Design and outline of the Healthy Pregnancy 4 All study

BMC Pregnancy and Childbirth, Jul 2014

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.

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Design and outline of the Healthy Pregnancy 4 All study

BMC Pregnancy and Childbirth Design and outline of the Healthy Pregnancy 4 All study Semiha Denkta 0 1 Jashvant Poeran 0 Sabine F van Voorst 0 Amber A Vos 0 Lieke C de Jong-Potjer 0 Adja JM Waelput 0 Erwin Birnie 0 3 Gouke J Bonsel 0 2 4 Eric AP Steegers 0 0 Department of Obstetrics and Gynecology, Division of Obstetrics & Prenatal Medicine, Erasmus MC , PO Box 2040, 3000 CA Rotterdam , The Netherlands 1 Department of Social Sciences, Erasmus University College, Erasmus University Rotterdam , PO Box 1738, 3000 DR Rotterdam , The Netherlands 2 Department of Public Health, Erasmus MC , PO Box 2040, 3000 CA Rotterdam , The Netherlands 3 Institute of Health Policy and Management, Erasmus University Rotterdam , PO Box 1738, 3000 DR Rotterdam , The Netherlands 4 Rotterdam Midwifery Academy , 'Rochussenstraat building', PO Box 2040, 3000 CA Rotterdam , The Netherlands 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. Cohort study; Randomized controlled trial; Preconception care; Antenatal care; Public health; Epidemiology; Pregnancy; Neighbourhood; Care pathway - Table 1 Demographic characteristics of the study population by yes/no G4-cities (the four largest cities) with percentages in brackets NETHERLANDS MINUS G4-CITIES TOTAL 245445 (100.0) 1338420 (100.0) 121592 (49.5) 607953 (45.4) 123853 (50.5) 730467 (54.6) 139786 (57.0) 1186772 (88.7) 105659 (43.0) 151648 (11.3) 6987 (2.8) 19861 (1.5) 34864 (14.2) 127013 (9.5) 61354 (25.0) 395138 (29.5) 85444 (34.8) 535927 (40.0) 56796 (23.1) 260481 (19.5) 145367 (59.2) 254607 (19.0) 58641 (23.9) 853074 (63.7) 41437 (16.9) 230739 (17.2) 165658 (67.5) 1320392 (98.7) 79787 (32.5) 18028 (1.3) 33159 (2.5) 81646 (6.1) 15673 (6.4) 27724 (11.3) 125175 (9.4) 3385 (1.4) 14818 (1.1) 6718 (0.5) 2126 (0.2) 3547 (0.3) 12391 (0.9) 729545 (46.1) 854320 (53.9) 1326558 (83.8) 257307 (16.2) 26848 (1.7) 161877 (10.2) 456492 (28.8) 621371 (39.2) 317277 (20.0) 399974 (25.3) 911715 (57.6) 272176 (17.2) 1486050 (93.8) 97815 (6.2) 38392 (2.4) 97319 (6.1) 152899 (9.7) 18203 (1.1) 8196 (0.5) 2584 (0.2) 4308 (0.3) 15088 (1.0) No. of pregnancies during study period Primiparous Multiparous Non-Western Maternal age < 20 years 20-24 years 25-29 years 30-34 years 35 years Socioeconomic status score Neighbourhood Non-deprived Perinatal outcomes** Congenital anomalies 5233 (2.1) Preterm birth Apgar score <7 (5 minutes after birth) Any Big4** Fetal mortality Intrapartum mortality 458 (0.2) Neonatal mortality Perinatal mortality 1478 (0.6) 761 (0.3) 2697 (1.1) 50267 (20.5) 242697 (18.1) 292964 (18.5) **Individual Big4 morbidities do not add up to any Big4. as women can have >1 Big4 morbidity. From 22 weeks of gestational age. 07 days postpartum. Total of fetal, intrapartum and neonatal mortality. 1st antenatal booking 14W ABS STND INEQ Congenital anomalies STND 10 10 10 10 9 5 10 2 3 3 4 6 8 8 7 9 4 1 1 2 4 9 8 4 5 3 5 7 7 1 5 6 3 6 9 2 8 5 9 2 1 10 10 10 10 9 4 9 2 1 3 4 7 7 5 7 9 5 2 1 3 3 8 8 5 6 2 7 8 5 2 4 6 4 5 9 2 8 6 10 1 1 3 3 2 4 6 10 1 5 9 9 2 4 3 7 1 7 4 10 6 7 10 3 6 10 6 8 6 7 7 10 8 8 8 4 1 9 1 1 1 8 7 3 6 9 10 8 4 7 2 9 4 5 1 1 6 2 5 1 9 4 2 10 2 8 2 7 6 10 7 10 5 8 5 10 8 1 2 1 4 3 9 5 2 7 8 10 9 4 7 2 9 5 5 1 2 6 3 6 1 9 4 1 10 1 7 2 8 6 10 7 10 4 8 5 10 8 1 2 1 3 5 9 4 Perinatal mortality/all women Perinatal mortality/Big4 morbidities 1 Amsterdam 2 Rotterdam 3 Den Haag 4 Utrecht 5 Eindhoven 6 Tilburg 7 Almere 8 Groningen 9 Breda 10 Nijmegen 11 Enschede 12 Apeldoorn 13 Haarlem 14 Arnhem 15 Zaanstad 16 Amersfoort 17 Haarlemmermeer 18 's-Hertogenbosch 19 Zoetermeer 20 Zwolle 21 Maastricht 22 Dordrecht 23 Leiden 24 Emmen 25 Ede 26 Venlo 27 Westland 28 Deventer 29 Delft 30 Sittard-Geleen 31 Leeuwarden 32 Alkmaar 33 Heerlen 34 Helmond 35 Hilversum 36 Sdwest Frysln 37 Amstelveen 38 Hengelo 39 Purmerend 40 Roosendaal 8 10 9 9 5 8 8 7 3 10 9 8 4 9 2 10 4 6 1 6 8 2 4 2 7 3 1 9 1 3 5 2 7 5 7 7 1 5 2 2 6 10 8 9 5 8 10 9 4 10 9 8 6 4 1 10 3 5 1 2 7 1 2 2 4 2 2 9 1 1 5 2 8 4 5 7 1 7 3 5 9 3 7 2 4 6 3 1 7 4 4 8 8 9 1 5 7 3 2 5 8 3 9 1 9 10 8 3 5 7 10 10 6 8 2 10 10 5 9 2 8 6 6 9 2 4 5 8 2 10 8 9 5 9 2 10 7 4 1 8 3 2 3 3 9 3 1 7 1 1 5 4 1 4 10 10 7 6 5 1 7 7 7 10 2 5 8 9 4 10 6 8 6 6 1 10 6 4 1 4 2 1 2 3 5 1 1 5 1 1 5 3 2 3 8 10 5 6 4 2 5 9 8 6 8 9 7 1 8 6 8 4 2 2 6 1 1 7 7 1 9 4 5 6 3 10 7 10 10 9 5 4 10 8 3 1 1 4 9 10 Abbreviations ABS: Absolute rate; HP4All: Healthy Pregnancy 4 All; INEQ: Inequality rate; PCC: Preconception care; PRN: Perinatal registry netherlands; R4U: Rotterdam reproductive risk reduction; SES: Socio-economic status; SGA: Small for gestational age; STND: Standardized rate. Competing interests The authors declare that they have no competing interests. Authors contributions All authors were involved in conception and design of the study. SD, JP, SvV, and AV drafted the manuscript. All authors participated in the design of the study during several meetings. All authors edited the manuscript and read and approved the final manuscript. Funding The research proposal was reviewed and funded by the Ministry of Health, Welfare and Sports of the Dutch Government: grant 318804. 1. Zeitlin JR , Mohangoo A : European perinatal health report 2008. EURO-PERISTAT project in collaboration with SCPE , EUROCAT and EURONEONET; 2008 . Available from: www.europeristat.com. 2. Buitendijk SE , Nijhuis JG : [High perinatal mortality in the Netherlands compared to the rest of Europe] . Nederlands tijdschrift voor geneeskunde 2004 , 148 ( 38 ): 1855 - 1860 . 3. Mohangoo AD , Buitendijk SE , Hukkelhoven CW , Ravelli AC , Rijninks-van Driel GC , Tamminga P , Nijhuis JG : [Higher perinatal mortality in The Netherlands than in other European countries: the Peristat-II study] . Nederlands tijdschrift voor geneeskunde 2008 , 152 ( 50 ): 2718 - 2727 . 4. de Graaf JP , Ravelli AC , de Haan MA , Steegers EA , Bonsel GJ : Living in deprived urban districts increases perinatal health inequalities . J Matern Fetal Neonatal Med 2013 , 26 ( 5 ): 473 - 481 . 5. Jaddoe VW , van Duijn CM , Franco OH , van der Heijden AJ , van Iizendoorn MH , de Jongste JC , van der Lugt A , Mackenbach JP , Moll HA , Raat H , Rivadeneira F , Steegers EA , Tiemeier H , Uitterlinden AG , Verhulst FC , Hofman A : The Generation R Study: design and cohort update 2012 . Eur J Epidemiol 2012 , 27 ( 9 ): 739 - 756 . 6. van Eijsden M , Vrijkotte TG , Gemke RJ , van der Wal MF : Cohort profile: the Amsterdam Born Children and their Development (ABCD) study . 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Semiha Denktaş, Jashvant Poeran, Sabine F van Voorst, Amber A Vos, Lieke C de Jong-Potjer, Adja JM Waelput, Erwin Birnie, Gouke J Bonsel, Eric AP Steegers. Design and outline of the Healthy Pregnancy 4 All study, BMC Pregnancy and Childbirth, 2014, 253, DOI: 10.1186/1471-2393-14-253