ERAS versus standard perioperative care for parent-infant bonding after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istanbul Okan University Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Gökçenur Karakelleoğlu, Assist Prof
• Email: gokcenur.karakelleoglu@okan.edu.tr
• Phone: +905326702049

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Reflexology and hand massage after cesarean section

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• Enhanced Recovery Adherence and Recovery Quality After Cesarean Delivery

  This study tests whether following enhanced recovery after cesarean delivery protocols is linked with better recovery quality in women having a planned cesarean with spinal anesthesia.

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• Predictors of severe pain within 24 hours after cesarean delivery with spinal anesthesia

  This study will look at which pre-, intra-, and post-operative factors are linked to severe pain in the first 24 hours after an elective cesarean done with spinal anesthesia.

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• Enhanced Recovery After Surgery for Gynecologic Procedures

  This study tests whether an ERAS program can help women undergoing gynecologic surgery recover faster compared with traditional perioperative care.

  Recruiting National Taiwan University Hospital · Hsinchu · NCT07764276

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.