Enhanced Recovery After Cesarean Section

March 23, 2021 updated by: Youstina Tharwat Adeeb, Assiut University

Clinical Audit on the Quality of Care of Elective Caesarean Section

  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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women undergoing scheduled and arranged cesarean sections

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
First Audit cycle
Second Audit cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of compliance of care with ERAS society guidelines
Time Frame: baseline
compliance of routinely provided care with ERAS society guidelines
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery after elective caesarean section
Time Frame: baseline
better recovery experience with less length of stay at hospital
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CAQOCACS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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