NCT07276126 The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
| NCT ID | NCT07276126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Okan University |
| Condition | Bonding |
| Study Type | INTERVENTIONAL |
| Enrollment | 1 participants |
| Start Date | 2025-12-13 |
| Primary Completion | 2026-02-20 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1 participants in total. It began in 2025-12-13 with a primary completion date of 2026-02-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 approach based on parity (primiparous vs multiparous) and planned type of anesthesia. Blinding (Masking): Due 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. Study Timeline and Visits: Participants 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. Significance and Rationale: The 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. Key Features: Multicenter, randomized controlled design Parallel 1:1 allocation Stratified randomization by parity and anesthesia type Blinded outcome assessment and data analysis Multiple postpartum evaluation points Focus on psychosocial and clinical outcomes Expected Contributions: This 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.
Eligibility Criteria
IInclusion Criteria: Pregnant women aged 18-60 years. Singleton, live fetus, and ≥37 weeks of gestation. Undergoing elective or medically indicated cesarean delivery. Ability to read and understand Turkish (for questionnaire validity). Mothers and fathers willing and able to complete postpartum follow-up assessments (2 hours, 24 hours, day 4, day 7). Provision of written informed consent by mother and, if participating, by father/partner. Maternal postpartum clinical stability (no condition precluding questionnaire completion). ❌ Exclusion Criteria (Dışlanma Kriterleri) Exclusion Criteria: Preterm birth (\<37 weeks) or multiple gestation (twins, triplets). Stillbirth, early neonatal death, or major congenital anomaly. Newborn requiring prolonged NICU stay preventing bonding assessments. Maternal severe obstetric complications: Massive postpartum hemorrhage Hysterectomy Severe preeclampsia or eclampsia Severe postpartum infection Maternal active psychiatric disorder or use of psychotropic medication. Maternal need for high-dose opioid analgesia or sedation interfering with bonding assessments. Inability to read/understand Turkish or cognitive impairment preventing questionnaire completion. Failure to complete follow-up visits (2 hours, 24 hours, day 4, day 7). Withdrawal of consent at any time.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07276126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Bonding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07276126 currently recruiting?
Yes, NCT07276126 is actively recruiting participants. Contact the research team at gokcenur.karakelleoglu@okan.edu.tr for enrollment information.
Where is the NCT07276126 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07276126 clinical trial?
NCT07276126 is sponsored by Okan University. The trial plans to enroll 1 participants.