- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242924
Enhanced Recovery After Emergency Cesarean Section: A Comparative Study Assessing Postoperative Recovery and Outcomes (ERAS)
Cesarean section (CS) remains one of the most common major surgical procedures worldwide, with emergency CS accounting for approximately 30% of cases. Emergency CS presents unique challenges including increased maternal stress, higher complication rates, and prolonged recovery compared to elective procedures . Enhanced Recovery After Surgery (ERAS) protocols offer a promising approach to optimize outcomes in this population.
Originally developed for colorectal surgery, ERAS principles have been successfully adapted to obstetric practice over the past decade. These evidence-based protocols emphasize multimodal interventions including preoperative counseling, optimized analgesia, early mobilization, and timely nutrition. In obstetrics, ERAS implementation has demonstrated reduced length of stay, decreased opioid use, and improved patient satisfaction for elective CS .
Application of ERAS to emergency CS requires special considerations due to the urgent nature of the procedure. Modified protocols focus on rapid preoperative assessment, regional anesthesia with intrathecal opioids, and immediate postoperative care initiation . Emerging evidence suggests these adaptations maintain benefits while accommodating time constraints . Key outcomes include reduced postoperative pain, earlier return of bowel function, and improved breastfeeding rates .
Current research demonstrates ERAS protocols can be safely implemented in emergency CS with proper staff training and institutional support . Ongoing studies continue to refine optimal practices, particularly regarding fluid management and thromboprophylaxis . As evidence accumulates, standardized guidelines for emergency CS ERAS pathways are expected to emerge .
Study Overview
Status
Conditions
Detailed Description
The study is conducted on two phases. First phase study tools will be prepared. This is followed by the first and second audit cycles, preparatory phase is done to assess the intra-operative and post-operative care of women undergoing emergency cesarean section using the guidelines of Enhanced recovery after Surgery society. The quality of recovery score-11 translated into arabic. Permission is sought from adminstritive authorities.
First audit cycle : compliance with intraoperative measures is obtained by direct observation . post-operative information will be obtained by patient interview and record audit. The quiality of recovery will be assessed just before discharge using the quality of recovery score (ObsQoR-11).
Corrective action : gaps identified by first audit cycle is translated into defined corrrective measures.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- singleton pregnancy who undergoing emergency cesarean section after 34weeks and accepting to be included in the study.
Exclusion Criteria:
- Pregnant woman who had previous rupture uterus.
- Other medical disorders as hypertensive disorder during pregnancy, cardiac disease.
- Intra-operative complications necessitating changes in post-operative care e.g. bowel injury, urinary tract injury.
- Hemodynamically unstable (post-partum hemorrhage)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Enhanced Recovery After Surgery protocol for emergency cesarean section
Application of ERAS protocol delivered perioperatively and postoperatively as per institutional ERAS guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assess the obstetric ObQOR11scrore at 12 hours and 24 hours post-operative
Time Frame: From enrollment till discharge after 24 hours.
|
A data collection tool will be prepared for the study.
After screening for eligibility, demographic factors, obstetric history.
weight and gain, quality of previous cesarean scar if any, hemoglobin will be assessed for all patients.
Observation of the outcomes will be recorded in the first phase of the study using a structured proforma and the Arabic version of ObQOR-11 score.
Secondary outcomes measures include first oral intake, first abulation, first urination after catheter removal, passage of flatus and pain visual analog scale every 4 hours till discharge.
|
From enrollment till discharge after 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary outcome
Time Frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Time to first oral intake
|
During hospital stay up to discharge, typically within 24-48 hours postoperative
|
|
Secondary outcome
Time Frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Time to passage of flatus
|
During hospital stay up to discharge, typically within 24-48 hours postoperative
|
|
Secondary outcome
Time Frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Time to first ambulation
|
During hospital stay up to discharge, typically within 24-48 hours postoperative
|
|
Secondary outcome
Time Frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Time to first urination after catheter removal
|
During hospital stay up to discharge, typically within 24-48 hours postoperative
|
|
Secondary outcome
Time Frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Pain visual analog scale (VAS) scores every 4 hours until discharge
|
During hospital stay up to discharge, typically within 24-48 hours postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ERAS after emergency cs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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