Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial

In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial cost in the context of cesarean sections has been shown in several studies. There is strong evidence that following ERAS protocols aids postoperative recovery positively. This will be a randomized trial to determine if there is a difference regarding adverse maternal outcomes between ERAS group and standard of care.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cesarean Section Complications; ERAS
• Intervention / Treatment: Procedure: ERAS protocol

Detailed Description

Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Our institiution is a tertiary maternity hospital with approximately 3500 cesarean sections annually. A standardized set of guidelines known as Enhanced Recovery After Surgery (ERAS) has been used in a variety of surgical specialties, including colorectal, urologic, gynecologic, and hepatobiliary surgery. The adoption of ERAS guidelines for the obstetric population now offers evidence-based recommendations for postoperative care following cesarean delivery.

At our institution, due to large volume of cesarean section, we encounter a variety of postoperative complications. Institutional standard of care for preoperative, intraoperative and postoperative care has been applied by all providers. In light of recent positive evidence when ERAS protocol is applied, our team aimed to design a randomized controlled trial for comparison of maternal outcomes in ERAS and standard of care.

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women who had cesarean delivery
• Gestational age >37/0 weeks

Exclusion Criteria:

• Diabetes
• Placenta accreta spectrum
• Hypertensive disorders of pregnancy
• Placental abruption
• Need for emergent/urgent cesarean
• Pregnancy complicated by an active infection
• History of allergic reaction to diclofenac sodium, paracetamol or metoclopramide

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERAS; ERAS Protocol Preoperative: Clear carbohydrate ( pulp free juice) drink 4 hours before cesarean. Water drinking is allowed until 4 hours before cesarean.; Prophylactic antibiotics 1 hour before cesarean ( Cephazole 2 g iv) Intraoperative: Hypothermia prevention (warming devices); Pneuomatic compression stockings; Skin preparation with clorhexidine-alcohol; Vaginal preparation with povidone-iodine solution Postoperative: Regular diet within 2 hours after cesarean; Sugar-free gum chewing at postoperative 3rd, 5th and 7th hours, for 20 minutes; Tight control of capillary blood glucose; Mobilization at postoperative 4th hour.; Urinary catheter removal at postoperative 4th hour; Pneuomatic compression stockings; Prevention of nausea and vomiting with routine use of Metoclopramide.; Routine analgesia with Diclofenac sodium suppository application and oral Paracetamole.	Procedure: ERAS protocol; The combination of interventions explained in arm descriptions.
No Intervention: SOC (Standard of Care); Preoperative: Fasting until 6 hours before cesarean.; Prophylactic antibiotics post-delivery during cesarean per institutional protocol ( Cephazole 2 g iv) Intraoperative: Pneuomatic compression stockings as needed; Skin preparation with povidone-iodine solution Postoperative: Water intake at 4th hour after cesarean, traditional delayed feeding until return of intestinal function (bowel sounds or flatus); Capillary glucose control; Mobilization at postoperative 6th hour.; Urinary catheter removal at postoperative 6th hour; Pneuomatic compression stockings as needed.; Analgesia with Diclofenac sodium intramuscular and oral Paracetamole as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse composite outcome	One or more of the following: Prolonged length of hospital stay, infectious complication (urinary tract, wound complications etc.), gastrointestinal complications (need for additional treatment for nausea-vomiting, delayed return of intestinal function, ileus etc.), thrombotic complications, readmission	Within postoperative 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Evaluated with visual analog scale (VAS) A pain scoring scale between 0-10 points, where 0 indicates no pain and 10 indicates the worst pain	At post operative 6th and 24th hour
Quality of recovery	Evaluated with Quality of recovery-15 (QoR-15) questionnaire	Immediately before discharge

Collaborators and Investigators

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 4, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ERAS; ERAC
• Other Study ID Numbers: 141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No