Emergency Home Delivery. Learning Skills for Medical Doct... | NCT06292676

Studies
Emergency Home Delivery. Learning Skills for Medical Doctors and Nurses. Kirkpatrick Levels of Learning

NCT06292676

Sponsor

G. d'Annunzio University

Status

Unknown status

Last Update Posted

Mar 5, 2024Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Home Birth Delivery

Interventions

skills retained for home birth delivery in emergency

Countries

Italy

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

May 20, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Feb 26, 2024

First Submission Date that Met QC Criteria

Mar 4, 2024

First Posted Date

Mar 5, 2024Actual

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 4, 2024

Last Update Posted Date

Mar 5, 2024Actual

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

Mannequin training for emergency home delivery on medical doctors and nurses

Detailed Description

two groups will be exposed to frontal lecture and simulato scenario on emergency home birth. After the first training a debriefing will be done. Following a second scenario will bi performed. All participants will complete a google form questionnaire before and after addressed to understand the value of their participation.

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 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
skills retained for home birth delivery in emergency	Other	skills on mannequin for home birth scenario in emergency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kirkpatrick levels improvement	improvement knowledge of birth assistance (Kirkpatrick levels value)	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medical doctors and nurses

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claudio Celentano, MD	Contact	+393285577305		celentanoclaudio70@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Claudio Celentano	Recruiting	Pescara	Italia	65100	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

volunteers undergoing course for emergency home birth

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

3 months

Access Criteria

google form

URL

Not provided

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

Intervention Browse Module

MeSH Terms

ID	Term
D004636	Emergency Service, Hospital

Ancestor Terms

ID	Term
D006748	Hospital Departments
D006739	Hospital Administration
D058016	Health Facility Administration
D006268	Health Facilities

Browse Leaves

Not provided

Browse Branches

Not provided