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

RecruitingNAAges 18 Years - 60 YearsAllOkan University
NCT07276126 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 scor

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📋 Eligibility rules (as published)
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.
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What it tests

  • ERAS Protocol
  • Standard Perioperative Care
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Where

1 site
Istanbul Okan University Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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