An interventional study of ERAS protocol in Cesarean Section Complications and ERAS, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
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.
Procedure: ERAS protocol
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.
The combination of interventions explained in arm descriptions.
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
Time frame: Within postoperative 48 hours
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
Time frame: At post operative 6th and 24th hour
Quality of recovery
Evaluated with Quality of recovery-15 (QoR-15) questionnaire
Time frame: Immediately before discharge
Plan to share: No
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital