ERASERACSNCT06225557
Comparison of Outcome Between (ERACS) Versus Traditional Methods in Elective CS
A study testing ERAS community recommendation and Traditional postoperative care in people with ERAS, run by Minia University.
Trial summary
The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ERAS
- What is being tested?
- ERAS community recommendation and Traditional postoperative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.
Who cannot join
- -Age less than 18 years
- Complications (wound infection, re-exploration, caesarean hysterectomies)
- Recent documented use of opioids Allergy to any drug used during the study.-
- Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.
- uncontrolled diabetic patient
- Severe liver and kidney diseases
- Coagulation defect
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Outcome Between the Implementation of Enhanced Recovery After Elective Cesarean Section Protocol (ERACS) Versus Traditional Methods
The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.
Read the detailed description
The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.
Secondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge.
- Conditions
- ERAS
- Being tested
- ERAS community recommendation, Traditional postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS community recommendationOther
Enhanced recovery techniques including opioid sparing anesthesia in elective cesarean section
Traditional postoperative careOther
Usual anesthesia and analgesia in elective cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| ERAS society guidlines | Experimental | The ERAS society guidelines for elective cesarean section will be followed. Receives: Other: ERAS community recommendation |
| Traditional methods | Experimental | Traditional methods in postoperative care for elective cesarean section will be followed. Receives: Other: Traditional postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstetric Quality of Recovery 11 score (ObsQoR-11)
it is consisted of 11 questions covers four domains of recovery outcomes: physical comfort, emotional state, physical independence and care of the neonate, and pain ,each question taking score from 0 to 10 with 0 is the minimum score and 10 is the highest score and the maximum total score is 110 and the minimum total is 0 which is the worest quality of recovery
Measured: before discharge or during 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start10 Mar 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (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 Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- follow ERAS society guidelines recommendations in elective CESAREAN SECTION
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelrehim Attia Mohamed, Minia University
- Investigators
- Ahmad EZ Mahran, professor, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225557
- Sponsor's protocol ID
- 383/08/2022
- Acronym
- ERACS
- Status last verified
- Mar 2024
- First submitted
- 2 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome Between the Implementation of Enhanced Recovery After Elective Cesarean Section Protocol (ERACS) Versus Traditional Methods
- ClinicalTrials.gov ID
- NCT06225557
- Acronym / sponsor ID
- ERACS / 383/08/2022
- Conditions
- ERAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Jan 2024 (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.
The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient's outcome measures.
Detailed description
The study is designed to evaluate the effect of implementing enhanced recovery after surgery (ERAS) protocol during elective cesarean section on patient outcome measures. The primary outcome is the evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery 11 score (ObsQoR-11) at the time of discharge.
Secondary outcomes are the evaluation of peak numeric postoperative pain rating score within the postoperative hospital stay, total amount of postoperative opioid consumption, postoperative nausea, and vomiting impact score after 6 hours postoperatively and at time of discharge, patient satisfaction using Leiden perioperative care patient satisfaction questionnaire (LPPSq) at time of discharge, presence of post-cesarean ileus and Hospital length to achieve criteria for discharge.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- follow ERAS society guidelines recommendations in elective CESAREAN SECTION
| Arm | Type | Receives |
|---|---|---|
| ERAS society guidlines | Experimental | Other: ERAS community recommendationThe ERAS society guidelines for elective cesarean section will be followed. |
| Traditional methods | Experimental | Other: Traditional postoperative careTraditional methods in postoperative care for elective cesarean section will be followed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women ASA I to ASA II aged from 18 up to 40 years. With non-complicated pregnancy undergoing elective CS.
Key exclusion criteria (7 listed)
- -Age less than 18 years
- Complications (wound infection, re-exploration, caesarean hysterectomies)
- Recent documented use of opioids Allergy to any drug used during the study.-
- Patients with severe heart diseases, cardiac arrhythmia and myocardial injury.
- uncontrolled diabetic patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS community recommendationEnhanced recovery techniques including opioid sparing anesthesia in elective cesarean section | Other | ERAS society guidlines |
| Traditional postoperative careUsual anesthesia and analgesia in elective cesarean section. | Other | Traditional methods |
Primary outcome
Obstetric Quality of Recovery 11 score (ObsQoR-11)
Time frame: before discharge or during 24 hour postoperatively
it is consisted of 11 questions covers four domains of recovery outcomes: physical comfort, emotional state, physical independence and care of the neonate, and pain ,each question taking score from 0 to 10 with 0 is the minimum score and 10 is the highest score and the maximum total score is 110 and the minimum total is 0 which is the worest quality of recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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. This study is not recruiting at the moment.
Ahmad EZ Mahran, professor principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
A study testing ERAS community recommendation and Traditional postoperative care in people with ERAS, run by Minia 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 7 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa AA Mohamed, AS Lecturer (00201005431155, marwaelhelaly@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstetric Quality of Recovery 11 score (ObsQoR-11) (time frame: before discharge or during 24 hour postoperatively). 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 5 Mar 2024.