Condition category
Pregnancy and Childbirth
Date applied
24/11/2015
Date assigned
19/01/2016
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 2017

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

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 measures

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

01/01/2017

Reason abandoned

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

31/12/2016

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

Sponsor information

Organisation

Helsinki University Hospital

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

This study is a follow-up study relating to trial ISRCTN15453933 which is available to view via www.isrctn.com/ISRCTN15453933.