|- candidate number||8203|
|- NTR Number||NTR2439|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jul-2010|
|- Secondary IDs||17100.3006 zonMW|
|- Public Title||Current Dutch practice on caesarean sections: Identification of barriers and facilitators for optimal care.
|- Scientific Title||Current Dutch practice on caesarean sections: Identification of barriers and facilitators for optimal care.
|- ACRONYM||SIMPLE (Caesarean section implemention study.)|
|- hypothesis||There is incomplete adherence to the recommendations from the guidelines on caesarean section among Dutch gynaecologists.|
|- Healt Condition(s) or Problem(s) studied||Implementation, Caesarean section|
|- Inclusion criteria||Previous caesarean section in a 3-4 month period.|
|- Exclusion criteria||1. Fetal congenital malformalities;|
2. Fetal death prior to delivery;
3. Duration of pregnancy less than 24 weeks of gestation.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2010|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||1000|
|- Interventions||Current care study: retrospective observational study.
Barrier and facilitatos analysis: focus group interviews among healthcare professionals and caesarean section patients.
|- Primary outcome||Adherence to the quality indicators, extracted from the guideline recommendations and the number of preventable CS.
|- Secondary outcome||1. Dutch practice as compared to international data (Robson criteria);|
2. Barriers and facilitators to perform a CS;
3. External validation of VBAC prediction model.
|- Trial web site||http://www.studies-obsgyn.nl/simple|
|- CONTACT FOR PUBLIC QUERIES||MD. MSc. S. Melman|
|- CONTACT for SCIENTIFIC QUERIES||MD. MSc. S. Melman|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Caesarean (CS) delivery rates continue to increase worldwide. In the past 20 years the CS rate in the Netherlands increased from 5 to 15%. CS have no clear benefit for overall neonatal outcome and are associated with higher maternal complications and high costs. Dutch guidelines offer clear recommendations on factors that have a direct effect on the decision to perform a CS. This study aims to provide insight into current adherence of Dutch gynaecologists to these guideline recommendations. Moreover, facilitators and barriers for guideline (non)-adherence are studied and a tailored implementation strategy will be developed and tested in a feasibility study.
The current Dutch care will be studied in 20 hospitals (N=80 gynaecologists). After the development of quality indicators 1000 files on the performed CS are analyzed regarding the adherence to the guideline recommendations. To get insight into Dutch practices compared to international data, basic obstetrical data will be extracted from the delivery database. A barrier analysis will be carried out based on the results of the current care study. Two groups of hospitals will be identified in the upper and lower extremes of the 'adherence distribution': 5 hospitals with the lowest and 5 hospitals with the highest adherence scores. Factors that determine the decision to perform a CS or not (barriers and facilitators) will be analyzed in both groups using semi-structured interviews among 15-20 health care professionals and 15-20 patients. A questionnaire will be used to study the 'prevalence' of these factors among all obstetric gynaecologists in the Netherlands and among 200 experienced patients.
Based on the outcomes of the current care study and the barrier analysis, an implementation strategy will be developed and tested. The study will be performed in 4 hospitals where the effect of the implementation strategy; the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.
|- Main changes (audit trail)|
|- RECORD||5-jul-2010 - 14-aug-2010|