Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section Complications, ERAS

Intervention / Treatment
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* Procedure: ERAS protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS<br>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<br>* The combination of interventions explained in arm descriptions.<br>|
| No Intervention: SOC (Standard of Care)<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, ERAC