Audit of the Response Time of the Anaesthetic and Surgica... | NCT02314078

Studies
Audit of the Response Time of the Anaesthetic and Surgical Techniques for Crash Caesarean Section

NCT02314078

Sponsor

KK Women's and Children's Hospital

Status

Completed

Last Update Posted

Dec 10, 2014Estimated

Enrollment

390Actual

Phase

Not provided

Conditions

Pregnancy
Anaesthesia

Interventions

Not provided

Countries

Singapore

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Dec 8, 2014

First Posted Date

Dec 10, 2014Estimated

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

Dec 8, 2014

Last Update Posted Date

Dec 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is the standard of practice recommended by clinical guidelines.

Detailed Description

Our institution established a protocol for category-1 ('crash') CS to expedite deliveries. This retrospective audit evaluated all women who underwent category-1 CS in KK Women's and Children's Hospital from 2010 to 2013.

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

390Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decision to delivery interval	Decision for Caesarean section to delivery of foetus	1 hour

Secondary Outcomes

Measure	Description	Time Frame
General anaesthesia	Rate of general anaesthesia	1 hour
Neonatal outcome	APGAR score and cord pH	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Category One Caesarean Section at KK Women's and Children's Hospital, Singapore between 2010 to 2013.

Exclusion Criteria:

No specific exclusion criteria, retrospective audit

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Women who underwent category one Caesarean section between 2010 to 2013 at KK Women's and Children's Hospital, Singapore.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ban L Sng, FANZCA	KK Women's and Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KK Women's and Children's Hospital		Singapore		229899	Singapore

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided