--- title: Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol nct_id: NCT05786352 overall_status: UNKNOWN phase: NA sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital study_type: INTERVENTIONAL primary_condition: Cesarean Section Complications countries: Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05786352.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05786352" ct_last_update_post_date: 2023-03-27 last_seen_at: "2026-05-12T06:42:52.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT05786352](https://clinicaltrials.gov/study/NCT05786352) ## Key Facts - **Status:** UNKNOWN - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1200 - **Lead Sponsor:** Zeynep Kamil Maternity and Pediatric Research and Training Hospital - **Conditions:** Cesarean Section Complications, ERAS - **Start Date:** 2023-04-01 - **Completion Date:** 2024-06-01 - **CT.gov Last Update:** 2023-03-27 ## 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 - **Minimum age:** 18 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **ERAS** (EXPERIMENTAL) — 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. - **SOC (Standard of Care)** (NO_INTERVENTION) — 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. ## Interventions - **ERAS protocol** (PROCEDURE) — The combination of interventions explained in arm descriptions. ## 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** _(time frame: At post operative 6th and 24th hour)_ - **Quality of recovery** _(time frame: Immediately before discharge)_ ## Locations (1) - Zeynep Kamil Women and Children's Diseases Training and Research Hospital, Istanbul, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.zeynep kamil women and children's diseases training and research hospital|istanbul||turkey (türkiye)` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05786352.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05786352* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*