Enhanced Recovery Protocol After Cesarean Section

NCT07720986 | Completed DMC

• 1 other identifier: ERAC
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of implementing the Enhanced Recovery After Cesarean (ERAC) protocol on maternal and neonatal outcomes. Research hypotheses To fulfill the aim of the study, the following research hypotheses are formulated: Hypothesis I: Women who receive the ERAC protocol experience faster recovery compared to those who receive routine hospital nursing care. Hypothesis II: Women who receive the ERAC protocol experience fewer maternal and neonatal complications than those who receive routine hospital nursing care.

Conditions

Cesarean Section

Keywords

Cesarean Section; Maternal outcome; Neonatal Outcome; ERAS; ERAC

Outcome Measures

Primary Outcomes (1)

• Maternal quality of recovery score

  Maternal quality of recovery will be measured using a 40-item questionnaire. Each item is rated on a three-point Likert scale: 1 = rarely, 2 = sometimes, and 3 = always. Scores are reversed for negatively worded items. Total scores range from 40 to 120, with higher scores indicating better quality of recovery and lower scores indicating poorer quality of recovery.

  at day 0 and 2 weeks postoperative

Secondary Outcomes (9)

• Incidence of intraoperative hypotension

  day 0 of surgery

• Incidence of intraoperative nausea and vomiting

  During cesarean delivery.

• Time to first semisolid food intake

  From completion of surgery until first semisolid food intake during hospitalization.

• Time to first ambulation

  From completion of surgery until first ambulation during hospitalization.

• Hospital length of stay

  From completion of surgery until hospital discharge.

Study Arms (2)

Experimental :ERAC arm (intervention)

EXPERIMENTAL

The intervention group will receive the Enhanced Recovery After Cesarean (ERAC) protocol of care, consisting of the following components: Preoperative care: * Patient education. * Reduced preoperative fasting: solid food will be permitted until 6 hours before surgery, and clear fluids until 2 hours before surgery. * Preoperative carbohydrate loading. Intraoperative care: * Antibiotic prophylaxis. * Thermal regulation using active warming methods, warmed intravenous fluids, and maintenance of an appropriate operating room temperature. * Neuraxial anesthesia with strategies to prevent maternal hypotension. * Delayed cord clamping for 30-60 seconds after birth. * Immediate maternal-newborn bonding through skin-to-skin contact and early initiation of breastfeeding in the operating room, when clinically feasible. Postoperative care: • Prophylaxis for pos

Procedure: Enhanced Recovery after Cesarean protocol of Care

Routine care arm

ACTIVE COMPARATOR

The control group will receive routine nursing care only (pre-operative, intraoperative and postoperative).NPO for at least 8 hrs for food and fluid ,immediate cord clamping ,no mutlimodal analgesia ,catheter removal after at least 12 hrs

Procedure: Routine hospital care

Interventions

Routine hospital care PROCEDURE

The control group will receive routine preoperative, intraoperative, and postoperative nursing care according to standard hospital practice. Preoperative care: • Fasting from both food and fluids for at least 8 hours before surgery. Intraoperative care: • Immediate umbilical cord clamping after birth. Postoperative care: * Analgesia according to routine hospital practice without a standardized multimodal analgesic regimen. * Urinary catheter removal at least 12 hours after surgery.

Routine care arm

Enhanced Recovery after Cesarean protocol of Care PROCEDURE

• The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperature \>72.8°F (22.7°C). * Anesthesia: Neuraxial anesthesia with hypotension prevention strategies (fluid preloading/co-loading and phenylephrine infusion). * Delayed cord clamping: For 30-60 seconds after birth. * Immediate maternal-newborn

Experimental :ERAC arm (intervention)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Pregnant women undergoing CS
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing planned cesarean delivery.
• Scheduled to receive neuraxial anesthesia.
• Gestational age of 37 weeks or more.
• Singleton pregnancy.

You may not qualify if:

• Women requiring additional interventions outside the Enhanced Recovery After Cesarean (ERAC) pathway, including severe coagulopathy or active infection.
• Women expected to require prolonged hospitalization because of a history of uterine rupture, pre-existing hypertension, pregnancy-induced hypertension, or placenta accreta.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakhalia, 34511, Egypt

Location

Study Officials

• Noura G El-Gamel, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Enas S Fathy

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study will be conducted as a single-blind randomized controlled trial, where participants will be blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Participants in the control group will receive the standard perioperative nursing care routinely provided at the study site, including conventional preoperative, intraoperative, and postoperative practices without a structured protocol. • The intervention group will receive the Enhanced Recovery after Cesarean protocol of Care which consists of: Preoperative Care: * Patient education covering the procedure, perioperative expectations, pain management plan, early oral intake and mobilization goals, discharge criteria, and follow-up schedule. * Minimizing fasting: Solid food allowed up to 6 hours and clear fluids up to 2 hours prior to surgery. * Carbohydrate loading: Administration of 45g non-particulate carbohydrate drink up to 2 hours before surgery for non-diabetic mothers. Intraoperative Care: * Antibiotic prophylaxis: Administered within 60 minutes prior to skin incision. * Thermal regulation: Use of active warming methods, warmed IV fluids, and maintaining operating room temperatu

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)