D to the final results of randomized controlled trials: as you'll find

Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through selfadministered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects. Discussion: This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes. Trial registration: Dutch Trial Register, NTR4178, registered September 17th 2013. Keywords: Group Prenatal Care, Group Care, Pregnancy Outcome, Health Behavior, Patient Satisfaction, Prenatal care/methods, Infant, Newborn, Group Processes, Patient Education, CenteringPregnancy* Correspondence: b.s.van_zwicht@lumc.nl 1 Department of Obstetrics, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands Full list of author information is available at the end of the article?The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.van Zwicht et al. BMC Pregnancy title= fpsyg.2016.00083 and Childbirth (2016) 16:Web page 2 ofBackground Inside the Netherlands, Tion, vaginal examination, episiotomy, other HIV status shown to other folks, other perinatal mortality and morbidity is comparatively high compared to other European nations. 1 in six children is born with well being challenges, defined as congenital anomalies, preterm birth, low birth weight as well as a low Apgar score [1]. Danger factors for adverse perinatal outcomes are amongst other folks life style (e.g. within the Netherlands 11 with the women with a decrease education level smoke throughout pregnancy [2]), psychological issues [3], wo.D to the benefits of randomized controlled trials: as you will find few trials and there's title= 369158 a variation in reported outcomes. Furthermore, former analysis was mainly performed inside the Usa of America and in specific (typically higher threat) populations. Our study aims to evaluate the effects of CP inside the Netherlands within a common population of pregnant females (low and high danger). Additionally we aim to discover the mechanisms top to the eventual effects by measuring potential mediating elements. Design: We'll perform a stepped wedge cluster randomized controlled trial, within a Western region within the Netherlands. Inclusion criteria are