Evaluation of postpartum depression in patients undergoing cesarean section managed with an ERAS protocol

ISRCTN	ISRCTN16339153
DOI	https://doi.org/10.1186/ISRCTN16339153
Sponsor	Düzce Atatürk State Hospital
Funder	Investigator initiated and funded

Submission date: 23/12/2025
Registration date: 29/12/2025
Last edited: 29/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at registration.

Contact information

Dr Tansu Bahar Gürbüz
Principal investigator, Public, Scientific

Dumlupınar mahallesi Günaydın sokak Adapark 2 a sitesi apartman no:11 kat :3 daire :11
Nilüfer
16240
Türkiye

Phone	+90 05325479464
Email	tansu.gurbuz@iuc.edu.tr

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Health services research, Supportive care
Scientific title	Effect of ERAS protocol after cesarean section on postpartum depression: a randomized controlled trial
Study objectives	The Enhanced Recovery After Surgery (ERAS) protocol is an evidence-based, multidisciplinary approach that includes preoperative, perioperative, and postoperative interventions. These interventions aim to accelerate functional recovery and improve postoperative outcomes. The ERAS protocol seeks to minimize surgery-related complications and optimize the duration of recovery. By reducing preoperative fasting time, ensuring effective pain control, promoting early mobilization, and enabling early postoperative nutrition, ERAS attenuates surgery-induced catabolic and inflammatory responses. The ERAS protocol has been widely implemented across various surgical disciplines, including gynecologic oncology, benign gynecology, urology, and hepatobiliary surgery. Postpartum depression is reported to occur less frequently in populations undergoing normal vaginal delivery. In this study, we aimed to evaluate changes in postpartum depression questionnaire scores in patients who received the ERAS protocol after cesarean section compared with those who did not.
Ethics approval(s)	Approved 10/03/2025, Düzce University Non-Interventional Health Research Ethics Committee (Konuralp, Düzce, 81620, Türkiye; +90 0850 800 81 81; duzceetik@duzce.edu.tr), ref: 2025/26
Health condition(s) or problem(s) studied	Evaluation of postpartum depression following ERAS implementation in patients undergoing cesarean section.
Intervention	Methods Study Design This study was designed as a prospective randomized controlled trial conducted in the Department of Obstetrics and Gynecology. The anticipated study duration is nine months. Participants Patients admitted to the Obstetrics and Gynecology clinic with an indication for cesarean section due to fetal or maternal reasons were eligible for inclusion. Only patients with a clear clinical indication for cesarean delivery were enrolled. No additional interventions beyond standard clinical care were performed. Randomization Eligible participants were randomly assigned to either the ERAS group or the control group using a computer-generated randomization program. Interventions Patients in the intervention group received postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol, while patients in the control group received standard postoperative care. No additional medications were initiated for study purposes. Preoperative, perioperative, and postoperative clinical data and pharmacological treatments were recorded for both groups. Outcomes Primary Outcomes The primary outcomes were early postoperative recovery parameters, including: Time to first postoperative flatus following cesarean delivery Postoperative pain scores Postoperative complications (wound complications, urinary retention, and postpartum hospital readmission) Patient satisfaction Secondary Outcomes The secondary outcome was the assessment of postpartum anxiety and depression after discharge using the Edinburgh Postnatal Depression Scale (EPDS). Outcome Measurements Postpartum pain severity was assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (severe pain). Patients were asked to rate their pain intensity, and scores were recorded. Patient satisfaction was evaluated using a Likert scale (1 = poor, 5 = excellent). VAS and satisfaction scores were collected by physicians during face-to-face ward visits. Data Collection and Management Patient identification data were not included in the study records. All collected data were stored in a computerized archive. After completion of data collection, outcomes were compared between the ERAS and control groups. Ethical Considerations No life-threatening risks were anticipated in this study. No procedures without clinical indication were performed, and no risk factors expected to harm participants were present. No additional medications were administered as part of the study. Statistical Analysis All study data will be analyzed using appropriate statistical methods.
Intervention type	Other
Primary outcome measure(s)	Time to first postoperative flatus following cesarean delivery measured using postpartum pain scores and patient satisfaction scores at the time of cesarean delivery Postpartum anxiety and depression after discharge measured using the Edinburgh Postnatal Depression Scale (EPDS) at the time of discharge
Key secondary outcome measure(s)
Completion date	18/12/2025

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Female
Target sample size at registration	150
Total final enrolment	150
Key inclusion criteria	1. Patients with indications for cesarean section 2. 18-40 age pregnant woman 3. Without a prior diagnosis of psychiatric illness and without current or previous use of psychiatric medications
Key exclusion criteria	1. Presence of preeclampsia or eclampsia 2. Pre-existing hypertension 3. Placental invasion anomalies 4. Placental abruption 5. Pregestational or gestational diabetes mellitus 6. Perioperative complications (including intraoperative bladder or bowel injury) 7. Orthopedic conditions that could limit postoperative mobilization
Date of first enrolment	01/04/2025
Date of final enrolment	08/12/2025

Locations

Countries of recruitment

Türkiye

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

29/12/2025: Study’s existence confirmed by the Düzce University Non-Interventional Health Research Ethics Committee.