Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Sabrina Forsell
ORCID ID
http://orcid.org/0000-0001-9219-9923
Contact details
Helsinki University Hopsital
Naistenklinikka PL140
Haartmaninkatu 2
Helsinki
00029 HUS
Finland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Assesment of hands-on training - effect on resident's performance and confidence in performing vacuum extraction assisted delivery - a prospective single center study
Acronym
VacuEdu
Study hypothesis
Hands-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
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
Study design
Prospective interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Assisted delivery by vacuum extraction
Intervention
All 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 type
Behavioural
Phase
Drug names
Primary outcome measure
1. 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 measures
1. 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 trial start date
01/11/2014
Overall trial end date
31/05/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients:
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.
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
400-800
Participant exclusion criteria
Patients:
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
Recruitment start date
01/01/2016
Recruitment end date
01/01/2019
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Hospital
Department of Obstetrics and Gynecology
Naistenklinikka PL140
Haartmaninkatu 2
Helsinki and Espoo
00029 HUS
Finland
Trial participating centre
Meilahti hospital
Haartmansgatan 4
Helsinki
00290
Finland
Trial participating centre
Jorvi Hospital
Åbovägen 150
Esbo
00029
Finland
Funders
Funder type
University/education
Funder name
University of Helsinki
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Dissemination of trial results will be done during the winter of 2016-2017, publication approximately in 05/2017
Intention to publish date
01/05/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list