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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04816279
Other study ID # CAQOCACS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date October 2022

Study information

Verified date March 2021
Source Assiut University
Contact Youstina Th Adeeb, Resident
Phone 01001736168
Email nanatharwat45@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 2022
Est. primary completion date April 2022
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15. — View Citation

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. — View Citation

Kleiman AM, Chisholm CA, Dixon AJ, Sariosek BM, Thiele RH, Hedrick TL, Carvalho B, Tiouririne M. Evaluation of the impact of enhanced recovery after surgery protocol implementation on maternal outcomes following elective cesarean delivery. Int J Obstet Anesth. 2020 Aug;43:39-46. doi: 10.1016/j.ijoa.2019.08.004. Epub 2019 Aug 21. — View Citation

Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14. — View Citation

Mullman L, Hilden P, Goral J, Gwacham N, Tauro C, Spinola K, Rosales K, Collier S, Holmes L, Maccione J, Pitera R, Miller R, Yodice P. Improved Outcomes With an Enhanced Recovery Approach to Cesarean Delivery. Obstet Gynecol. 2020 Oct;136(4):685-691. doi: 10.1097/AOG.0000000000004023. — View Citation

Tan HS, Habib AS. The optimum management of nausea and vomiting during and after cesarean delivery. Best Pract Res Clin Anaesthesiol. 2020 Dec;34(4):735-747. doi: 10.1016/j.bpa.2020.04.012. Epub 2020 Apr 23. Review. — View Citation

Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the percentage of compliance of care with ERAS society guidelines compliance of routinely provided care with ERAS society guidelines baseline
Secondary Quality of recovery after elective caesarean section better recovery experience with less length of stay at hospital baseline
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