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Open Access Study protocol

Design and outline of the Healthy Pregnancy 4 All study

Semiha Denktaş15*, Jashvant Poeran1, Sabine F van Voorst1, Amber A Vos1, Lieke C de Jong-Potjer1, Adja JM Waelput1, Erwin Birnie12, Gouke J Bonsel134 and Eric AP Steegers1

Author Affiliations

1 Department of Obstetrics and Gynecology, Division of Obstetrics & Prenatal Medicine, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, The Netherlands

2 Institute of Health Policy and Management, Erasmus University Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands

3 Department of Public Health, Erasmus MC, PO Box 2040, 3000 CA Rotterdam, The Netherlands

4 Rotterdam Midwifery Academy, ‘Rochussenstraat building’, PO Box 2040, 3000 CA Rotterdam, The Netherlands

5 Department of Social Sciences, Erasmus University College, Erasmus University Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands

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BMC Pregnancy and Childbirth 2014, 14:253  doi:10.1186/1471-2393-14-253

Published: 31 July 2014

Abstract

Background

Promotion of healthy pregnancies has gained high priority in the Netherlands because of the relatively unfavourable perinatal health outcomes. In response a nationwide study Healthy Pregnancy 4 All was initiated. This study combines public health and epidemiologic research to evaluate the effectiveness of two obstetric interventions before and during pregnancy: (1) programmatic preconception care (PCC) and (2) systematic antenatal risk assessment (including both medical and non-medical risk factors) followed by patient-tailored multidisciplinary care pathways. In this paper we present an overview of the study setting and outlines. We describe the selection of geographical areas and introduce the design and outline of the preconception care and the antenatal risk assessment studies.

Methods/design

A thorough analysis was performed to identify geographical areas in which adverse perinatal outcomes were high. These areas were regarded as eligible for either or both sub-studies as we hypothesised studies to have maximal effect there. This selection of municipalities was based on multiple criteria relevant to either the preconception care intervention or the antenatal risk assessment intervention, or to both. The preconception care intervention was designed as a prospective community-based cohort study. The antenatal risk assessment intervention was designed as a cluster randomised controlled trial – where municipalities are randomly allocated to intervention and control.

Discussion

Optimal linkage is sought between curative and preventive care, public health, government, and social welfare organisations. To our knowledge, this is the first study in which these elements are combined.

Keywords:
Cohort study; Randomized controlled trial; Preconception care; Antenatal care; Public health; Epidemiology; Pregnancy; Neighbourhood; Care pathway