Clinical trial NCT05786352: Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol
Official title: Outcomes of Enhanced Recovery After Surgery (ERAS) vs. Standard of Care in Cesarean Deliveries: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
ERAS
Keywords: ERAS
ERAC
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Adverse composite outcome
timeFrame: Within postoperative 48 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: At post operative 6th and 24th hour
measure: Quality of recovery
timeFrame: Immediately before discharge
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Women and Children's Diseases Training and Research Hospital
Study officials:
References: