Condition: Bonding · ERAS · Cesarean Section · Sponsor: Okan University
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. Primary Outcome: The primary outcome is the total score on the Postpartum Bonding Questionnaire (PBQ) assessed on postpartum day 7, reflecting mother-infant bonding. Secondary Outcomes: Secondary outcomes include: Maternal/Parental Postnatal Attachment Scale (MIBS) score at 2 hours postpartum (mother) PBQ score at 24 hours postpartum (mother) PBQ score at day 4 postpartum (mother) PBQ score at day 7 postpartum (father-infant bonding) Edinburgh Postnatal Depression Scale (EPDS) scores for mothers at 2 hours and 7 days postpartum Time to initiation of breastfeeding Requirement for neonatal intensive care unit (NICU) admission Sample Size: The 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). Randomization: Participants will be randomized using a block and stratified randomization appr…
This description comes directly from the study's public registry record.
Gökçenur Karakelleoğlu, Assist Prof · +905326702049 · gokcenur.karakelleoglu@okan.edu.tr
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| Istanbul Okan University Hospital | Istanbul, Turkey (Türkiye) | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07276126