NCT04816279

Brief Summary

  1. 1.Measure compliance of the care of elective caesarean section with ERAS standards
  2. 2.Measure the quality of recovery of women undergoing elective caesarean section

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 23, 2021

Last Update Submit

March 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • the percentage of compliance of care with ERAS society guidelines

    compliance of routinely provided care with ERAS society guidelines

    baseline

Secondary Outcomes (1)

  • Quality of recovery after elective caesarean section

    baseline

Study Arms (2)

First Audit cycle

Second Audit cycle

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women undergoing scheduled and arranged cesarean sections

You may qualify if:

  • Women undergoing elective caesarean section in the study period

You may not qualify if:

  • Women who cannot apply ERAS protocol
  • emergency caesarean section
  • anticipated surgical difficulty e.g. placenta previa/accrete, tumors obstructing lower uterine segment
  • Severe maternal disease
  • severe intraoperative bleeding or visceral injuries necessitating modification of postoperative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 31522935BACKGROUND
  • 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.

    PMID: 32925620BACKGROUND
  • 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.

    PMID: 33288123BACKGROUND
  • 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.

    PMID: 30240657BACKGROUND
  • 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.

    PMID: 30118692BACKGROUND
  • 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.

    PMID: 30995461BACKGROUND
  • 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, Rufenacht 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. No abstract available.

    PMID: 29786478BACKGROUND

Central Study Contacts

Youstina Th Adeeb, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2022

Study Completion

October 1, 2022

Last Updated

March 25, 2021

Record last verified: 2021-03