How Well do the Current Cesarean Deliveries Adhere to the... | NCT05396417

Studies
How Well do the Current Cesarean Deliveries Adhere to the Published ERAS Guidelines?

NCT05396417

Sponsor

Women's Hospital HUS

Status

Unknown status

Last Update Posted

Apr 26, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cesarean Section Complications

Interventions

cesarean delivery

Countries

Finland

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jul 31, 2023Estimated

Completion Date

Jul 31, 2023Estimated

First Submitted Date

May 27, 2022

First Submission Date that Met QC Criteria

May 27, 2022

First Posted Date

May 31, 2022Actual

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

Apr 24, 2023

Last Update Posted Date

Apr 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.

Detailed Description

The study will produce a snapshot of the current state of treatment in the third largest delivery hospital in Europe. The study will include cesarean deliveries in all urgency categories.

The data will be collected prospectively by enrolling parturients in consecutive order from the study start date. The data will be collected in the form of a paper check list that is to be filled up by the nursing staff and doctors who are taking care of the parturient through her stay at the hospital.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cesarean delivery		Any urgency any reason	Procedure: cesarean delivery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cesarean delivery	Procedure	Cesarean delivery under any form of anesthesia for any reason and for any indication	Cesarean delivery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery	To which extent does the postoperative treatment of the parturients meet the ERAS criteria	3 days post surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible for ERAS protocol cesarean delivery
Cesarean delivery for any indication
Any anesthesia method
Any urgency category

Exclusion Criteria:

Age under 18 years

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Women undergoing cesarean delivery at the University of Helsinki central hospital/Women's hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HUS/Women's hospital dept of obstetrics		Helsinki		00029	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002585	Cesarean Section

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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