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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:
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ISRCTN |
Last refreshed on:
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26 February 2018 |
Main ID: |
ISRCTN14881435 |
Date of registration:
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19/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of hands-on training for residents on their performance and confidence in performing vacuum extraction assisted delivery
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Scientific title:
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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:
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01/01/2016 |
Target sample size:
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800 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN14881435 |
Study type:
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Interventional |
Study design:
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Prospective interventional study (Treatment)
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Phase:
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Countries of recruitment
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Finland
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Contacts
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Name:
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Sabrina
Forsell |
Address:
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Helsinki University Hopsital
Naistenklinikka PL140
Haartmaninkatu 2
00029 HUS
Helsinki
Finland |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Assisted delivery by vacuum extraction Pregnancy and Childbirth Assisted delivery by vacuum extraction
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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).
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Source(s) of Monetary Support
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University of Helsinki
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Ethics review
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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
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/05/2019 |
URL:
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