting mother-infant bonding.\n\nSecondary Outcomes:\n\nSecondary outcomes include:\n\nMaternal\u002FParental Postnatal Attachment Scale (MIBS) score at 2 hours postpartum (mother)\n\nPBQ score at 24 hours postpartum (mother)\n\nPBQ score at day 4 postpartum (mother)\n\nPBQ score at day 7 postpartum (father-infant bonding)\n\nEdinburgh Postnatal Depression Scale (EPDS) scores for mothers at 2 hours and 7 days postpartum\n\nTime to initiation of breastfeeding\n\nRequirement for neonatal intensive care unit (NICU) admission\n\nSample Size:\n\nThe total multicenter target sample size is n=300, with 150 participants in the ERAS group and 150 in the standard care group. The initial single-center phase at Okan University Hospital will enroll a target of n=100 participants (50 per group).\n\nRandomization:\n\nParticipants will be randomized using a block and stratified randomization approach based on parity (primiparous vs multiparous) and planned type of anesthesia.\n\nBlinding (Masking):\n\nDue to the nature of the intervention, care providers cannot be blinded to group assignment. However, outcome assessors and data analysts will remain blinded to treatment allocation to minimize bias.\n\nStudy Timeline and Visits:\n\nParticipants will be evaluated at multiple time points following cesarean delivery: 2 hours postpartum, 24 hours postpartum, day 4 postpartum, and day 7 postpartum. All primary and secondary outcomes will be collected at the specified time points.\n\nSignificance and Rationale:\n\nThe ERAS protocol for cesarean delivery is designed to optimize perioperative care, enhance recovery, and potentially improve early parent-infant bonding. While previous studies have focused on maternal recovery and clinical outcomes, evidence regarding the impact of ERAS on both mother-infant and father-infant bonding remains limited. This trial aims to provide high-quality evidence on whether ERAS implementation can improve early bonding experiences, maternal mental health, breastfeeding initiation, and neonatal outcomes compared with standard perioperative care. The findings may guide future clinical practice and contribute to optimizing family-centered care in cesarean deliveries.\n\nKey Features:\n\nMulticenter, randomized controlled design\n\nParallel 1:1 allocation\n\nStratified randomization by parity and anesthesia type\n\nBlinded outcome assessment and data analysis\n\nMultiple postpartum evaluation points\n\nFocus on psychosocial and clinical outcomes\n\nExpected Contributions:\n\nThis study will provide comprehensive data on the feasibility and effectiveness of ERAS protocols in cesarean deliveries and their potential benefits for both maternal and paternal bonding with the newborn. The inclusion of both mother-infant and father-infant outcomes, as well as maternal mental health and breastfeeding indicators, ensures a holistic assessment of early family-centered outcomes.",[75,76,77,78,79,80],"Bonding","ERAS","Cesarean Section","Maternal Care","Father - Child Relations","Mother-Infant Interaction",[82,83,84,85,86],"eras","erac","cesarean","maternal bonding","paternal bonding","2026-04-27",{"date":89,"type":90},"2026-04-28","ACTUAL",{"date":92,"type":90},"2025-12-13",{"date":94,"type":69},"2026-04-20",{"name":5,"class":6}]