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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 26 February 2018
Main ID:  ISRCTN14881435
Date of registration: 19/01/2016
Prospective Registration: No
Primary sponsor: Helsinki University Hospital
Public title: Effect of hands-on training for residents on their performance and confidence in performing vacuum extraction assisted delivery
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
Date of first enrolment: 01/01/2016
Target sample size: 800
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN14881435
Study type:  Interventional
Study design:  Prospective interventional study (Treatment)  
Phase: 
Countries of recruitment
Finland
Contacts
Name: Sabrina    Forsell
Address:  Helsinki University Hopsital Naistenklinikka PL140 Haartmaninkatu 2 00029 HUS Helsinki Finland
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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.

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Assisted delivery by vacuum extraction
Pregnancy and Childbirth
Assisted delivery by vacuum extraction
Intervention(s)
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.
Primary Outcome(s)
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(s)
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).
Secondary ID(s)
N/A
Source(s) of Monetary Support
University of Helsinki
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
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
Results
Results available: Yes
Date Posted:
Date Completed: 31/05/2019
URL:
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