Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

Not Applicable

• Conditions: ERAS; Cesarean Section Complications
• Interventions: Procedure: ERAS protocol

• Registration Number: NCT05786352
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-04
• Study First Submitted QC: 2023-03-23
• Last Update Submitted: 2023-03-23
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27
• Study Start: 2023-04-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS	ERAS protocol	ERAS Protocol Preoperative: 1. Clear carbohydrate ( pulp free juice) drink 4 hours before cesarean. Water drinking is allowed until 4 hours before cesarean. 2. Prophylactic antibiotics 1 hour before cesarean ( Cephazole 2 g iv) Intraoperative: 1. Hypothermia prevention (warming devices) 2. Pneuomatic compression stockings 3. Skin preparation with clorhexidine-alcohol 4. Vaginal preparation with povidone-iodine solution Postoperative: 1. Regular diet within 2 hours after cesarean 2. Sugar-free gum chewing at postoperative 3rd, 5th and 7th hours, for 20 minutes 3. Tight control of capillary blood glucose 4. Mobilization at postoperative 4th hour. 5. Urinary catheter removal at postoperative 4th hour 6. Pneuomatic compression stockings 7. Prevention of nausea and vomiting with routine use of Metoclopramide. 8. Routine analgesia with Diclofenac sodium suppository application and oral Paracetamole.

Primary Outcome Measures

Name	Time	Method
Adverse composite outcome	Within postoperative 48 hours	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	At post operative 6th and 24th hour	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
Quality of recovery	Immediately before discharge	Evaluated with Quality of recovery-15 (QoR-15) questionnaire

Trial Locations

Locations (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital; 🇹🇷 Istanbul, Turkey