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Implementation of the external cephalic version in breech delivery.
Dutch national implementation study of external cephalic version.



- candidate number6018
- NTR NumberNTR1878
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-jun-2009
- Secondary IDs80-82315-98-09011  ZonMW
- Public TitleImplementation of the external cephalic version in breech delivery.
Dutch national implementation study of external cephalic version.
- Scientific TitleImplementation of the external cephalic version in breech delivery.
Dutch national implementation study of external cephalic version.
- ACRONYMN/A
- hypothesisThe aim of this study is to assess barriers and facilitators of implementation of external cephalic version in The Netherlands, and to develop an innovative implementation strategy based on improved patient counselling and information of health care providers as cornerstones.
- Healt Condition(s) or Problem(s) studiedBreech presentation, external cephalic version, Counseling
- Inclusion criteriaThe proposal will contain three phases. In the first phase, we will identify facilitators and barriers of implementation of ECV. Subsequently, we will develop an implementation strategy targeted on patient counselling and information of health care providers, and evaluate the cost-effectiveness of the developed strategy.
All hopsitals in midwife practices in The Netherlands are potential candidates for the randomized controlled trial of the implementation developes model.
- Exclusion criteriaN/A
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2009
- planned closingdate1-dec-2013
- Target number of participants50
- InterventionsIn the first two phases of the study, a omplementation plan will be developed. The regions of the participating hospitals will be randomized either to the control group, or to the group starting to work with the implementation plan.
- Primary outcomePrimary endpoint is the number of patients that has an ECV performed.
- Secondary outcomeSecondary endpoints are guidelines’ adherence rates, complications at ECV, the number of children that is in cephalic position at delivery, the number of caesarean sections and the perinatal condition of mother and child. Moreover, we will assess patient knowledge (e.g. ECV, breech delivery, caesarean section), patient decisional conflict and patient satisfaction. We will also calculate costs of both implementation interventions and medical interventions. In case one or both implementation interventions are effective, their cost-effectiveness will be assessed.
- TimepointsThe first fase will be completed at the end 0f 2009 and results will be reported to Zon MW. After permission, the second and third fase will be accomplished.
- Trial web sitehttp://www.studies-obsgyn.nl/home/page.asp?page_id=354
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, MSc F. Vlemmix
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBreech presentation occurs in 3 to 4 % of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the The Royal Dutch Organisation for Midwives (KNOV) and The Dutch Society for Obstetrics and Gynaecology (NVOG). Implementation of ECV does not exceed 50 to 60% and probably less.
The aim of this study is to assess barriers and facilitators of implementation of ECV in The Netherlands, and to develop an innovative implementation strategy based on improved patient counselling and information of health care providers as cornerstones.
The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV. The first fase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to:
1. Inform and counsel pregnant women with a breech presentation;
2. Inform and education of the care providers.
In the third fase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices.
Secondary endpoints are process indicators, the amount of children in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured.
- Main changes (audit trail)
- RECORD26-jun-2009 - 6-okt-2009


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