Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

NCT ID: NCT05786352

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-06-01

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.

Conditions

Cesarean Section Complications; ERAS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ERAS

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.

Group Type: EXPERIMENTAL

ERAS protocol

Intervention Type: PROCEDURE

The combination of interventions explained in arm descriptions.

SOC (Standard of Care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ERAS protocol

The combination of interventions explained in arm descriptions.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

gizem boz izceyhan

Gizem Boz İzceyhan, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

141

Identifier Type: -

Identifier Source: org_study_id