The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Phase: NA
Conditions: Bonding, ERAS, Cesarean Section, Maternal Care, Father - Child Relations, Mother-Infant Interaction
Sponsor: Okan University

STUDY PROTOCOL 
COVER PAGE 
STUDY PROTOCOL 
Title: Effect of Enhanced Recovery After Cesarean (ERAS) Protocol on Mother–Infant and 
Father–Infant Bonding: A Multicenter Randomized Controlled Trial 
Protocol Code: ERAS-CS-BOND-1 
Principal Investigator: Dr. Gökçenur Karakelleoğlu 
Institution: Istanbul Okan University Hospital 
Country: Türkiye 
Version: 1.0 
Date: November 04, 2025 
NCT Number: Not yet Assigned  
 
1. STUDY SUMMARY 
This multicenter, parallel-group, randomized controlled trial will compare the effect of 
Enhanced Recovery After Cesarean (ERAS) protocol versus standard perioperative care on 
mother–infant and father–infant bonding among women undergoing cesarean delivery. 
Initially, the study will begin at Istanbul Okan University Hospital, with additional centers 
joining after initial feasibility. 
 
Primary Outcome: Postpartum Bonding Questionnaire (PBQ) total score on 
postpartum day 7 (mother–infant bonding). 
 
Secondary Outcomes: 
o Maternal bonding: MIBS (2 hours), PBQ (24 hours, day 4, day 7) 
o Father–infant bonding: PBQ (day 7) 
o Maternal depressive symptoms: EPDS (2 hours, day 7) 
o Time to first breastfeeding, duration of skin-to-skin contact 
o Neonatal outcomes: NICU admission, Apgar scores 
o Maternal recovery: oral intake, mobilization time, analgesic needs, length of 
stay 

Sample size: 300 mothers (150 ERAS, 150 standard care) and 300 fathers (optional 
participation). 
Randomization: Block randomization, stratified by parity and anesthesia type. 
Blinding: Outcome assessors and data analysts will be blinded. 
 
2. BACKGROUND AND RATIONALE 
Cesarean delivery rates continue to rise globally. ERAS, originally developed for colorectal 
surgery, has been adapted for obstetrics to enhance recovery, reduce opioid use, encourage 
early mobilization, shorten hospital stay, and improve patient satisfaction. 
Evidence suggests that early skin-to-skin contact and early breastfeeding support mother–
infant bonding and reduce postpartum depressive symptoms. Delays in mobilization, 
prolonged fasting, and opioid-heavy pain management can negatively affect maternal mood 
and bonding. 
Father–infant bonding has been rarely studied, especially in the context of cesarean delivery, 
where paternal involvement may be limited. 
To date, no randomized controlled trial in Türkiye has examined ERAS effects on both 
maternal and paternal bonding. This study aims to fill this gap. 
 
3. STUDY OBJECTIVES 
Primary Objective 
To determine whether the ERAS protocol improves mother–infant bonding on postpartum day 
7 compared with standard care. 
Secondary Objectives 
 
Evaluate the impact of ERAS on father–infant bonding at day 7 
 
Assess early maternal bonding (MIBS at 2 hours; PBQ at 24 hours, day 4, day 7) 
 
Evaluate postpartum depressive symptoms (EPDS at 2 hours and day 7) 

 
Compare neonatal outcomes (NICU need, Apgar scores) 
 
Compare maternal recovery indicators (oral intake, ambulation, analgesia, length of 
stay) 
 
Evaluate maternal childbirth satisfaction and perceived self-efficacy 
 
4. STUDY POPULATION 
Inclusion Criteria 
1. Women aged 18–50 years 
2. Singleton, live fetus at ≥37 weeks 
3. Elective or emergency cesarean delivery 
4. Ability to read/understand Turkish 
5. Willingness to complete follow-up assessments 
6. Written informed consent from mother (and father, if participating) 
7. Clinically stable postpartum condition 
Exclusion Criteria 
1. Preterm birth (<37 weeks) 
2. Multiple pregnancy 
3. Stillbirth or early neonatal death 
4. Major congenital anomaly or prolonged NICU stay 
5. Severe maternal complications (hemorrhage, hysterectomy, severe 
preeclampsia/eclampsia, severe infection) 
6. Active psychiatric disorder or psychotropic medication 
7. High-dose opioid need interfering with assessments 
8. Cognitive impairment or inability to complete questionnaires 
9. Withdrawal from study or inability to complete follow-up 
 
5. STUDY DESIGN AND METHODS 
Study Design 

A parallel-group, randomized controlled, multicenter clinical trial. 
Study Groups 
1. ERAS Group (Intervention): 
o Shortened fasting 
o Carbohydrate loading 
o Multimodal opioid-sparing analgesia 
o Early oral intake 
o Early mobilization 
o Early urinary catheter removal 
o Immediate/early skin-to-skin contact 
o Early breastfeeding initiation 
2. Standard Care Group (Control): 
o Routine perioperative management according to institutional protocol 
Study Timeline 
 
Before delivery: Consent, demographics, obstetric history 
 
2 hours postpartum: MIBS, EPDS, early bonding indicators 
 
24 hours postpartum: PBQ, breastfeeding status 
 
Day 4: PBQ (phone or clinic) 
 
Day 7: PBQ (mother and father), EPDS, satisfaction scores 
Randomization 
1:1 allocation using computer-generated random blocks; stratified by 
 
Parity (primiparous vs multiparous) 
 
Planned anesthesia type (spinal vs general) 
Blinding 
 
Outcome assessors: Blinded 
 
Data analysts: Blinded 
 
Participants/care providers: Not blinded (nature of intervention) 

 
6. DATA COLLECTION 
Standardized Case Report Forms (CRFs) will be used. 
All data coded, stored securely for at least 15 years. 
Source data verification and periodic monitoring will ensure accuracy. 
 
 
7. SAFETY AND ETHICAL CONSIDERATIONS 
 
No additional medical risk expected 
 
Conducted under Helsinki Declaration and GCP 
 
Adverse events will be recorded and reported 
 
Participant confidentiality ensured per local regulations 
 
 
8. REFERENCES 
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2. Özdemir MG, Gunaydin B, Bayram M, Hirfanoglu İM. Effect of enhanced recovery after 
surgery (ERAS) protocol on maternal and fetal outcomes following elective cesarean section: 
an observational trial. BMC Pregnancy Childbirth. 2025 Apr 29;25(1):517. doi: 
10.1186/s12884-025-07583-3. PMID: 40301800; PMCID: PMC12039287. 
3. Widström AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first 
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