[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"maternal-care\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:maternal-care":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100556090","holistic-care-partner-program-feasibility-and-acceptability-100556090",false,"NCT06520566","Holistic Care Partner Program Feasibility and Acceptability","Holistic Care Partners: A Black Woman-led Nurse Navigation Program to Improve Care, Reduce Harm, and Enhance Perinatal Wellbeing for Black Birthing People","Inclusion Criteria:\n\n1. Identify as Black or within the Black\u002FAfrican Diaspora\n2. Enrolled in the HCP program while pregnant or within 6 weeks postpartum\n3. Enrolled in the Faculty Group Practice at NYU Langone Health (NYULH) for obstetric care\n4. Plan to give birth at NYULH Tisch or gave birth at NYULH Tisch if postpartum at screening.\n5. Comfortable reading and\u002For speaking English (approximately 95% of Black women speak English)\n6. Are 18 years or older\n\nExclusion Criteria:\n\n1. Does not identify as Black or within the Black\u002FAfrican Diaspora\n2. Did not enroll in the HCP program while pregnant or within 6 weeks postpartum.\n3. Not enrolled in the FGP NYULH for obstetric care\n4. Does not plan to give birth at NYULH Tisch or did not give birth at NYULH Tisch if postpartum at time of screening.\n5. Is not 18 years or older\n6. Multiple gestation\n7. Significant fetal anomaly requiring exceptional care",true,"FEMALE","18 Years",{"count":20,"type":21},55,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study aims to build on the knowledge of the United States' ongoing maternal health crisis for Black birthing people. The study team will take a holistic focused approach to build on the experiences of Black women perinatal nurses, Black women\u002Fbirthing people, and their care partners enrolled in the Holistic Care Partner Program (HCP) to understand the program's feasibility and acceptability. HCP was developed at NYU Langone Health by Blank women-led perinatal nurses to address the effects of obstetric racism and the associated fear of pregnancy and birth faced by Black women and birthing people. Utilizing a mixed-methods approach, the study will focus on understanding HCP's acceptability and feasibility via surveys and qualitative interviews with Black women and birthing people and their partners\u002Fsupport persons to identify strategies and recommendations for intervention improvement. Exploratory analysis of maternal and infant outcomes will be conducted using a propensity score matched historical control group.",[27],"Maternal Care","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2024-07-15",{"date":36,"type":21},"2026-08-18",{"name":38,"class":39},"NYU Langone Health","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":48,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":40},"100614171","the-effect-of-the-cesarean-eras-protocol-on-mother-infant-and-father-infant-bonding-a-multicenter-randomized-controlled-clinical-trial-100614171","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.","ALL","60 Years",{"count":40,"type":21},[24],"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.",[54,55,56,27,57,58],"Bonding","ERAS","Cesarean Section","Father - Child Relations","Mother-Infant Interaction",[60,61,62,63,64],"eras","erac","cesarean","maternal bonding","paternal bonding","2026-04-27",{"date":67,"type":32},"2026-04-28",{"date":69,"type":32},"2025-12-13",{"date":71,"type":21},"2026-04-20",{"name":73,"class":39},"Okan University"]