NCT05605626

Brief Summary

Evaluation of different learning programs on persistence of skills in operative vaginal delivery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

March 26, 2022

Last Update Submit

October 30, 2022

Conditions

Birth DisorderDelivery Complication

Keywords

vaginal birthvacuum deliveryoperative vaginal birthmannequin training program

Outcome Measures

Primary Outcomes (1)

  • improving and retaining skills in two different groups of teaching programs

    evaluate video recorded simulations using items and total value during the operative vaginal delivery on manequin

    12 weeks and 1 year

Secondary Outcomes (1)

  • improve skills in obstetric emergencies considering year of formation and teaching programs

    12 weeks and 1 year

Study Arms (2)

Simulator training before

group exposed directly to simulator training without knowing the topic of obstetric emergency

Other: the better retaining of skills

lesson before simulation training

group undergoing formal lecture before the vacuum delivery simulation on mannequin

Other: the better retaining of skills

Interventions

the better retaining of skillsOTHER

identify which teaching program has the better retaining of skills

Simulator training beforelesson before simulation training

Eligibility Criteria

Age25 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale/female rate NS in two groups
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

participants were residents in ObGyn or young specialists in ObGyn (less than 5 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chieti

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

November 4, 2022

Study Start

June 15, 2021

Primary Completion

October 30, 2021

Study Completion

April 1, 2022

Last Updated

November 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Simulation in EASC

Locations

IT(1)