ERASERASNCT07242924
Enhanced Recovery After Emergency Cesarean Section: A Comparative Study Assessing Postoperative Recovery and Outcomes
An observational study of ERAS and Cesarean Section Pain, run by Assiut University.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- ERAS, Cesarean Section Pain
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Pregnant patients admitted to Woman's Health hospital, Assiut university labor ward and post-partum.
Who may be able to join
- singleton pregnancy who undergoing emergency cesarean section after 34weeks and accepting to be included in the study.
Who cannot join
- 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)
About this study
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 .
Read more
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 .
Read the 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.
- Conditions
- ERAS, Cesarean Section Pain
- Keywords
- ERAS, ERAS, emergency cs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery protocol for emergency cesarean section | Application of ERAS protocol delivered perioperatively and postoperatively as per institutional ERAS guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the obstetric ObQOR11scrore at 12 hours and 24 hours post-operative
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.
Measured: From enrollment till discharge after 24 hours.
Secondary outcomes (5)
Secondary outcome
Time to first oral intake
Measured: During hospital stay up to discharge, typically within 24-48 hours postoperative
Secondary outcome
Time to passage of flatus
Measured: During hospital stay up to discharge, typically within 24-48 hours postoperative
Secondary outcome
Time to first ambulation
Measured: During hospital stay up to discharge, typically within 24-48 hours postoperative
Secondary outcome
Time to first urination after catheter removal
Measured: During hospital stay up to discharge, typically within 24-48 hours postoperative
Secondary outcome
Pain visual analog scale (VAS) scores every 4 hours until discharge
Measured: During hospital stay up to discharge, typically within 24-48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Abbady Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242924
- Sponsor's protocol ID
- ERAS after emergency cs
- Acronym
- ERAS
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Emergency Cesarean Section: A Comparative Study Assessing Postoperative Recovery and Outcomes
- ClinicalTrials.gov ID
- NCT07242924
- Acronym / sponsor ID
- ERAS / ERAS after emergency cs
- Conditions
- ERAS, Cesarean Section Pain
- Keywords
- ERAS, ERAS, emergency cs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery protocol for emergency cesarean section | – | –Application of ERAS protocol delivered perioperatively and postoperatively as per institutional ERAS guidelines. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant patients admitted to Woman's Health hospital, Assiut university labor ward and post-partum.
Key inclusion criteria (1 listed)
- singleton pregnancy who undergoing emergency cesarean section after 34weeks and accepting to be included in the study.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Secondary outcome
Time frame: 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
Secondary outcome
Time frame: 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
Secondary outcome
Time frame: During hospital stay up to discharge, typically within 24-48 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ERAS and Cesarean Section Pain, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the obstetric ObQOR11scrore at 12 hours and 24 hours post-operative (time frame: From enrollment till discharge after 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.