ERAS versus standard perioperative care for parent-infant bonding after cesarean delivery
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
This trial will test whether using the ERAS protocol after cesarean helps mothers and fathers bond with their newborns compared with standard perioperative care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Okan University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07276126 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-group trial compares an Enhanced Recovery After Surgery (ERAS) protocol to standard perioperative care for women undergoing cesarean delivery, starting at Istanbul Okan University Hospital and expanding to additional centers after site preparation. Participants are randomized 1:1 to ERAS—which includes preoperative education, multimodal analgesia, early oral intake, early mobilization, and early catheter removal—or to usual care, and fathers are invited to participate in bonding assessments. The primary outcome is mother-infant bonding measured by the Postpartum Bonding Questionnaire (PBQ) on postpartum day 7, with secondary outcomes including early attachment scales and Edinburgh Postnatal Depression Scale scores at 2 hours, 24 hours, day 4, and day 7. The design aims to capture early psychosocial effects of perioperative pathways on both maternal and paternal bonding.
Who should consider this trial
Good fit: Ideal candidates are Turkish-speaking pregnant women aged 18–60 with a singleton, term (≥37 weeks) pregnancy undergoing elective or indicated cesarean delivery whose partners are willing to complete postpartum questionnaires.
Not a fit: Patients with preterm birth, major neonatal complications requiring prolonged NICU care, severe maternal obstetric complications (e.g., massive hemorrhage, hysterectomy, severe preeclampsia/eclampsia), active severe psychiatric disorder, or inability to complete Turkish questionnaires are unlikely to benefit from the study intervention.
Why it matters
Potential benefit: If successful, ERAS could improve early mother-infant and father-infant bonding while supporting faster physical recovery and potentially lowering postpartum mood problems.
How similar studies have performed: ERAS has documented benefits for physical recovery and reduced opioid use in obstetrics in pilot and observational reports, but randomized evidence showing improved parent-infant bonding is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul
- Istanbul Okan University Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Gökçenur Karakelleoğlu, Assist Prof
- Email: gokcenur.karakelleoglu@okan.edu.tr
- Phone: +905326702049
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.