The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.

NCT07276126 | Recruiting

• 1 other identifier: E-66291034-202.3.02-7579
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Maternal Care; Father - Child Relations; Mother-Infant Interaction; Bonding; ERAS

Keywords

eras; erac; cesarean; maternal bonding; paternal bonding

Outcome Measures

Primary Outcomes (1)

• Mother-Infant Bonding Score at Postpartum Day 7 (PBQ Total Score)

  The primary outcome is the maternal bonding score assessed on postpartum day 7 using the validated Postpartum Bonding Questionnaire (PBQ). The PBQ total score evaluates the quality of early emotional bonding between mother and infant across domains including affection, rejection, and anxiety. Higher scores indicate better bonding. The ERAS protocol is hypothesized to improve bonding through enhanced maternal recovery, reduced postoperative discomfort, earlier mobilization, improved emotional well-being, and structured support for early skin-to-skin contact and breastfeeding. PBQ is administered by trained staff blinded to group allocation.

  Postpartum Day 7

Secondary Outcomes (1)

• Mother-Infant Bonding Score at 2 Hours Postpartum (MIBS Score)

  2 hours postpartum

Study Arms (2)

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.

Behavioral: ERAS Protocol

Standard Perioperative Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Perioperative Care

Interventions

Standard Perioperative Care BEHAVIORAL

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.

Standard Perioperative Care

ERAS Protocol 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.

ERAS Protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University Hospital

Istanbul, 34947, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.

  PMID: 29770203 RESULT

• Ozdemir MG, Gunaydin B, Bayram M, Hirfanoglu IM. 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 RESULT

• Widstrom AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first hour after birth, underlying implications and clinical practice. Acta Paediatr. 2019 Jul;108(7):1192-1204. doi: 10.1111/apa.14754. Epub 2019 Mar 13.

  PMID: 30762247 RESULT

• Bigelow A, Power M, MacLellan-Peters J, Alex M, McDonald C. Effect of mother/infant skin-to-skin contact on postpartum depressive symptoms and maternal physiological stress. J Obstet Gynecol Neonatal Nurs. 2012 May-Jun;41(3):369-82. doi: 10.1111/j.1552-6909.2012.01350.x. Epub 2012 Apr 26.

  PMID: 22537390 RESULT

Related Links

• Related Info
• Related Info

Central Study Contacts

Gökçenur Karakelleoğlu, Assist Prof

CONTACT

+905326702049; gokcenur.karakelleoglu@okan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted Prof

Model Details: Arm 1: ERAS Protocol Arm 2: Standard Perioperative Care

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: December 13, 2025
• Primary Completion: February 20, 2026
• Study Completion: April 20, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-11

Locations

TU (1)