Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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



Primary contact

Dr Sabrina Forsell


Contact details

Helsinki University Hopsital
Naistenklinikka PL140
Haartmaninkatu 2
00029 HUS

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet


Assisted delivery by vacuum extraction


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



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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Working in a Department of Gynecology and Obstetrics in a participating hospital.

Participant type


Age group




Target number of participants


Participant exclusion criteria

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)


Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Helsinki University Hospital
Department of Obstetrics and Gynecology Naistenklinikka PL140 Haartmaninkatu 2
Helsinki and Espoo
00029 HUS

Trial participating centre

Meilahti hospital
Haartmansgatan 4

Trial participating centre

Jorvi Hospital
Åbovägen 150

Sponsor information


Helsinki University Hospital

Sponsor details

Department of Gynecology and Obstetrics
Naistenklinikka PL140
Haartmaninkatu 2
00029 HUS

Sponsor type

Hospital/treatment centre



Funder type


Funder name

University of Helsinki

Alternative name(s)

Funding Body Type

Funding Body Subtype


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


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

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