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Enhanced Recovery After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816279
Recruitment Status : Not yet recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Youstina Tharwat Adeeb, Assiut University

Study Description
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Brief Summary:
  1. Measure compliance of the care of elective caesarean section with ERAS standards
  2. Measure the quality of recovery of women undergoing elective caesarean section

Condition or disease
Cesarean Section Quality Of Care

Detailed Description:

Caesarean section is one of most common surgeries worldwide and in Egypt. The Egyptian Demographic and Health Survey 2014 revealed a rising caesarean section rate .

Many of these procedures are elective allowing time for preparation of the patient for surgery.

Enhanced recovery after surgery (ERAS) is a multimodal, multi disciplinary, evidence based approach to surgical care with an ultimate goal to enhance recovery and improve maternal and neonatal outcome .

This is done through optimizing multiple aspects of patient care to enhance recovery and so accelerate (facilitate) earlier discharge (decrease length of stay, decrease opioids use and encourage breastfeeding) .

A comparative study in Egypt found ERAS to be effective in controlling perioperative gastrointestinal symptoms, pain control and encourages early ambulation with offering earlier resumption of intestinal motility, higher satisfaction and fewer days of admission .

The clinical audit is a tool for assessing the compliance of current practice with the standard of care. In an audit, both process of care compliance and outcome of care can be measured to highlight gaps that need to be addressed by the institution . Enhanced Recovery After Surgery society issued Guidelines for elective Cesarean Section care .

They include elements in preoperative, intraoperative and postoperative care. Compliance with each of these items was associated with improved maternal or neonatal outcome and a better recovery experience .

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Clinical Audit on the Quality of Care of Elective Caesarean Section
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Group/Cohort
First Audit cycle
Second Audit cycle


Outcome Measures
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Primary Outcome Measures :
  1. the percentage of compliance of care with ERAS society guidelines [ Time Frame: baseline ]
    compliance of routinely provided care with ERAS society guidelines


Secondary Outcome Measures :
  1. Quality of recovery after elective caesarean section [ Time Frame: baseline ]
    better recovery experience with less length of stay at hospital


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
women undergoing scheduled and arranged cesarean sections
Criteria

Inclusion Criteria:

  • Women undergoing elective caesarean section in the study period

Exclusion Criteria:

  • Women who cannot apply ERAS protocol

    1. emergency caesarean section
    2. anticipated surgical difficulty e.g. placenta previa/accrete, tumors obstructing lower uterine segment
    3. Severe maternal disease
    4. severe intraoperative bleeding or visceral injuries necessitating modification of postoperative care
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816279


Contacts
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Contact: Youstina Th Adeeb, Resident 01001736168 nanatharwat45@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Publications:
From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO), Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rüfenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22.

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Responsible Party: Youstina Tharwat Adeeb, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT04816279    
Other Study ID Numbers: CAQOCACS
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No