Effect of hands-on training for residents on their performance and confidence in performing vacuum extraction assisted delivery

ISRCTN ISRCTN14881435
DOI https://doi.org/10.1186/ISRCTN14881435
Secondary identifying numbers N/A
Submission date
24/11/2015
Registration date
19/01/2016
Last edited
14/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Vaginal birth (delivery of a baby through the vagina without medical assistance) is the natural way for a baby to be born. For some women however, the final stages of labour can be extremely difficult, and so medical assistance is required. Vacuum extraction is a procedure in which a vacuum device is used in order to help to deliver a baby during the final stages of labour. This technique is considered to be a basic skill, and all residents choosing to specialise in obstetrics must learn to perform it in the early stages of their training. In Finland residents and medical students encounter and treat patients at a very early stage. The aim of this study is to look at how hands-on training affects the learning of vacuum extraction procedures and the confidence of the residents.

Who can participate?
All residents working in the maternity ward of a participating hospital that perform vacuum extractions, and their patients (new mothers).

What does the study involve?
For a period of two months, all residents are asked to complete a questionnaire immediately after they perform a vacuum extraction procedure, which is repeated one month after the procedure. This questionnaire is designed to test how well they feel they were able to perform the procedure and their level of anxiety and confidence during the procedure. Two-three days after birth, the patients (new mothers) complete a questionnaire in order to give their opinions on how they feel the procedure went and their feels surrounding the procedure.

What are the possible benefits and risks of participating?
Residents who take part could benefit from the chance to improve their vacuum extraction skills. There are no risks of residents taking part in the study. There are no specific benefits to patients taking part, although the standard risks of vacuum extraction still apply.

Where is the study run from?
Helsinki University Hospital (lead centre) and three other hospitals with maternity wards in Finland.

When is the study starting and how long is it expected to run for?
November 2014 to January 2019

Who is funding the study?
University of Helsinki (Finland)

Who is the main contact?
Dr Sabrina Forsell

Contact information

Dr Sabrina Forsell
Scientific

Helsinki University Hopsital
Naistenklinikka PL140
Haartmaninkatu 2
Helsinki
00029 HUS
Finland

ORCiD logoORCID ID 0000-0001-9219-9923

Study information

Study designProspective interventional study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleAssesment of hands-on training - effect on resident's performance and confidence in performing vacuum extraction assisted delivery - a prospective single center study
Study acronymVacuEdu
Study objectivesHands-on training on phantoms for residents can improve performance and confidence in performing vacuum extraction assisted delivery. It can also improve the experience of the mother increasing feelings of security, trust and improve communication between doctor and mother.
Ethics approval(s)Ethics Committee for Gynecology and Obstetrics, Pediatrics and Psychiatry at The Hospital District of Helsinki and Uusimaa, 24/09/2015. Ref nr 301/13/03/03/2015
Health condition(s) or problem(s) studiedAssisted delivery by vacuum extraction
InterventionAll residents participating, form the same study arm. They serve as their own controls, as evaluation is done for every vacuum extraction during one month before the intervention and one month after. The evaluations are done by self assessment, objective assessment by midwife or senior obstetrician and patient.

The residents fill out a questionnaire immediately after every performed vacuum extraction done within 1 month prior and post intervention. The patients fill in a questionnaire at the ward before release, approximately 2-3 days post-partum. At the same time they fill in the written consent for participating in the study.
Intervention typeBehavioural
Primary outcome measure1. Performance in vacuum assisted delivery is measured using an OSATS-type structured form for every performed vacuum extraction done within 1 month prior and post intervention
2. Grade of anxiety and confidence experienced by the resident using a structured questionnaire immediately after every performed vacuum extraction within 1 month prior and post intervention
3. Mother's experience of security, trust and communication during the assisted delivery a questionnaire at 2 days after delivery
Secondary outcome measures1. Vaginal tear rate is determined by reviewing patient notes of tear evaluation done immediately post-partum
2. Condition of the newborn is determined by reviewing patient notes. Evaluation of newborn is done according to general practice 1-10min post partum (Apgar points and umbilical cord blood pH).
Overall study start date01/11/2014
Completion date31/05/2019

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants400-800
Key inclusion criteriaPatients:
1. Female
2. All mothers who have had an vacuum extraction delivery performed by a resident, regardless of indication, at the delivery units of Helsinki University Hospital

Residents:
Working in a Department of Gynecology and Obstetrics in a participating hospital.
Key exclusion criteriaPatients:
1. Mothers who's vacuum extraction assisted delivery was performed by a specialist obstetrician or gynecologist
2. Inadequate language skills to fill in the form (in Finnish or Swedish)

Residents:
None
Date of first enrolment01/01/2016
Date of final enrolment01/01/2019

Locations

Countries of recruitment

  • Finland

Study participating centres

Helsinki University Hospital
Department of Obstetrics and Gynecology
Naistenklinikka PL140
Haartmaninkatu 2
Helsinki and Espoo
00029 HUS
Finland
Meilahti hospital
Haartmansgatan 4
Helsinki
00290
Finland
Jorvi Hospital
Åbovägen 150
Esbo
00029
Finland

Sponsor information

Helsinki University Hospital
Hospital/treatment centre

Department of Gynecology and Obstetrics
Naistenklinikka PL140
Haartmaninkatu 2
Helsinki
00029 HUS
Finland

ROR logo "ROR" https://ror.org/02e8hzf44

Funders

Funder type

University/education

University of Helsinki

No information available

Results and Publications

Intention to publish date01/05/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planDissemination of trial results will be done during the winter of 2016-2017, publication approximately in 05/2017
IPD sharing plan

Editorial Notes

14/02/2018: Recruitment end date was changed from 31/12/2016 to 01/01/2019, and overall trial end date was changed from 01/01/2019 to 31/05/2019.
07/02/2018: The overall trial end date was changed from 01/01/2017 to 01/01/2019, and ORCID ID was added.
This study is a follow-up study relating to trial ISRCTN15453933 which is available to view via www.isrctn.com/ISRCTN15453933.