NCT06339164

Brief Summary

Breech delivery is one of the mail topic in emergency obstetrics for Italian Board of Obstetrics and Gynecology. Formal frontal lecture and digital learning represent nowadays the two typical learning methods. A bedside evaluation it's not feasible due to rarity of such emergency, due to the common senior physicians involvement when it occurs, and due to medico-legal risks. Mannequin scenario represents the best way of skill evaluation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 24, 2024

Last Update Submit

March 24, 2024

Conditions

Breech Presentation; Before Labor

Keywords

breech, learning, mannequin

Outcome Measures

Primary Outcomes (2)

  • Skills capacities

    Skills at the scenario (maneuvers). Deriving form charts recorded during the scenario and time enalpsed

    1 months

  • Skills capacities

    Skills at the scenario evaluated for 5 supervisors

    1 month

Secondary Outcomes (1)

  • learning qualities

    1 month

Study Arms (2)

Formal lecture

residents undergoing frontal lecture one month before the scenario

Other: skills and learning quality in breech delivery

Digital learning

residents learning digitally the topic for at least one month before the scenario

Other: skills and learning quality in breech delivery

Interventions

skills and learning quality in breech deliveryOTHER

evaluation of different skill retention and learning quality after different learning methods

Digital learningFormal lecture

Eligibility Criteria

Age24 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

all residents undergoing lecture for obstetric emergencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Celentano

Pescara, PE, 65100, Italy

Location

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Claudio Celentano, MD

CONTACT

+39 3285577305celentanoclaudio70@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 1, 2024

Study Start

April 15, 2024

Primary Completion

May 15, 2024

Study Completion

June 30, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

questionnaire on Goggle forms

Locations

IT(1)