Enhanced recovery after cesarean delivery.
Unyime Ituk, Ashraf S Habib
https://pubmed.ncbi.nlm.nih.gov/29770203Actively Recruiting
Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID07276126
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Led by Okan University · Updated on 2026-04-28
1
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the Enhanced Recovery After Cesarean (ERAS) protocol compared with standard perioperative care on mother-infant and father-infant bonding in women undergoing cesarean delivery. This multicenter, randomized controlled trial aims to assess whether the ERAS protocol can improve early emotional bonding, maternal mental health, breastfeeding initiation, and neonatal outcomes. The study is designed to provide high-quality evidence on psychosocial and clinical benefits of ERAS in cesarean deliveries, an area with limited previous research, especially regarding father-infant bonding. Participants will be randomly assigned to either the ERAS protocol group or the standard care group. The ERAS protocol includes preoperative education and anxiety reduction, multimodal opioid-sparing analgesia during surgery, early oral intake, early mobilization, early removal of urinary catheter, and encouragement of skin-to-skin contact and early breastfeeding with active father involvement. The standard care group will receive routine cesarean perioperative care without these enhancements. The study begins as a single-center trial and will expand to multiple centers once prepared. Participants will be assessed multiple times after cesarean delivery: at 2 hours, 24 hours, 4 days, and 7 days postpartum. Researchers will collect data on mother-infant and father-infant bonding using validated questionnaires, maternal depression scores, breastfeeding initiation times, neonatal intensive care needs, and maternal clinical recovery measures. Outcome assessors and data analysts will remain blinded to treatment allocation to reduce bias. The total target sample size is 300 participants across centers, with an initial 100 participants at the first site.
CONDITIONS
Brief Title
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Pregnant women aged 18 to 60 years
- Singleton, live fetus with gestational age of 37 weeks or more
- Undergoing elective or medically indicated cesarean delivery
- Ability to read and understand Turkish
- Mothers and fathers willing and able to complete postpartum follow-up assessments at 2 hours, 24 hours, day 4, and day 7
- Provision of written informed consent by mother and, if participating, by father/partner
- Maternal postpartum clinical stability allowing questionnaire completion
You will not qualify if you...
- Preterm birth before 37 weeks or multiple gestation (twins, triplets)
- Stillbirth, early neonatal death, or major congenital anomaly
- Newborn requiring prolonged NICU stay preventing bonding assessments
- Severe maternal obstetric complications including 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 or understand Turkish or cognitive impairment preventing questionnaire completion
- Failure to complete scheduled follow-up visits
- Withdrawal of consent at any time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Hospital stay until discharge, typically several days postpartum
Participants undergo cesarean delivery and receive either the Enhanced Recovery After Cesarean (ERAS) protocol or standard perioperative care. The ERAS protocol includes preoperative education, multimodal analgesia, early oral intake, early mobilization, early removal of urinary catheter, skin-to-skin contact, early breastfeeding initiation, and involvement of fathers in postpartum care. Standard care follows routine hospital practices without these specific interventions.
1 hospitalization period including delivery and immediate postpartum care
Postpartum Follow-up
Duration - 7 days postpartum
Participants complete follow-up assessments to evaluate mother-infant and father-infant bonding, maternal postpartum depression, breastfeeding success, and neonatal outcomes at multiple time points after delivery.
Assessments at 2 hours, 24 hours, Day 4, and Day 7 postpartum
Trial Site Locations
Total: 1 location
1
Istanbul Okan University Hospital
Istanbul, Turkey (Türkiye), 34947
Actively Recruiting
Loading map...
Research Team
G
Gökçenur Karakelleoğlu, Assist Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Effect of enhanced recovery after surgery (ERAS) protocol on maternal and fetal outcomes following elective cesarean section: an observational trial.
Miray Gözde Özdemir, Berrin Gunaydin, Merih Bayram...
https://pubmed.ncbi.nlm.nih.gov/40301800Skin-to-skin contact the first hour after birth, underlying implications and clinical practice.
Ann-Marie Widström, Kajsa Brimdyr, Kristin Svensson...
https://pubmed.ncbi.nlm.nih.gov/30762247Effect of mother/infant skin-to-skin contact on postpartum depressive symptoms and maternal physiological stress.
Ann Bigelow, Michelle Power, Janis MacLellan-Peters...
https://pubmed.ncbi.nlm.nih.gov/22537390