Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cesarean Section Complications
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Adverse composite outcome
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
gizem boz izceyhan
Gizem Boz İzceyhan, MD
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Eligibility Criteria
Inclusion Criteria
- •Pregnant women who had cesarean delivery
- •Gestational age \>37/0 weeks
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Adverse composite outcome
Time Frame: 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 Outcomes
- Postoperative pain(At post operative 6th and 24th hour)
- Quality of recovery(Immediately before discharge)