Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05786352
• Other study ID #: 141
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• ERAS

Intervention

Procedure:
• ERAS protocol
The combination of interventions explained in arm descriptions.

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Women and Children's Diseases Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of recovery	Evaluated with Quality of recovery-15 (QoR-15) questionnaire	Immediately before discharge