|- candidate number||17645|
|- NTR Number||NTR4576|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2014|
|- Secondary IDs||2009020010 ZonMw|
|- Public Title||“Het effect van teamtraining van alle betrokken verloskundige zorgverleners in een simulatiecentrum op perinatale sterfte in Nederland.”|
|- Scientific Title||"The impact of obstetric team training on management and outcome of the Big 4 causes of perinatal mortality in the Netherlands"
|- hypothesis||Transmural multiprofessional simulation-based obstetric team training, regarding management of the BIG 4 causes of perinatal mortality will improve perinatal outcome, communication and teamwork and satisfaction of patients and care providers.|
|- Healt Condition(s) or Problem(s) studied||Perinatal outcome, Perinatal death|
|- Inclusion criteria||four hospitals will join the trial. Each hospital with surrounding primary care will form a cluster (study group). Within each cluster, teams will be formed by ambulance care providers, maternity nurses, primary midwives, obstetric nurses, secondary care midwives, residents, and gynaecologists.|
|- Exclusion criteria||none specifically|
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- planned startdate ||1-feb-2014|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||3390|
|- Interventions||multiprofessional, simulation-based obstetric team training|
|- Primary outcome||perinatal mortality and occurrence of BIG 4 disorders|
|- Secondary outcome||team performance and satisfaction of patients and health providers|
|- Timepoints||Taking into account the design effect, we need 565 deliveries per measurement period per cluster. To achieve this number we need 16 weeks for each period, adding up to a total study period of 82 weeks including a 16-week control period before the first training.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| F.R. Banga|
|- CONTACT for SCIENTIFIC QUERIES|| F.R. Banga|
|- Sponsor/Initiator ||ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Introduction: Perinatal mortality and morbidity in the Netherlands is relatively high compared to other countries in Europe. Our country has an unique system with an independent primary care providing care for low risk pregnancies and a secondary care for high risk pregnancies. Data showed that 85.2% of perinatal mortality is caused by one or more of the following disorders, the so called BIG 4: preterm delivery, small for gestational age, congenital anomaly and low Apgar score. Studies have shown that obstetric team training improves perinatal outcome and team performance. |
Objectives: The aim of this study is to improve perinatal outcome by transmural multiprofessional simulation-based obstetric team training.
Methods: 4 hospitals will join the study. Each hospital with it’s referring primary care will form a cluster (study group). Within each cluster,teams will be formed by ambulance providers, maternity nurses, primary midwives, obstetric nurses, secondary care midwives, residents, and gynaecologists, The study will be implemented in the south-eastern part of the Netherlands (Zuidoost-Brabant) consisting of nearly one million inhabitants with an annual delivery rate of over 9,000. In this area around 120 independent midwives are providing primary care. Secondary care is provided by four hospitals. Training of the study groups will be provided in a medical simulation center. A stepped wedge trial design will be employed. A stepped wedge trial is a cluster randomized trial in which all study groups (clusters) receive the intervention by a sequential roll out of the trainings over a number of time periods. The stepped wedge design by default controls for changes over time since data are collected for each measurement period for all study groups and study groups serve as a period matched control. Computerized randomization will define the sequence of the study groups.
Outcomes: Primary outcome will be perinatal mortality and occurrence of BIG 4 disorders. Secondary outcome will be team performance and satisfaction of patients and health providers.
Conclusion: The effect of transmural multiprofessional simulation-based obstetric team training has never been studied. We hypothesize that this team training will improve perinatal outcome, team performance and satisfaction of patients and care providers.
|- Main changes (audit trail)|
|- RECORD||2-mei-2014 - 1-jun-2014|