NCT05921045

Brief Summary

Learning skills on shoulder dystocia on doctor and midwife

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

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

January 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 1, 2024

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

June 8, 2023

Last Update Submit

January 30, 2024

Conditions

Shoulder Dystocia - DeliveredBirth Disorder

Keywords

emergency deliveryShoulder dystociamannequin

Outcome Measures

Primary Outcomes (1)

  • Management of SD

    incidence of personal management of SD and fetal and neonatal outcomes in previous experiences and in successive

    6 months

Secondary Outcomes (2)

  • Clinical approach in labor ward in identification and management of SD (with previous SD)

    6 months

  • Clinical approach in labor ward in identification and management of SD (without previous SD)

    6 months

Study Arms (1)

time 0 and 6 months answers

questionnaire answers after first training and after re-training on shoulder dystocia model

Other: modification of clinical approach in clinical practice at time 0Other: modification of clinical approach in clinical practice at 6 months

Interventions

modification of clinical approach in clinical practice at time 0OTHER

evaluation of modification in clinical approach after training

Also known as: questionnaire for evaluation of modification in clinical approach
time 0 and 6 months answers
modification of clinical approach in clinical practice at 6 monthsOTHER

evaluation of modification in clinical approach after retraining

Also known as: questionnaire for evaluation of modification in clinical approach
time 0 and 6 months answers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

residents specialists midwies

You may qualify if:

  • residents and specialists in obstetrics and gynecology
  • midwives

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claudio Celentano

Pescara, Italia, 65100, Italy

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesShoulder Dystocia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Claudio Celentano, MD

    EASC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 8, 2023

First Posted

June 27, 2023

Study Start

January 1, 2023

Primary Completion

December 30, 2023

Study Completion

December 31, 2023

Last Updated

February 1, 2024

Record last verified: 2023-07

Locations

IT(1)