Enhanced Recovery After Cesarean Section | NCT04816279

Studies
Enhanced Recovery After Cesarean Section

NCT04816279

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 25, 2021Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Cesarean Section
Quality Of Care

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Apr 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2021

Last Update Posted Date

Mar 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

women undergoing scheduled and arranged cesarean sections

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Youstina Th Adeeb, Resident	Contact	01001736168		nanatharwat45@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31522935	Background	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.
32925620

Label	Type	Description	Intervention Names
First Audit cycle
Second Audit cycle