Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Status: Invitation-only

Conditions: ERAS; Cesarean Section Complications

Treatments: Procedure: ERAS protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05786352

141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

ERAS

Experimental group

Description:

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.

Treatment:

Procedure: ERAS protocol

SOC (Standard of Care)

No Intervention group

Description:

Preoperative: 1. Fasting until 6 hours before cesarean. 2. Prophylactic antibiotics post-delivery during cesarean per institutional protocol ( Cephazole 2 g iv) Intraoperative: 1. Pneuomatic compression stockings as needed 2. Skin preparation with povidone-iodine solution Postoperative: 1. Water intake at 4th hour after cesarean, traditional delayed feeding until return of intestinal function (bowel sounds or flatus) 2. Capillary glucose control 3. Mobilization at postoperative 6th hour. 4. Urinary catheter removal at postoperative 6th hour 5. Pneuomatic compression stockings as needed. 6. Analgesia with Diclofenac sodium intramuscular and oral Paracetamole as needed.