The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Mother-Infant Bonding Score at Postpartum Day 7 (PBQ Total Score)
Study Overview
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.
Detailed Description
RATIONALE AND OBJECTIVES Introduction and Study Rationale
Cesarean delivery rates are increasing worldwide and in Turkey, highlighting the importance of not only physical recovery but also psychological and emotional recovery after birth. The Enhanced Recovery After Surgery (ERAS) protocol, initially developed for colorectal surgery, has recently been adapted to obstetrics as "ERAS for Cesarean." ERAS protocols offer concrete clinical benefits in the perioperative period, including enhanced patient comfort, reduced opioid use, earlier mobilization, and shortened hospital stay .
However, evidence regarding the effects of ERAS protocols on mother-infant bonding, breastfeeding success, and postpartum mental health in cesarean deliveries remains limited. Early contact between mother and infant during the first postpartum days increases oxytocin release, supporting not only uterine involution but also emotional bonding. Early skin-to-skin contact and early breastfeeding initiation reduce the risk of postpartum depression, while excessive opioid use and prolonged postoperative immobilization may negatively impact this process.
Key components of ERAS-including preoperative patient education and anxiety reduction, intraoperative multimodal analgesia, early oral intake, early mobilization, and early removal of Foley catheters-not only accelerate maternal physical recovery but may also enhance psychosocial recovery and parent-infant bonding. Recent pilot studies have reported that ERAS improves maternal satisfaction with birth experience, perceived self-efficacy, and reduces depressive symptoms. However, most of these studies were single-center, small sample size, and assessed psychosocial outcomes as secondary endpoints.
In Turkey, no randomized controlled trial has evaluated the relationship between ERAS protocols and parent-infant bonding after cesarean delivery. Moreover, father-infant bonding is an understudied area in obstetric literature. Cesarean delivery may limit fathers' initial contact with the newborn, potentially delaying emotional bonding. The ERAS protocol, by facilitating early skin-to-skin contact and integrating fathers into postpartum care, may mitigate these limitations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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.
Arms & Interventions
ERAS Protocol
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.
Intervention: ERAS Protocol (Behavioral)
Standard Perioperative Care
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.
Intervention: Standard Perioperative Care (Behavioral)
Outcomes
Primary Outcomes
Mother-Infant Bonding Score at Postpartum Day 7 (PBQ Total Score)
Time Frame: Postpartum Day 7
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.
Secondary Outcomes
- Mother-Infant Bonding Score at 2 Hours Postpartum (MIBS Score)(2 hours postpartum)
Investigators
Gökçenur Karakelleoğlu
Assisted Prof
Okan University