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Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2020-042423 review only Article Type: Protocol

Date Submitted by the 04-Jul-2020 Author:

Complete List of Authors: Kaforau, Lydia; NRH , Pediatrics and Neonatal Care, National Referral Hospital ; Curtin University Faculty of Health Sciences, Curtin University Tessema, Gizachew; Curtin University Bentley Campus, School of Public Health Jancey, Jonine; Curtin University, Western Australian Centre for Health Promotion Research, School of Public Health Dhamrait, Gursimran; Telethon Kids Institute, ; The University of Western Australia Faculty of Health and Medical Sciences, School of Population and Global Health Bugoro, Hugo ; Solomon Islands National University, Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University Pereira, G.F; Curtin University, Centre for Fertility and Health (CeFH), Norwegian Institute of Public Health; Curtin University Bentley Campus,

School of Public Health http://bmjopen.bmj.com/

Maternal medicine < OBSTETRICS, Fetal medicine < OBSTETRICS, Keywords: PERINATOLOGY

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1 2 3 Manuscript 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping 7 review protocol. 8 9 Lydia S.K. Kaforau,1,2 Gizachew A. Tessema,2,3 Jonine Jancey,2 Gursimran K. Dhamrait,4,5 10 Hugo Bugoro,6 Gavin Pereira,2,4,7 11 12 1Department of Paediatrics and Neonatal Care, National Referral Hospital, Solomon Islands 13 2 14 School of Public Health, Curtin University, Western Australia, Perth, Australia. 15 3School of Public Health, the University of Adelaide, South Australia, Adelaide, Australia. 16 4Telethon Kids Institute, Nedlands, Western Australia, Perth, Australia. 17 5School of Population and Global Health, The University of Western Australia, Nedlands, 18 Western Australia, ForAustralia. peer review only 19 6Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University. 20 7 21 Centre for Fertility and Health (CeFH), Norwegian Institute of Public Health, Oslo, Norway. 22 23 Address correspondence to: 24 Lydia S.K. Kaforau 25 School of Public Health, Curtin University, 26 400 Kent St, Bentley Western Australia, 6102 27 Email: [email protected] 28 29 Phone: +61 433 956 543 30 31 Main Body Word Count: 2030 32 33 Abstract Word Count: 245 34 35 Short Title: Risk factors of adverse birth outcomes 36

37 http://bmjopen.bmj.com/ 38 Abbreviations: 39 CINAHL-cumulative index to nursing and allied health 40 LBW- low birth weight 41 LMICs - low- and middle-income countries 42 PRISMA- preferred reporting items for systematic reviews and meta-analyses 43 44 SGA- small for gestational age

45 on October 1, 2021 by guest. Protected copyright. 46 Keywords: 47 Adverse Birth Outcomes 48 Low Birth Weight 49 Preterm Birth 50 Risk Factors 51 52 Pacific Island region 53 54 55 56 57 58 59 60

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1 2 3 ABSTRACT 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Introduction 7 Fetal growth restriction, preterm birth and stillbirth are adverse birth outcomes that are 8 prevalent in low- and middle-income settings such as the Pacific Island region. It is widely 9 accepted that the excess burden of adverse birth outcomes is attributable to socio-economic 10 and environmental factors that predispose families to excess risk. Our review seeks to 11 determine the prevalence and identify the major risk factors of adverse birth outcomes in the 12 Pacific Island region. 13 14 15 Methods 16 This scoping review will follow the five-staged Arksey and O’Malley’s framework and 17 consultation with Solomon Islands’ health stakeholders. A preliminary literature review was 18 undertaken to understandFor the peer scope of the review review. We will onlyuse MeSH and keyword terms for 19 adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest, and Springer Link 20 st 21 databases for articles published from 1 January 2000. Subsequent searches will use google 22 scholar and the internet browser to world health organisations and regional health 23 organisation for published and unpublished reports for non-indexed studies. All articles 24 retrieved will be managed with software such as Endnote. Eligible studies will be screened 25 using PRISMA flow chart for final selection. The results will be presented as numerical and 26 thematic summaries that maps risk factors and prevalence to the population and cultures of 27 the Pacific Island region. 28 29 30 Ethics and Dissemination 31 Formal ethical approval is not required as primary or administrative data will not be 32 collected. The findings of this study will be published in peer-reviewed journals and 33 presented in national and regional conferences. 34 35 36

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1 2 3 Article Summary 4 5  This is a protocol for a scoping review on the prevalence and risk factors of adverse BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 birth outcomes in the Pacific Island region 7 8 Strengths and limitations of this study 9 10  The prevalence of adverse birth outcomes and their risk factors in the Pacific Island 11 region are not well-established. The review will fill this knowledge gap. 12 13  The review will provide evidence to help inform improvements in perinatal health, set 14 health service priorities, target interventions, and allocate resources to where they are 15 needed. 16  Few studies on the topic might not be retrieved due to limited research activity and 17 lack of electronic dissemination of public health information in the region. However, 18 this in itself Foris an important peer finding review to initiate and publishonly such research. In addition, a 19 20 stakeholder consultation stage will be included in the review. 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

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1 2 3 INTRODUCTION 4 5 Despite improvements in medical care and technology, the incidence of adverse birth BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 outcomes remains a significant public health issue, particularly in low and middle-income 7 countries (LMICs).1 2 Adverse birth outcomes include indicators for early gestation (preterm 8 birth), fetal growth restriction and perinatal mortality. Preterm birth is the most well-accepted 9 10 benchmark for morbidity attributable to early gestation and is defined as birth before 37 2 11 weeks of completed gestation. In LMICs, fetal growth restriction is indicated by its proxies 12 ascertained at birth.3 These proxies include term low birth weight (LBW); defined as birth 13 weight <2,500 grams from 37 weeks of completed gestation, and small for gestational age 14 (SGA); defined as weight in the lowest 10th centile for gestational age and sex or as a 15 multiple of standard deviations from the sex-specific population mean weight. In LMICs, 16 LBW is also historically used as a proxy for preterm birth given the lack of information on 17 4 5 18 gestational length. For Fetal growth peer restriction review is associated withonly infant mortality and 1 2 19 morbidity. Stillbirth is the most commonly investigated mortality-related outcome and is 20 defined as birth without signs of life from 28 weeks of completed gestation.1 Both preterm 21 birth and fetal growth restriction can significantly impact longer-term physiological 22 complications and wellbeing of children6 7 and are major risk factors for stillbirth. 23 24 The aetiologies of adverse birth outcomes are multifactorial and not entirely well 25 understood.1 Evidence from studies conducted elsewhere shows that socioeconomic, health, 26 obstetric and biological factors are linked with adverse birth outcomes in high income 27 countries as well as LMICs.2 6 8-10 Moreover, evidence has also shown that environmental 28 (non-genetic) risk factors are relatively more prevalent in LMICs given the higher infant 29 6 7 30 mortality and morbidity in these countries. More than 96% percent of the 32 million LBW 8 31 infants born globally each year occur in LMICs. Although adverse birth outcomes are 32 reasonably well documented in some LMICs, such as India,11 studies in the Pacific Island 33 region remain sparse. 34 35 The Pacific Island region broadly refers to a group of countries and territories that border the 36 Pacific Ocean.12 The region, defined here as the LMICs and territories within the Melanesian, 37 Polynesian and Micronesian sub-regions, are culturally and ethnically diverse, with varying http://bmjopen.bmj.com/ 38 degrees of economic development and living standards.12 The indigenous populations of the 39 region are typically overrepresented in national and global scales for disease burden for both 40 communicable and non-communicable diseases.12 Health indicators also vary considerably 41 42 across this region; for example, the infant mortality rate in Papua New Guinea is 50 per 1,000 13 43 births compared to 20 per 1,000 births in Fiji. Similarly, LBW and SGA also vary within 44 and between countries of the region with reported prevalence inconsistent and under- 45 reported.14 A review in 2013 estimated a period prevalence of 8% for preterm birth, 10% for on October 1, 2021 by guest. Protected copyright. 46 LBW and 19% for SGA in the broader region of Oceania,15 but these prevalence are not well- 47 established for the Pacific Island region specifically. Moreover, although it is estimated that 48 98% of stillbirths occur in LMICs,16 there are no high-quality estimates for stillbirth 49 50 prevalence in the Pacific Island region. In the last two decades, there are substantial decline 51 in infant and child mortality by approximately 50% in more than half of the pacific Island 52 countries and territories.14 However, the extent of such improvements remains uncertain due 53 to poor data quality and coverage and impacting cultural factors. 54 55 Deficiency in the provision of basic health services such as antenatal care and delivery 56 services, infrastructure, telecommunication and transportation are pertinent contributors to 57 the burden of adverse birth outcomes in the Pacific Island region.17 Notably, more than 60% 58 of the population in the region live in rural areas.18 Factors such as access to health care, diet 59 and substance use vary considerably. There is some indication that levels of alcohol 60

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1 2 3 consumption, and tobacco, and substance use (including Betel or Areca nut) may be among 4 19-23

the highest globally. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 The aim of this scoping review is to synthesise available results from studies on the 7 prevalence and risk factors of adverse birth outcomes in the Pacific Island region. Knowledge 8 of the burden of adverse birth outcomes and key risk factors will provide policy makers and 9 10 healthcare practitioners working in the region with evidence that can be used to inform 11 strategies to achieve reductions in adverse birth outcomes and improve overall perinatal 12 health. These research findings will help to design targeted interventions and better allocate 13 resources to where they are needed. Additionally, findings of the review will inform future 14 aetiological research on the effect of risk factors of adverse birth outcomes in the region. 15 16 METHODS 17 This scoping review will follow the Joanna Briggs Institute Reviewers Manual24 derived from 18 For peer review only 25 19 Arksey and O’Malley’s five-staged methodological Framework . Briefly, this includes 20 explicit specification of research questions, reproducible methods to identify relevant studies, 21 transparent declarations of inclusion and exclusion criteria, documented collation of data, and 22 standardised summarisation and reporting of results. We will also include an optional stage 23 six of stakeholder consultation for additional insights. Our reporting will also compliant with 24 Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping 25 reviews checklist.24 26 27 Stage one: Specification of the research question. 28 We will first identify the research question. A preliminary literature review was undertaken to 29 understand the extent of literature on exposures of risk factors of adverse birth outcomes in 30 31 the Pacific Island region. This stage will identify evidence gaps and inform the formulation of 32 the research questions for future studies. The broad research question is What is the 33 prevalence of the adverse birth outcomes and what are the major types of risk factors 34 relevant to the selected adverse birth outcomes in the Pacific Island region? The indigenous 35 population of the region are broadly classified as Melanesian, Polynesian and Micronesians, 36 each with their own diverse historical roots and cultures.12 Such diversity is accompanied by http://bmjopen.bmj.com/ 37 differences in economic development and living standards causing wide variation in health 38 12 39 outcomes between populations. Consequently, this review will also describe the prevalence 40 and risk factors by sub-population group. 41 42 Stage two: Identifying relevant studies 43 The second stage of the review aims to identify the relevant studies through the eligibility 44 criteria, and search strategies involved. The Arksey and O’Malley’s methodological on October 1, 2021 by guest. Protected copyright. 45 25 46 framework uses Population-Concept-Context. For this review the Population is defined as 47 all mothers who gave birth in the Pacific Island region and children from these births; 48 Concept is the prevalence and risk factors for adverse birth outcomes; and Context is defined 49 geographically as all 21 countries and territories in the region. 50 51 Inclusion and exclusion criteria 52 We will include all studies and articles that report risk factors and their associations with one 53 54 or more of the adverse birth outcomes in the Pacific Island region. We will include studies 55 from the 21 sovereign island states and territories of the region namely: American Samoa, 56 Cook Islands, Easter Islands, Federated States of Micronesia, Fiji, Guam, Kiribati, Mariana 57 Islands, Marshall Islands, Nauru, New Caledonia, Niue, Palau, Papua New Guinea, Samoa, 58 Solomon Islands, Tahiti, Tokelau, Tonga, Tuvalu, Vanuatu and Wallis and Futuna.14 Both 59 primary and secondary analytical studies published in peer-reviewed journals and grey 60

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1 2 3 literature as government reports will be included. Studies published in English from the year 4

2000 until the present will be included. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 Search Strategy 7 The search strategy will follow the three-stage search process outlined by the Joanna Briggs 8 Institute.26 The first stage will include an initial search that will be made in CINAHL and 9 10 Medline to identify MeSH or text terms contained within the titles and abstracts of articles 11 from the key words displayed in Table one. In the second stage of the search, all MeSH terms 12 and/or synonyms will then be applied across the selected databases and combined with 13 Boolean operators, truncations, and wildcards. The following electronic databases will be 14 searched: CINAHL, Medline, ProQuest, SpringerLink and Scopus. In this stage, we will 15 carry out two levels of searches. The first level will use general key MeSH terms and their 16 synonyms of pregnancy risk factors, adverse birth outcomes and Pacific Island region. The 17 18 general search stringFor will be peerdefined as: (adversereview pregnancy only outcomes OR poor pregnancy 19 outcomes OR adverse birth outcomes OR poor birth outcomes OR preterm birth OR fetal 20 growth restriction OR low birth weight OR stillbirth) AND (pregnancy risk factors OR 21 pregnancy risk*) AND (Pacific Island* OR Oceania OR South Pacific Island*). Similarly, a 22 specific search with more precise key terms or specific risk factors will narrow the search 23 down for each country. Specific search terms will be identified through the initial literature 24 review to understand the specific risk factors within the population. The specific key terms 25 26 for risk factors will be defined as: malaria OR anaemia OR substance use OR alcohol OR 27 betel nut OR areca nut OR tobacco. The above specific terms will be combined with a term to 28 identify each individual country within the region. We will also assess the reference list of 29 studies initially retrieved in order to identify any relevant studies which have not been 30 identified by the electronic database searches. Additional searches will also be conducted to 31 identify non-indexed studies and manually searching thesis repositories, Google Scholar and 32 33 Google for regional health organisation websites. 34 Stage three: Study selection 35 At this stage we will screen and select the studies. During the primary review we will 36

consolidate all studies retrieved, remove all duplicates and remove studies that do not http://bmjopen.bmj.com/ 37 27 38 correspond to the Population Concept Context criteria. Next, we will screen the titles and 39 abstracts of articles after importing all records retrieved from databases and web-based 40 searches into EndNote. Any uncertainty with the title and abstract will go through full-text 41 review. Any uncertainty reached on any article will be discussed with the broader research 42 team. If consensus is not reached, articles will be excluded from the review. All remaining 43 articles will go through full-text screening, following the PRISMA flow chart28 and final 44

45 articles will proceed to the final review. on October 1, 2021 by guest. Protected copyright. 46 47 Stage four: Charting data 48 Data charting will involve data extraction and documenting from the final articles selected. 49 During the data extraction, all results will be entered into Excel spreadsheets alongside 50 standard bibliographic information that includes author(s), year of publication, origin or 51 country of origin, aims and purpose, study population, methodology, intervention type, 52 53 intervention duration, outcomes and details and key findings.(Table two outlines the standard 54 bibliographic information) For each article reviewed key information to be retrieved will be 55 risk factors matched to birth outcomes, prevalence to the specific context of the region. The 56 framework will be pilot tested by the reviewers to ensure that it is consistent with data 57 charting and the study aims and objectives. Charting of data will be an iterative process of 58 screening and extracting data that will be done mostly by the principal investigator. Any 59 60

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1 2 3 arising questions and uncertainty during the process will be discussed research team to reach 4

an agreement. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 7 Stage five: Collating, summarising, and presenting the results 8 In stage five, the results of the scoping review will be presented as a map of data extracted 9 from the selected journals and articles. Findings will be presented quantitatively in 10 aggregated forms as figures, tables and qualitatively as narrative summaries reflective of the 11 study objectives as outlined by Arksey and O’Malley.25 We expect to map a wide range of 12 risk factors, prevalence, and the different adverse birth outcomes against the countries’ 13 14 ethnic, and geographical diversity to provide the first such body of literature for the region. 15 16 Stage six: Stakeholder consultation 17 A consultation exercise will be conducted online with relevant health professionals in the 18 Solomon Islands includingFor midwives,peer paediatric review nurses, obstetricians, only and paediatricians. 19 This stage aims to validate findings from this study and to add additional insights and 20 21 recommendations from their perspectives. Ten health professionals working with pregnant 22 woman and infants will be consulted. Selection will be done by purposeful and snowball 23 sampling. 24 25 CONCLUSION 26 27 The Pacific Island region is significantly under-studied compared to other low-income 28 29 regions of the world. Context-specific benchmark measures of adverse birth outcomes and 30 identification of their risk factors is fundamental to describe population level burden and 31 initiate processes for treatment, antenatal care and prevention. This scoping review will 32 follow a standard reporting guideline and apply a well-established framework to establish the 33 burden on adverse birth outcomes, identify their pertinent risk factors and explore the 34 evidence for their effects on adverse birth outcomes in the Pacific Islands region. 35 36

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1 2 3 REFERENCES 4 5 1. Weng Y-H, Yang C-Y, Chiu Y-W. Risk Assessment of Adverse Birth Outcomes in Relation to BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Maternal Age. PLoS ONE 2014;9(12):e114843. 7 2. Berhan T, Andargachew K. Prevalence of adverse birth outcome and associated factors among 8 women who delivered in Hawassa town governmental health institutions, south Ethiopia, in 9 2017. Reprod Health 2018;15(1):1-10. 10 3. Sayers SM, Lancaster PAL, Whitehead CL. Fetal Growth Restriction: Causes and Outcomes. In: 11 Quah SR, ed. International Encyclopedia of Public Health (Second Edition). Oxford: 12 Academic Press, 2017:132-42. 13 4. Tesfahun MW, Nigus BY, Asmamaw DB. Risk factors for low birth weight in hospitals of North 14 15 Wello zone, Ethiopia: A case-control study. PLoS ONE 2019;14(3) 16 5. Tampah-Naah AM, Anzagra L, Yendaw E. Factors Correlated with Low Birth Weight in Ghana. 17 British Journal of Medicine & Medical Research 2016;16(4):1-8. [published Online First: 8th 18 June 2016] For peer review only 19 6. Su D, Samson K, Garg A, et al. Birth history as a predictor of adverse birth outcomes: Evidence 20 from state vital statistics data. Preventive Medicine Reports 2018;11:63-68. 21 7. Adane AA, Ayele TA, Ararsa LG, et al. Adverse birth outcomes among deliveries at Gondar 22 University Hospital, Northwest Ethiopia. bmc pregnancy and childbirth 2014;14(1):90-90. 23 8. Tsegaye B, Kassa A. Prevalence of adverse birth outcome and associated factors among women 24 who delivered in Hawassa town governmental health institutions, south Ethiopia, in 2017. 25 Reprod Health 2018;15(1):193-93. 26 9. Chawanpaiboon S, Vogel JP, Moller A-B, et al. Global, regional, and national estimates of levels of 27 preterm birth in 2014: a systematic review and modelling analysis. The Lancet Global Health 28 2019;7(1):e37-e46. 29 10. Charlton KE, Russell J, Gorman E, et al. Fish, food security and health in Pacific Island countries 30 and territories: a systematic literature review. BMC Public Health 2016;16(1):285. 31 11. Dongarwar D, Salihu HM. Place of Residence and Inequities in Adverse Pregnancy and Birth 32 Outcomes in India. Int J MCH AIDS 2020;9(1):53-63. [published Online First: 2019/12/28] 33 12. Horwood PF, Tarantola A, Goarant C, et al. Health Challenges of the Pacific Region: Insights 34 35 From History, Geography, Social Determinants, Genetics, and the Microbiome. Frontiers in 36 Immunology 2019;10(2184)

37 13. OECD, Organization WH. Health at a Glance: Asia/Pacific 2018, 2018. http://bmjopen.bmj.com/ 38 14. Linhart C, Karen Carter, Renee Sorchik, et al. Trends in Neonatal and Infant Mortality for Pacific 39 Island States. Secretariat of the Pacific Community cataloguing-in-publication data, 2015. 40 15. Lee ACC, Katz J, Blencowe H, et al. National and regional estimates of term and preterm babies 41 born small for gestational age in 138 low-income and middle-income countries in 2010. The 42 Lancet Global Health 2013;1(1):e26-e36. 43 16. Yakoob MY, Lawn JE, Darmstadt GL, et al. Stillbirths: Epidemiology, Evidence, and Priorities 44 for Action. Seminars in Perinatology 2010;34(6):387-94. 45 17. WHO. Country Cooperation Strategy at a Glance 2013. on October 1, 2021 by guest. Protected copyright. 46 18. Andrew NL, Bright P, de la Rua L, et al. Coastal proximity of populations in 22 Pacific Island 47 Countries and Territories. PLoS ONE 2019;14(9):e0223249. 48 19. Quinn B, Peach E, Wright CJC, et al. Alcohol and other substance use among a sample of young 49 people in the Solomon Islands Australian and New Zealand Journal of Public Health 50 2017;42( 4):358-64. 51 20. Pratt S. The Challenge of Betel Nut Consumption to Economic Development: a Case of Honiara, 52 Solomon Islands. 2014;21:103. 53 54 21. Jarawan E, Carpio C. Health Challenges in the Small Island Developing Countries of the Pacific 55 and the Caribbean, ( ? ):37. 56 22. De Silva M, Panisi L, Brownfoot FC, et al. Systematic review of areca (betel nut) use and adverse 57 pregnancy outcomes. International Journal of Gynecology & Obstetrics 2019;147(3):292- 58 300. 59 60

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1 2 3 23. Berger KE, Masterson J, Mascardo J, et al. The Effects of Chewing Betel Nut with Tobacco and 4 Pre-pregnancy Obesity on Adverse Birth Outcomes Among Palauan Women. Maternal and 5 Child Health Journal 2016;20(8):1696-703. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 24. Aromataris E, Munn Z. JBI Reviewer's Manual. Joana Briggs Institute: Joana Briggs Institute, 7 2020:488. 8 25. Arksey H, O'Malley L. Scoping studies: towards a methodological framework. International 9 10 Journal of Social Research Methodology 2005;8(1):19-32. 11 26. Peters M, Godfrey C, Khalil H, et al. 2017 Guidance for the Conduct of JBI Scoping Reviews, 12 2017. 13 27. Halas G, Schultz ASH, Rothney J, et al. A scoping review protocol to map the research foci trends 14 in tobacco control over the last decade. BMJ open 2015;5(1):e006643-e43. 15 28. Moher D, Liberati A, Tetzlaff J, et al. Preferred Reporting Items for Systematic Reviews and 16 Meta-Analyses: The PRISMA Statement. PLOS Medicine 2009;6(7):e1000097. 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

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1 2 3 Acknowledgements 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Declaration of interests The authors have no competing interests, no financial relationships 7 with any organisations that might have an interest in the submitted work in the previous three 8 years; no other relationships or activities that could appear to have influenced the submitted 9 work, to declare. 10 11 Ethics and Dissemination Since there will be no direct contact with human or patients in the 12 case of the scoping review, no ethics review will be required. Findings will be presented in 13 14 regional conferences, sent to government departments, and published in peer-reviewed 15 journals. 16 17 Funding The authors declared this research didn't receive grants from any funding agency in 18 the public, commercialFor or not-for-profit peer sectors.review LSKK was only supported by the Australia Award 19 Scholarship which do not provide fundings for pulication. 20 21 22 Author Contributions LSKK wrote the first draft of the paper. All authors contributed to 23 study inception, design, and writing the manuscript revisions and final draft. 24 25 Appendix 26 27 Table 1. Grid of key concepts and terms 28 29 30 Concept 1 Concept 2 Concept 3 31 32 Adverse birth outcomes AND Pregnancy Risk factors AND Pacific Island region 33 34 35 Table 2. Data extraction table 36 37 Main category http://bmjopen.bmj.com/ 38 a) Author(s) 39 40 b) Year of publication 41 c) Origin/country study was conducted 42 d) Aims/purpose 43 e) Study population 44

45 f) Sample size on October 1, 2021 by guest. Protected copyright. 46 g) Methodology 47 h) Intervention/exposure type (if applicable) and comparison group (if applicable) 48 i) Duration of the exposure/intervention (if applicable) 49 j) Outcomes assessment and method to assess associations (if applicable) 50 51 k) Key findings that relate to the scoping review question/s 52 53 54 55 56 57 58 59 60

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Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2020-042423.R1 review only Article Type: Protocol

Date Submitted by the 08-Jan-2021 Author:

Complete List of Authors: Kaforau, Lydia; NRH , Department of Paediatrics and Neonatal Care, National Referral Hospital; Curtin University, School of Public Health Tessema, Gizachew; Curtin University Bentley Campus, School of Public Health ; University of Adelaide, School of Public Health Jancey, Jonine; Curtin University, School of Public Health Dhamrait, Gursimran; Telethon Kids Institute; The University of Western Australia Faculty of Health and Medical Sciences, School of Population and Global Health Bugoro, Hugo ; Solomon Islands National University, Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University Pereira, G.F; Curtin University, School of Public Health ; Centre for Fertility and Health (CeFH), Norwegian Institute of Public Health

Primary Subject http://bmjopen.bmj.com/ Public health Heading:

Secondary Subject Heading: Epidemiology, Reproductive medicine

Keywords: PERINATOLOGY, EPIDEMIOLOGY, PUBLIC HEALTH

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1 2 3 Manuscript 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping 7 review protocol. 8 9 Lydia Sandrah Kuman Kaforau,1,2 Gizachew Assefa Tessema,2,3 Jonine Jancey,2 Gursimran 10 Kaur Dhamrait,4,5 Hugo Bugoro,6 G.F Pereira,2,4,7 11 12 1Department of Paediatrics and Neonatal Care, National Referral Hospital, Solomon Islands 13 2 14 School of Public Health, Curtin University, Western Australia, Perth, Australia. 15 3School of Public Health, the University of Adelaide, South Australia, Adelaide, Australia. 16 4Telethon Kids Institute, Nedlands, Western Australia, Perth, Australia. 17 5School of Population and Global Health, Faculty of Health and Medical Sciences, The 18 University of WesternFor Australia, peer Nedlands, review Western Australia, only Australia. 19 6Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University. 20 7 21 Centre for Fertility and Health (CeFH), Norwegian Institute of Public Health, Oslo, Norway. 22 23 Address correspondence to: 24 Lydia S.K. Kaforau 25 School of Public Health, Curtin University, 26 400 Kent St, Bentley Western Australia, 6102 27 Email: [email protected] 28 29 Phone: +61 433 956 543 30 31 Main Body Word Count: 2279 32 33 Abstract Word Count: 258 34 35 Short Title: Risk factors of adverse birth outcomes 36

45 UNICEF-united nation international children emergency fund on October 1, 2021 by guest. Protected copyright. 46 WHO-world health organisation 47 48 Keywords: 49 Adverse Birth Outcomes 50 Low Birth Weight 51 52 Preterm Birth 53 Risk Factors 54 Pacific Island region 55 56 57 58 59 60

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1 2 3 ABSTRACT 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Introduction 7 Fetal growth restriction, preterm birth and stillbirth are adverse birth outcomes that are 8 prevalent in low-and middle-income settings such as the Pacific Island region. It is widely 9 accepted that the excess burden of adverse birth outcomes is attributable to socio-economic 10 and environmental factors that predispose families to excess risk. Our review seeks to 11 determine the prevalence of adverse birth outcomes in the Pacific Island region; and to 12 identify the risk factors of adverse birth outcomes in the Pacific Island region. 13 14 15 Methods 16 This scoping review will follow the five-staged Arksey and O’Malley’s framework and 17 consultation with Solomon Islands’ health stakeholders. A preliminary literature review was 18 undertaken to understandFor the peer scope of the review review. We will onlyuse MeSH (medical subject 19 heading) and keyword terms for adverse birth outcomes to search CINAHL, Medline, 20 st 21 Scopus, ProQuest, and Springer Link databases for articles published from 1 January 2000. 22 The subsequent searches will be undertaken via google scholar and the internet browser to 23 world health organisations and regional health organisation for published and unpublished 24 reports on non-indexed studies. All articles retrieved will be managed with software such as 25 Endnote. Eligible studies will be screened using PRISMA flow chart for final selection. The 26 results will be presented as numerical and thematic summaries that map risk factors and 27 prevalence to the population and cultures of the Pacific Island region. 28 29 30 Ethics and Dissemination 31 Formal ethical approval is not required as primary or administrative data will not be 32 collected. The findings of this study will be published in peer-reviewed journals and 33 presented in national and regional conferences. 34 35 36

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Strengths and limitations of this study BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6  The review will provide information to help identify knowledge gaps and focal points for 7 further investigation to progress towards this goal. 8  A strength of this study will be consultation with stakeholders (health professionals 9 working in maternal and child health services) as they will provide insights into adverse 10 birth outcomes at a community level. 11 12  We may not be able to access studies published in languages other than English. 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

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1 2 3 INTRODUCTION 4 5 Despite improvements in medical care and technology, the incidence of adverse birth BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 outcomes remains a significant public health issue, particularly in low and middle-income 7 countries (LMICs).1 2 Adverse birth outcomes include indicators for early gestation (preterm 8 birth), fetal growth restriction and perinatal mortality. Preterm birth is the most well-accepted 9 10 benchmark for morbidity attributable to early gestation and is defined as birth before 37 2 11 weeks of completed gestation. In LMICs, fetal growth restriction is indicated by its proxies 12 ascertained at birth.3 These proxies include term low birth weight (LBW); defined as birth 13 weight <2,500 grams from 37 weeks of completed gestation, and small for gestational age 14 (SGA); defined as weight in the lowest 10th centile for gestational age and sex or as a 15 multiple of standard deviations from the sex-specific population mean weight. LBW is also 16 historically used as a proxy for preterm birth given the lack of information on gestational 17 4 5 1 2 18 length. Fetal growthFor restriction peer is associated review with infant mortalityonly and morbidity. 19 Stillbirth is the most commonly investigated mortality-related outcome and is defined as birth 20 without signs of life from 28 weeks of completed gestation in LMIC.1 Both preterm birth and 21 fetal growth restriction can significantly impact longer-term physiological complications and 22 wellbeing of children6 7 and are major risk factors for stillbirth. 23 24 The aetiologies of adverse birth outcomes are multifactorial and not entirely well 25 understood.1 Evidence from studies conducted elsewhere show that socioeconomic, health, 26 obstetric and biological factors are linked with adverse birth outcomes in high income 27 countries as well as LMICs.2 6 8-10 Moreover, evidence has also shown that environmental 28 (non-genetic) risk factors are relatively more prevalent in LMICs resulting in higher infant 29 6 7 30 mortality and morbidity in these countries. More than 96% of the 32 million LBW infants 8 31 born globally each year occur in LMICs. Although adverse birth outcomes are reasonably 32 well documented in some LMICs, such as India,11 studies in the Pacific Island region remain 33 sparse. 34 35 The Pacific Island region broadly refers to a group of countries and territories that border the 36 Pacific Ocean.12 The region, defined here as the LMICs and territories within the Melanesian, 37 Polynesian and Micronesian sub-regions, are culturally and ethnically diverse, with varying http://bmjopen.bmj.com/ 38 degrees of economic development and living standards.12 The indigenous populations of the 39 region are typically overrepresented in national and global scales for disease burden for both 40 communicable and non-communicable diseases.12 Health indicators also vary considerably 41 42 across this region; for example, the infant mortality rate in Papua New Guinea is 50 per 1,000 13 43 births compared to 20 per 1,000 births in Fiji. Similarly, LBW and SGA also vary within 44 and between countries of the region with reported prevalence inconsistent and under- 45 reported.14 A review in 2013 estimated a period prevalence of 8% for preterm birth, 10% for on October 1, 2021 by guest. Protected copyright. 46 LBW and 19% for SGA in the broader region of Oceania,15 but these prevalence are not well- 47 established for the Pacific Island region specifically. Moreover, although it is estimated that 48 98% of stillbirths occur in LMICs,16 there are no high-quality estimates for stillbirth 49 50 prevalence in the Pacific Island region. In the last two decades, there has been a substantial 51 decline in infant and child mortality by approximately 50% in more than half of the Pacific 52 Island countries and territories.14 However, the extent of such improvements remains 53 uncertain due to poor data quality and coverage and impacting cultural factors. 54 55 Deficiency in the provision of basic health services such as antenatal care and delivery 56 services, infrastructure, telecommunication and transportation are pertinent contributors to 57 the burden of adverse birth outcomes in the Pacific Island region.17 Notably, more than 60% 58 of the population in the region live in rural areas.18 Factors such as access to health care, diet 59 and substance use vary considerably. There is some indication that levels of alcohol 60

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1 2 3 consumption, and tobacco, and substance use (including Betel or Areca nut) may be among 4 19-23

the highest globally. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 The aim of this scoping review is to synthesise available results from studies on the 7 prevalence and risk factors of adverse birth outcomes in the Pacific Island region. Knowledge 8 of the burden of adverse birth outcomes and key risk factors will provide policy makers and 9 10 healthcare practitioners working in the region with evidence that can be used to inform 11 strategies to achieve reductions in adverse birth outcomes and improve overall perinatal 12 health. These research findings will help to design targeted interventions and better allocate 13 resources to where they are needed. Additionally, findings of the review will inform future 14 aetiological research on the effect of risk factors of adverse birth outcomes in the region. 15 16 17 METHODS 18 For peer review only 24 19 This scoping review will follow the Joanna Briggs Institute Reviewers Manual derived from 25 20 Arksey and O’Malley’s five-staged methodological Framework and further developed by 21 Levac, et al. 26 Briefly, this includes explicit specification of research questions, reproducible 22 methods to identify relevant studies, transparent declarations of inclusion and exclusion 23 criteria, documented collation of data, and standardised summarisation and reporting of 24 results. We will also include an optional stage six of stakeholder consultation for additional 25 insights. Our reporting will also compliant with Preferred Reporting Items for Systematic 26 24 27 Reviews and Meta-Analyses extension for scoping reviews checklist. A preliminary 28 literature review was undertaken to understand the extent of literature on exposures of risk 29 factors of adverse birth outcomes in the Pacific Island region, to determine an appropriate 30 search timeframe. Thus, the scoping review will be conducted between December 2020 and 31 February 2021. 32 33 Stage one: Specification of the research question. 34 We will first identify the research question. A preliminary literature review was undertaken to 35 understand the extent of literature on exposures of risk factors of adverse birth outcomes in 36 the Pacific Island region, to determine an appropriate search timeframe. This stage will allow http://bmjopen.bmj.com/ 37 the formulation of the research questions for the study. The broad research questions are: 38 39 What is the prevalence of the adverse birth outcomes in the Pacific Island region? What are 40 the risk factors of adverse birth outcomes in the Pacific Island region? The indigenous 41 population of the region are broadly classified as Melanesian, Polynesian and Micronesians, 42 each with their own diverse historical roots and cultures.12 Such diversity is accompanied by 43 differences in economic development and living standards, causing a wide variation in health 44 outcomes between populations.12 Consequently, this review will also describe the prevalence 45 on October 1, 2021 by guest. Protected copyright. 46 and risk factors by sub-population group. 47 48 Stage two: Identifying relevant studies 49 The second stage of the review aims to identify the relevant studies through the eligibility 50 criteria, and search strategies involved. The Arksey and O’Malley’s methodological 51 framework25 uses Population-Concept-Context. For this review, the Population is defined as 52 all women of child-bearing age (15-49 years old) who gave birth in the Pacific Island region 53 54 and infants from these births; Concept is the prevalence and risk factors for adverse birth 55 outcomes (low birthweight, preterm birth, small for gestational age or fetal growth restriction, 56 stillbirths and miscarriage); and Context is defined geographically as all 21 countries and 57 territories in the region. 58 59 Inclusion and exclusion criteria 60

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1 2 3 We will include all studies and articles irrespective of their study design. We will incorporate 4

all studies that report risk factors and their associations with one or more of the adverse birth BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 outcomes in the Pacific Island region arising during pregnancy but observed at the separation 7 of the fetus from the mother or shortly afterwards. We will include studies that will provide 8 estimates of the prevalence rates and risk factors of adverse birth outcomes. That include 9 inferential studies that aimed to estimate the prevalence and identify associated risk factors 10 such as intervention and observational studies. Our review will also include descriptive 11 population-based studies such as the Demographic Health Surveys and other surveys. We 12 will include studies from the 21 sovereign island states and territories of the region namely: 13 14 American Samoa, Cook Islands, Easter Islands, Federated States of Micronesia, Fiji, Guam, 15 Kiribati, Mariana Islands, Marshall Islands, Nauru, New Caledonia, Niue, Palau, Papua New 16 Guinea, Samoa, Solomon Islands, Tahiti, Tokelau, Tonga, Tuvalu, Vanuatu and Wallis and 17 Futuna.14 Both primary and secondary analytical studies published in peer-reviewed journals 18 and grey literature asFor government peer reports review will be included. onlyStudies published in English from 19 the year 2000 to February 2021 will be included. 20 21 Search Strategy 22 The search strategy will follow the three-stage search process outlined by the Joanna Briggs 23 Institute.27 The first stage will include an initial search that will be made in CINAHL and 24 Medline to identify MeSH or text terms contained within the titles and abstracts of articles 25 26 from the keywords displayed (see table 1). In the second stage of the search, all MeSH terms 27 and/or synonyms will then be applied across the selected databases and combined with 28 Boolean operators, truncations, and wildcards. The following electronic databases will be 29 searched: CINAHL, Medline, ProQuest, SpringerLink and Scopus. In this stage, we will 30 carry out two levels of searches. The first level will use general key MeSH terms and their 31 synonyms of pregnancy risk factors such as adverse birth outcomes and Pacific Island region. 32 33 The general search string will be defined as; (adverse pregnancy outcomes OR poor 34 pregnancy outcomes OR adverse birth outcomes OR poor birth outcomes OR preterm birth 35 OR fetal growth restriction OR low birth weight OR stillbirth) AND (pregnancy risk factors 36 OR pregnancy risk*) AND (Pacific Island* OR Oceania OR South Pacific Island*). 37 Similarly, a specific search with more precise key terms or specific risk factors will narrow http://bmjopen.bmj.com/ 38 the search down for each country. Specific search terms will be identified through the initial 39 literature review to understand the specific risk factors within the population. The specific 40 41 key terms for risk factors will be defined as; malaria OR anaemia OR substance use OR 42 alcohol OR betel nut OR areca nut OR tobacco OR maternal obesity OR maternal nutrition. 43 The above specific terms will be combined with a term to identify each individual country 44 within the region. We will also assess the reference list of studies initially retrieved in order 45 to identify any relevant studies which have not been identified by the electronic database on October 1, 2021 by guest. Protected copyright. 46 searches. Additional searches will also be conducted to identify non-indexed studies and 47 manually searching thesis repositories, Google Scholar and Google for regional health 48 49 organisation websites. The online sources that we will search include the United Nations 50 International Children Emergency Fund, World Health Organisation, Pacific community and 51 individual countries health websites. 52 53 Stage three: Study selection 54 At this stage, we will screen and select the studies. During the primary review, we will 55 56 consolidate all studies retrieved, remove all duplicates and remove studies that do not 28 57 correspond to the Population Concept Context criteria. Next, we will screen the titles and 58 abstracts of articles after importing all records retrieved from databases and web-based 59 searches into EndNote. Two reviewers (LK and GT ) will be conducting the study selection 60 and data abstraction.26 Any uncertainty with the title and abstract will go through full-text

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1 2 3 review. Any uncertainty reached on any article will be discussed with the broader research 4

team. If consensus is not reached, articles will be excluded from the review. All remaining BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 29 6 articles will go through full-text screening, following the PRISMA flow chart and final 7 articles will proceed to the final review. 8 9 Stage four: Charting data 10 Data charting will involve data extraction and documenting from the final articles selected. 11 During the data extraction, all results will be entered into Excel spreadsheets alongside 12 standard bibliographic information that includes author(s), year of publication, origin or 13 14 country of origin, aims and purpose, study population, methodology, intervention type, 15 intervention duration, outcomes and details and key findings (see table 2 outlines the standard 16 bibliographic information).27 For each article, reviewed key information to be retrieved will 17 be risk factors matched to birth outcomes, prevalence to the specific context of the region. 18 The framework willFor be pilot peertested by the review reviewers to ensure only that it is consistent with data 19 charting and the study aims and objectives. Charting of data will be an iterative process of 20 21 screening and extracting data that will be done mostly by the principal investigator. Any 22 arising questions and uncertainty during the process will be discussed research team to reach 23 an agreement. 24 25 Stage five: Collating, summarising, and presenting the results 26 In stage five, tabular presentation of the findings will be mapped from data extracted from the 27 selected articles, as outlined, (see table 2) and guided by Arskey and O’Malley.25 Findings 28 29 will be presented quantitatively in aggregated forms figure and qualitatively as thematic 25 30 narrative summaries, all of which will reflect the study objectives. The results of the studies 31 will not be compared but presented as a body of evidence. We expect to map a wide range of 32 risk factors, prevalence, and the different adverse birth outcomes against the countries’ 33 ethnic, and geographical diversity to provide the first such body of literature for the region. 34 35 Stage six: Stakeholder consultation 36

37 A consultation exercise will be conducted online with relevant health professionals in the http://bmjopen.bmj.com/ 38 Solomon Islands, including midwives, paediatric nurses, obstetricians, and paediatricians 39 identified through contacts and purposive and snowball sampling. This stage aims to validate 40 findings from this study and to add additional insights and recommendations from their 41 perspectives. Consultation will be undertaken at the completion of the article review. The 42 exercise will involve the collection of quantitative and qualitative feedback from clinicians 43 44 who work with pregnant mothers and infants to obtain their knowledge and experience of risk

45 factors and birth outcomes in the Solomon Islands from a clinical perspective. Ten health on October 1, 2021 by guest. Protected copyright. 46 professionals working with pregnant woman and infants will be consulted. Selection will be 47 made by purposeful and snowball sampling. 48 49 Stage seven: Patient and public involvement. 50 51 The scoping review will not involve patients and the public as data will be sourced from 52 primary studies. The stakeholder consultation exercise will only be involving doctors, 53 midwives and nurses who work directly with pregnant women. Ethics and consent will be 54 sought to respective authorities and clinicians. 55 56 57 58 59 60

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1 2 3 Acknowledgements 4 5 The authors acknowledge the invaluable support and input from the librarian (Faculty of BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Health Science of Curtin University), the reviewers (BMJ open) and our team of peer 7 reviewers. 8 9 10 Contributorship Statement 11 All authors contributed to the preparation of the manuscript as listed below. 12 LSKK, GFP, GAT and JJ: study inception, conceptualisation and design, LSKK: first draft, 13 literature review, preliminary searches, collating all inputs reiteratively and revision of the 14 manuscript, GKD: first edited and framed the manuscript into standard journal format, and 15 GAT, JJ, HB and GFP: subsequent revisions, editing and proof reading. 16 17 Co-Authors’ Email Addresses 18 For peer review only 19 Gizachew A. Tessema [email protected] 20 Jonine Jancey [email protected] 21 Gursimran K. Dhamrait [email protected] 22 Hugo Bugoro [email protected] 23 Gavin Pereira [email protected] 24 25 26 Competing interests 27 None declared. 28 29 Funding 30 Article Processing Charge (APC) waiver claim 00164914. Full waiver grant number 00D0YaQIK. 31 _5001v1P90VA. 32 Department of Health, Australian Government, National Health and Medical Research 33 Grants. #1099655 to GP, #1173991 to GP, #1195716 to GAT. 34 Research Council of Norway Grants #262700 to GP 35 36

37 Ethics and Dissemination http://bmjopen.bmj.com/ 38 Since there will be no direct contact with human or patients in the case of the scoping review, 39 no ethics review will be required. Dissemination will be made through regional conferences 40 and publication in peer-reviewed journals. 41 42 43 44

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1 2 3 4 5 Reference BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 7 1. Weng Y-H, Yang C-Y, Chiu Y-W. Risk Assessment of Adverse Birth Outcomes in Relation to 8 Maternal Age. PLOS ONE 2014;9(12):e114843. doi: 10.1371/journal.pone.0114843 9 2. Berhan T, Andargachew K. Prevalence of adverse birth outcome and associated factors among 10 women who delivered in Hawassa town governmental health institutions, south Ethiopia, in 11 2017. Reprod Health 2018;15(1):1-10. 12 3. Sayers SM, Lancaster PAL, Whitehead CL. Fetal Growth Restriction: Causes and Outcomes. In: 13 14 Quah SR, ed. International Encyclopedia of Public Health (Second Edition). Oxford: Academic 15 Press, 2017:132-42. 16 4. Tesfahun MW, Nigus BY, Asmamaw DB. Risk factors for low birth weight in hospitals of North 17 Wello zone, Ethiopia: A case-control study. PLoS One 2019;14(3) doi: 18 org/10.1371/journal.pone.0213054For peer review only 19 5. Tampah-Naah AM, Anzagra L, Yendaw E. Factors Correlated with Low Birth Weight in Ghana. 20 British Journal of Medicine & Medical Research 2016;16(4):1-8. doi: 21 10.9734/BJMMR/2016/24881 [published Online First: 8th June 2016] 22 23 6. Su D, Samson K, Garg A, et al. Birth history as a predictor of adverse birth outcomes: Evidence 24 from state vital statistics data. Preventive Medicine Reports 2018;11:63-68. 25 7. Adane AA, Ayele TA, Ararsa LG, et al. Adverse birth outcomes among deliveries at Gondar 26 University Hospital, Northwest Ethiopia. bmc pregnancy and childbirth 2014;14(1):90-90. 27 8. Tsegaye B, Kassa A. Prevalence of adverse birth outcome and associated factors among women 28 who delivered in Hawassa town governmental health institutions, south Ethiopia, in 2017. 29 Reprod Health 2018;15(1):193-93. doi: 10.1186/s12978-018-0631-3 30 9. Chawanpaiboon S, Vogel JP, Moller A-B, et al. Global, regional, and national estimates of levels of 31 32 preterm birth in 2014: a systematic review and modelling analysis. The Lancet Global Health 33 2019;7(1):e37-e46. 34 10. Charlton KE, Russell J, Gorman E, et al. Fish, food security and health in Pacific Island countries 35 and territories: a systematic literature review. BMC Public Health 2016;16(1):285. 36 11. Dongarwar D, Salihu HM. Place of Residence and Inequities in Adverse Pregnancy and Birth 37 Outcomes in India. Int J MCH AIDS 2020;9(1):53-63. [published Online First: 2019/12/28] http://bmjopen.bmj.com/ 38 12. Horwood PF, Tarantola A, Goarant C, et al. Health Challenges of the Pacific Region: Insights From 39 History, Geography, Social Determinants, Genetics, and the Microbiome. Frontiers in 40 Immunology 2019;10(2184) 41 42 13. OECD, Organisation WH. Health at a Glance: Asia/Pacific 2018, 2018. 43 14. Linhart C, Karen Carter, Renee Sorchik, et al. Trends in Neonatal and Infant Mortality for Pacific 44 Island States. Secretariat of the Pacific Community cataloguing-in-publication data, 2015.

45 15. Lee ACC, Katz J, Blencowe H, et al. National and regional estimates of term and preterm babies on October 1, 2021 by guest. Protected copyright. 46 born small for gestational age in 138 low-income and middle-income countries in 2010. The 47 Lancet Global Health 2013;1(1):e26-e36. 48 16. Yakoob MY, Lawn JE, Darmstadt GL, et al. Stillbirths: Epidemiology, Evidence, and Priorities for 49 Action. Seminars in Perinatology 2010;34(6):387-94. 50 51 17. WHO. Country Cooperation Strategy at a Glance 2013. 52 18. Andrew NL, Bright P, de la Rua L, et al. Coastal proximity of populations in 22 Pacific Island 53 Countries and Territories. PLOS ONE 2019;14(9):e0223249. 54 19. Quinn B, Peach E, Wright CJC, et al. Alcohol and other substance use among a sample of young 55 people in the Solomon Islands Australian and New Zealand Journal of Public Health 2017;42( 56 4):358-64. 57 20. Pratt S. The Challenge of Betel Nut Consumption to Economic Development: a Case of Honiara, 58 Solomon Islands. 2014;21:103. 59 60

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1 2 3 21. Jarawan E, Carpio C. Health Challenges in the Small Island Developing Countries of the Pacific and 4 the Caribbean, ( ? ):37. 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 22. De Silva M, Panisi L, Brownfoot FC, et al. Systematic review of areca (betel nut) use and adverse 7 pregnancy outcomes. International Journal of Gynecology & Obstetrics 2019;147(3):292-300. 8 23. Berger KE, Masterson J, Mascardo J, et al. The Effects of Chewing Betel Nut with Tobacco and 9 Pre-pregnancy Obesity on Adverse Birth Outcomes Among Palauan Women. Maternal and 10 Child Health Journal 2016;20(8):1696-703. 11 24. Aromataris E, Munn Z. JBI Reviewer's Manual. Joana Briggs Institute: Joana Briggs Institute, 12 2020:488. 13 25. Arksey H, O'Malley L. Scoping studies: towards a methodological framework. International 14 Journal of Social Research Methodology 2005;8(1):19-32. 15 16 26. Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implementation 17 Science 2010;5(1):69. doi: 10.1186/1748-5908-5-69 18 27. Peters M, GodfreyFor C, Khalil peerH, et al. 2017 review Guidance for the Conductonly of JBI Scoping Reviews, 2017. 19 28. Halas G, Schultz ASH, Rothney J, et al. A scoping review protocol to map the research foci trends 20 in tobacco control over the last decade. BMJ Open 2015;5(1):e006643-e43. 21 29. Moher D, Liberati A, Tetzlaff J, et al. Preferred Reporting Items for Systematic Reviews and Meta- 22 Analyses: The PRISMA Statement. PLOS Medicine 2009;6(7):e1000097. 23 24 25 26 27 Table 1. Grid of key concepts and terms 28 Concept 1 Concept 2 Concept 3 29 30 31 Adverse birth AND Pregnancy Risk AND Pacific Island 32 outcomes factors region 33 34 Table 2. Data extraction table 35 36 Main category

37 a) Author(s) http://bmjopen.bmj.com/ 38 b) Year of publication 39 c) Origin/country study was conducted 40 d) Study design: 41 42 e) Aims/purpose 43 f) Sampling strategy 44 g) Study population 45 h) Sample size on October 1, 2021 by guest. Protected copyright. 46 47 i) Methodology 48 j) Intervention/exposure type (if applicable) and comparison group (if applicable) 49 k) Duration of the exposure/intervention (if applicable) 50 l) Outcomes assessment and method to assess associations (if applicable) 51 m) Key findings that relate to the scoping review question/s 52 53 54 55 56 57 58 59 60

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Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Journal: BMJ Open ManuscriptFor ID peerbmjopen-2020-042423.R2 review only Article Type: Protocol

Date Submitted by the 16-Mar-2021 Author:

Complete List of Authors: Kaforau, Lydia; Solomon Islands National University, Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University; Curtin University Faculty of Health Sciences, School of Public Health Tessema, Gizachew; Curtin University Faculty of Health Sciences, School of Public Health ; The University of Adelaide Faculty of Health Sciences, School of Public Health, University of Adelaide Jancey, Jonine; Curtin University Faculty of Health Sciences, School of Public Health Dhamrait, Gursimran; Telethon Kids Institute, Public Health ; The University of Western Australia Faculty of Health and Medical Sciences, School of Population and Global Health Bugoro, Hugo ; Solomon Islands National University, Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University

Pereira, G.F; Curtin University Faculty of Health Sciences, School of http://bmjopen.bmj.com/ Public Health ; Norwegian Institute of Public Health, Norwegian Institute of Public Health, Centre for Fertility and Health (CeFH)

Primary Subject Public health Heading:

Secondary Subject Heading: Epidemiology, Reproductive medicine

Keywords: PERINATOLOGY, EPIDEMIOLOGY, PUBLIC HEALTH on October 1, 2021 by guest. Protected copyright.

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1 2 3 Manuscript 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping 7 review protocol. 8 9 Lydia Sandrah Kuman Kaforau,1,2 Gizachew Assefa Tessema,2,3 Jonine Jancey,2 Gursimran 10 Kaur Dhamrait,4,5 Hugo Bugoro,1 G.F Pereira,2,4,6 11 12 1Faculty of Nursing, Medicine and Health Sciences, Solomon Islands National University. 13 2 14 School of Public Health, Curtin University, Perth, Western Australia, Australia. 15 3School of Public Health, The University of Adelaide, Adelaide South Australia, Australia. 16 4Telethon Kids Institute, Nedlands, Perth, Western Australia, Australia. 17 5School of Population and Global Health, Faculty of Health and Medical Sciences, The 18 University of WesternFor Australia, peer Nedlands, review Western Australia, only Australia. 19 6Centre for Fertility and Health (CeFH), Norwegian Institute of Public Health, Oslo, Norway. 20 21 22 Address correspondence to: 23 Lydia S.K. Kaforau 24 School of Public Health, Curtin University, 25 400 Kent St, Bentley Western Australia, 6102 26 Email: [email protected] 27 Phone: +61 433 956 543 28 29 30 Main Body Word Count: 2594 31 32 Abstract Word Count: 296 33 34 Short Title: Risk factors of adverse birth outcomes 35 36

37 Abbreviations: http://bmjopen.bmj.com/ 38 CINAHL-cumulative index to nursing and allied health 39 LBW- low birth weight 40 LMICs - low- and middle-income countries 41 PRISMA- preferred reporting items for systematic reviews and meta-analyses 42 SGA- small for gestational age 43 44 UNICEF-united nation international children emergency fund

45 WHO-world health organisation on October 1, 2021 by guest. Protected copyright. 46 47 Keywords: 48 Adverse birth outcomes 49 Low birth weight 50 Preterm birth 51 52 Risk factors 53 Pacific Island region 54 55 56 57 58 59 60

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1 2 3 ABSTRACT 4 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Introduction 7 Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth 8 outcomes that are prevalent in low-and middle-income settings such as the Pacific Island 9 region. It is widely accepted that the excess burden of adverse birth outcomes is attributable 10 to socio-economic and environmental factors that predispose families to excess risk. Our 11 review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island 12 region; and to identify the risk factors of adverse birth outcomes in the Pacific Island region. 13 14 15 Methods 16 This scoping review will follow the five-staged Arksey and O’Malley’s framework and 17 consultation with Solomon Islands’ health stakeholders. A preliminary literature review was 18 undertaken to understandFor the peer scope of the review review. We will onlyuse MeSH (medical subject 19 heading) and keyword terms for adverse birth outcomes to search CINAHL, Medline, 20 st 21 Scopus, ProQuest, and Springer Link databases for articles published from 1 January 2000. 22 The subsequent searches will be undertaken via google scholar and the internet browser to 23 world health organisations and regional health organisation for published and unpublished 24 reports on non-indexed studies. All articles retrieved will be managed with Endnote software. 25 Eligible studies will be screened using PRISMA flow chart for final selection. In the charting 26 phase, we will extract the data into excel spreadsheets. The results will be presented as 27 numerical and thematic summaries that map risk factors and prevalence to the population and 28 29 cultures of the Pacific Island region. 30 31 Ethics and Dissemination 32 Formal ethical approval is not required as primary or administrative data will not be 33 collected. However, we will seek ethics approval for the stakeholder consultation from the 34 Research Office of Curtin University and the Solomon Islands. The findings of this study will 35 be published in peer-reviewed journals, and presented in national and regional conferences 36

37 and disseminated to stakeholders. http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

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1 2 3 4

Strengths and limitations of this study BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6  The review will provide information to help identify knowledge gaps and focal points for 7 further investigation to progress towards evidenced based maternal health care in the 8 region. 9  A strength of this study will be consultation with stakeholders (health professionals 10 working in maternal and child health services) as they will provide insights into adverse 11 birth outcomes at a community level. 12 13  We may not be able to access studies published in languages other than English. 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36

37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 2 3 INTRODUCTION 4 5 Despite improvements in medical care and technology, the incidence of adverse birth BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 outcomes remains a significant public health issue, particularly in low and middle-income 7 1 2 8 countries (LMICs). Adverse birth outcomes include indicators for early gestation (preterm 9 birth), fetal growth restriction and perinatal mortality. Preterm birth is the most well-accepted 10 benchmark for morbidity attributable to early gestation and is defined as birth before 37 11 weeks of completed gestation.2 In LMICs, fetal growth restriction is indicated by its proxies 12 ascertained at birth.3 These proxies include term low birth weight (LBW); defined as birth 13 weight <2,500 grams from 37 weeks of completed gestation, and small for gestational age 14 (SGA); defined as weight in the lowest 10th centile for gestational age and sex or as a 15 16 multiple of standard deviations from the sex-specific population mean weight. LBW is also 17 historically used as a proxy for preterm birth given the lack of information on gestational 18 length.4 5 Fetal growthFor restriction peer is associated review with infant mortalityonly and morbidity.1 2 19 Stillbirth is the most commonly investigated mortality-related outcome and is defined as birth 20 without signs of life from 28 weeks of completed gestation in LMIC.1 Both preterm birth and 21 fetal growth restriction can significantly impact longer-term physiological complications and 22 wellbeing of children6 7 and are major risk factors for stillbirth. 23 24 The aetiologies of adverse birth outcomes are multifactorial and not entirely well 25 understood.1 Evidence from studies conducted elsewhere show that socioeconomic, health, 26 obstetric and biological factors are linked with adverse birth outcomes in high income 27 2 6 8-10 28 countries as well as LMICs. Moreover, evidence has also shown that environmental 29 (non-genetic) risk factors are relatively more prevalent in LMICs resulting in higher infant 30 mortality and morbidity in these countries.6 7 More than 96% of the 32 million LBW infants 31 born globally each year occur in LMICs.8 Although adverse birth outcomes are reasonably 32 well documented in some LMICs, such as India,11 studies in the Pacific Island region remain 33 sparse. 34 35 The Pacific Island region broadly refers to a group of countries and territories that border the 36 Pacific Ocean.12 The region, defined here as the LMICs and territories within the Melanesian, 37 Polynesian and Micronesian sub-regions, are culturally and ethnically diverse, with varying http://bmjopen.bmj.com/ 38 degrees of economic development and living standards.12 The indigenous populations of the 39 40 region are typically overrepresented in national and global scales for disease burden for both 12 41 communicable and non-communicable diseases. Health indicators also vary considerably 42 across this region; for example, the infant mortality rate in Papua New Guinea is 50 per 1,000 43 births compared to 20 per 1,000 births in Fiji.13 Similarly, LBW and SGA also vary within 44 and between countries of the region with reported prevalence inconsistent and under- 45 reported.14 A review in 2013 estimated a period prevalence of 8% for preterm birth, 10% for on October 1, 2021 by guest. Protected copyright. 46 LBW and 19% for SGA in the broader region of Oceania,15 but these prevalence are not well- 47 48 established for the Pacific Island region specifically. Moreover, although it is estimated that 16 49 98% of stillbirths occur in LMICs, there are no high-quality estimates for stillbirth 50 prevalence in the Pacific Island region. In the last two decades, there has been a substantial 51 decline in infant and child mortality by approximately 50% in more than half of the Pacific 52 Island countries and territories.14 However, the extent of such improvements remains 53 uncertain due to poor data quality and coverage and impacting cultural factors. 54 55 Deficiency in the provision of basic health services such as antenatal care and delivery 56 services, infrastructure, telecommunication and transportation are pertinent contributors to 57 the burden of adverse birth outcomes in the Pacific Island region.17 Notably, more than 60% 58 of the population in the region live in rural areas.18 Factors such as access to health care, diet 59 60 and substance use vary considerably. There is some indication that levels of alcohol

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1 2 3 consumption, and tobacco, and substance use (including betel or areca nut) may be among the 4 19-23

highest globally. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 The aim of this scoping review is to synthesise available results from studies on the 7 prevalence and risk factors of adverse birth outcomes in the Pacific Island region. Knowledge 8 of the burden of adverse birth outcomes and key risk factors will provide policy makers and 9 10 healthcare practitioners working in the region with evidence that can be used to inform 11 strategies to achieve reductions in adverse birth outcomes and improve overall perinatal 12 health. These research findings will help to design targeted interventions and better allocate 13 resources to where they are needed. Additionally, findings of the review will inform future 14 aetiological research on the effect of risk factors of adverse birth outcomes in the region. 15 16 17 METHODS 18 For peer review only 24 19 This scoping review will follow the Joanna Briggs Institute Reviewers Manual derived from 25 20 Arksey and O’Malley’s five-staged methodological Framework and further developed by 21 Levac, et al. 26 Briefly, this includes explicit specification of research questions, reproducible 22 methods to identify relevant studies, transparent declarations of inclusion and exclusion 23 criteria, documented collation of data, and standardised summarisation and reporting of 24 results. The scoping review will not involve patients and the public as data will be sourced 25 from primary studies. However, we will also include an optional stage six of stakeholder 26 27 consultation for additional insights. The stakeholder consultation exercise will only be 28 involving doctors, midwives and nurses who work directly with pregnant women. Ethics and 29 consent will be sought from respective authorities and clinicians. Our reporting will also 30 compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 31 extension for scoping reviews checklist.24 A preliminary literature review was undertaken to 32 understand the extent of literature on exposures of risk factors of adverse birth outcomes in 33 34 the Pacific Island region, to determine an appropriate search timeframe. Thus, the scoping 35 review will be conducted between December 2020 and February 2021. 36 37 Stage one: Specification of the research question. http://bmjopen.bmj.com/ 38 We will first identify the research question. A preliminary literature review was undertaken to 39 understand the extent of literature on exposures of risk factors of adverse birth outcomes in 40 the Pacific Island region, to determine an appropriate search timeframe. This stage will allow 41 42 the formulation of the research questions for the study. The broad research questions are: 43 What is the prevalence of the adverse birth outcomes in the Pacific Island region? What are 44 the risk factors of adverse birth outcomes in the Pacific Island region? The indigenous 45 population of the region are broadly classified as Melanesian, Polynesian and Micronesians, on October 1, 2021 by guest. Protected copyright. 46 each with their own diverse historical roots and cultures.12 Such diversity is accompanied by 47 differences in economic development and living standards, causing a wide variation in health 48 outcomes between populations.12 Consequently, this review will also describe the prevalence 49 50 and risk factors by sub-population group. 51 52 Stage two: Identifying relevant studies 53 The second stage of the review aims to identify the relevant studies through the eligibility 54 criteria, and search strategies involved. The Arksey and O’Malley’s methodological 55 framework25 uses Population-Concept-Context. For this review, the Population is defined as 56 57 all women of child-bearing age (15-49 years old) who gave birth in the Pacific Island region 58 and infants from these births; Concept is the prevalence and risk factors for adverse birth 59 outcomes (low birthweight, preterm birth, small for gestational age or fetal growth restriction, 60

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1 2 3 stillbirths and miscarriage); and Context is defined geographically as all 21 countries and 4

territories in the region. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 7 Inclusion and exclusion criteria 8 We will include all studies and articles irrespective of their study design. We will incorporate 9 all studies that report risk factors and their associations with one or more of the adverse birth 10 outcomes in the Pacific Island region arising during pregnancy but observed at the separation 11 of the fetus from the mother or shortly afterwards. We will include studies that will provide 12 estimates of the prevalence rates and risk factors of adverse birth outcomes. That include 13 14 inferential studies that aimed to estimate the prevalence and identify associated risk factors 15 such as intervention and observational studies. Our review will also include descriptive 16 population-based studies such as the Demographic Health Surveys and other surveys. We 17 will include studies from the 21 sovereign island states and territories of the region namely: 18 American Samoa, CookFor Islands, peer Easter Islands,review Federated onlyStates of Micronesia, Fiji, Guam, 19 Kiribati, Mariana Islands, Marshall Islands, Nauru, New Caledonia, Niue, Palau, Papua New 20 21 Guinea, Samoa, Solomon Islands, Tahiti, Tokelau, Tonga, Tuvalu, Vanuatu and Wallis and 14 22 Futuna. Both primary and secondary analytical studies published in peer-reviewed journals 23 and grey literature as government reports will be included. Studies published in English from 24 the year 2000 to February 2021 will be included. Table 1 illustrates a summary of the 25 inclusion and exclusion criteria for the study. 26 27 Search Strategy 28 The search strategy will follow the three-stage search process outlined by the Joanna Briggs 29 Institute.27 The first stage will include an initial search using key concept terms that will be 30 undertaken in CINAHL and Medline to identify MeSH or text terms contained within the 31 titles and abstracts of articles. The key concept terms are adverse birth outcomes, pregnancy 32 33 risk factors and Pacific Island region. Table 2 outlines the grid of key concepts and terms. 34 35 In the second stage of the search, all MeSH terms, key concept terms and their synonyms will 36 be combined with Boolean operators, truncations, and wildcards to generate search strings 37 and will be applied across the selected databases. The following electronic databases will be http://bmjopen.bmj.com/ 38 39 searched: CINAHL, Medline, ProQuest, SpringerLink and Scopus. As all databases have 40 different search protocols, we will ensure to follow each of their guidelines accordingly. In 41 the second stage, we will carry out two levels of searches. The first level will use general key 42 concept terms and their synonyms combined with MeSH terms identified. An example of 43 44 general search string designed for CINAHL is as follows; (“adverse birth outcome*” OR

45 “poor birth outcome*” OR “preterm birth*” OR “premature birth*” OR “Poor fetal growth*” on October 1, 2021 by guest. Protected copyright. 46 OR “fetal growth restriction*” OR “intrauterine growth retardation” OR “growth retardation” 47 OR “small baby*” OR “very small baby*”OR “low birth weight” OR “low birthweight” OR 48 “very low birth weight” OR “very low birthweight” OR “extremely low birth weight” OR 49 50 “extremely low birthweight” OR “stillbirth” OR “still birth”) OR (MH “pregnancy 51 outcome*” OR MH “infant very low birth weight” OR MH “outcome* of prematurity”) 52 AND (“pregnancy risk factor*” OR “adverse pregnancy outcome*” OR “poor pregnancy 53 outcome*” OR MH “risk factor*” OR MH “pregnancy risk*” OR MH “high risk*” OR MH 54 55 “pregnancy in adolescence*” OR MH “pregnancy risk*”) AND (“Pacific Island*” OR 56 “Oceania” OR “South Pacific Island*” OR “Pacific Island country*” OR “MH Pacific 57 Island*”). 58 Similarly, a specific search with more precise key terms or specific risk factors will narrow 59 60 the search down for each country. Specific search terms will be identified through the initial

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1 2 3 literature review to understand the specific risk factors within the population. An example of 4

specific key and MeSH terms and search strings also designed for CINAHL is as follows; BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 (“preterm birth*” OR “premature birth*” OR “Poor fetal growth*” OR “fetal growth 7 restriction*” OR “intrauterine growth retardation” OR “growth retardation” OR “small 8 baby*” OR “very small baby*” OR “low birth weight” OR “low birthweight” OR “very low 9 birth weight” OR “very low birthweight” OR “extremely low birth weight” OR “extremely 10 low birthweight” OR “stillbirth” OR “still birth”) OR (MH “pregnancy outcome*” OR MH 11 “infant very low birth weight” OR MH “outcome* of prematurity”) AND (“malaria in 12 pregnancy” OR “anaemia in pregnancy” OR “substance use” OR “alcohol use” OR “betel nut 13 14 use” OR “areca nut use” OR “tobacco use” OR “cigarette use” OR “maternal obesity” OR 15 “maternal malnutrition” OR “maternal undernutrition” OR “teenage pregnancy” ) AND 16 (“American Samoa” OR “Cook Island*” OR “Easter Island*” OR “Federated States of 17 Micronesia” OR “Fiji” OR “Guam” OR “Kiribati” OR “Mariana Island*” OR “Marshall 18 Island*” OR “Nauru”For OR “New peer Caledonia” review OR “Niue” OR only “Palau” OR “Papua New 19 Guinea” OR “Samoa” OR “Solomon Island*” OR “Tahiti” OR “Tokelau” OR “Tonga” OR 20 21 “Tuvalu” OR “Vanuatu” OR “Wallis and Futuna”). Table 3 illustrates a comprehensive 22 search of general and specific search terms combined with MeSH that will be applied to 23 CINAHL database. 24 25 In the third stage of the search, we will assess the reference lists of studies initially retrieved 26 in order to identify any relevant studies which have not been identified by the electronic 27 database searches. Additional searches will also be conducted to identify non-indexed studies 28 29 and manually searching thesis repositories, Google Scholar and Google for regional health 30 organisation websites. The online sources that we will search include the United Nations 31 International Children Emergency Fund, World Health Organisation, Pacific community and 32 individual countries health websites. 33 34 Stage three: Study selection 35 At this stage, we will screen and select the studies. During the primary review, we will 36

37 consolidate all studies retrieved, remove all duplicates and remove studies that do not http://bmjopen.bmj.com/ 38 correspond to the Population Concept Context criteria.28 Next, we will screen the titles and 39 abstracts of articles after importing all records retrieved from databases and web-based 40 searches into EndNote. Two reviewers (LK and GT ) will be conducting the study selection 41 and data abstraction.26 Any uncertainty with the title and abstract will go through full-text 42 review. Any uncertainty reached on any article will be discussed with the broader research 43 44 team. If consensus is not reached, articles will be excluded from the review. All remaining 29 45 articles will go through full-text screening, following the PRISMA flow chart and final on October 1, 2021 by guest. Protected copyright. 46 articles will proceed to the final review. 47 48 Stage four: Charting data 49 Data charting will involve data extraction and documenting from the final articles selected. 50 During the data extraction, all results will be entered into Excel spreadsheets alongside 51 52 standard bibliographic information that includes author(s), year of publication, origin or 53 country of origin, aims and purpose, study population, methodology, intervention type, 54 intervention duration, outcomes and details and key findings. Table 4 outlines the standard 55 bibliographic information.27 For each article, reviewed key information to be retrieved will be 56 risk factors matched to birth outcomes, prevalence to the specific context of the region. The 57 framework will be pilot tested by the reviewers to ensure that it is consistent with data 58 charting and the study aims and objectives. Charting of data will be an iterative process of 59 60 screening and extracting data that will be done mostly by the principal investigator. Any

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1 2 3 arising questions and uncertainty during the process will be discussed research team to reach 4

an agreement. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 7 Stage five: Collating, summarising, and presenting the results 8 In stage five, tabular presentation of the findings will be mapped from data extracted from the 9 selected articles, as outlined, (see table 4) and guided by Arskey and O’Malley.25 Findings 10 will be presented quantitatively in aggregated forms figure and qualitatively as thematic 11 narrative summaries, all of which will reflect the study objectives.25 The results of the studies 12 will not be compared but presented as a body of evidence. We expect to map a wide range of 13 14 risk factors, prevalence, and the different adverse birth outcomes against the countries’ 15 ethnic, and geographical diversity to provide the first such body of literature for the region. 16 17 Stage six: Stakeholder consultation 18 A consultation exerciseFor will bepeer conducted review online with relevant only health professionals in the 19 Solomon Islands, including midwives, paediatric nurses, obstetricians, and paediatricians 20 21 identified through contacts and purposive and snowball sampling. This stage aims to validate 22 findings from this study and to add additional insights and recommendations from their 23 perspectives. Consultation will be undertaken at the completion of the article review. The 24 exercise will involve the collection of quantitative and qualitative feedback from clinicians 25 who work with pregnant mothers and infants to obtain their knowledge and experience of risk 26 factors and birth outcomes in the Solomon Islands from a clinical perspective. Ten health 27 professionals working with pregnant woman and infants will be consulted. Selection will be 28 29 made by purposeful and snowball sampling. 30 31 Stage seven: Patient and public involvement 32 No patient involved. 33 34 Acknowledgements 35 36 The authors acknowledge the invaluable support and input from the librarian (Faculty of

37 Health Science of Curtin University), the reviewers (BMJ open) and our team of peer http://bmjopen.bmj.com/ 38 reviewers. 39 40 41 Contributorship Statement 42 LSKK, GFP, GAT and JJ: study inception, conceptualisation and design, LSKK: drafted the 43 first version and conducted the preliminary searches, collating all inputs reiteratively and 44 revision of the manuscript, GAT, JJ, HB, GKD, and GFP: critically reviewed the manuscript. 45 All authors read and approved the final version. on October 1, 2021 by guest. Protected copyright. 46 47 Email Addresses 48 49 Lydia S K. Kaforau [email protected] 50 Gizachew A. Tessema [email protected] 51 Jonine Jancey [email protected] 52 Gursimran K. Dhamrait [email protected] 53 Hugo Bugoro [email protected] 54 Gavin Pereira [email protected] 55 56 57 Competing interests 58 None declared. 59 60

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1 2 3 Funding 4 Article Processing Charge (APC) waiver claim 00164914. Full waiver grant number 00D0YaQIK. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 _5001v1P90VA. 6 National Health and Medical Research Council Grants. #1099655 to GP, #1173991 to GP, #1195716 7 8 to GAT. 9 Research Council of Norway Grants #262700 to GP 10 11 Ethics and Dissemination 12 There will be no direct contact with human or patients in the case of the scoping review; 13 therefore, no ethics will be required. However, we will seek ethical approval from the 14 Research Ethics Office of Curtin University and the Health Research and Ethics Committee 15 in the Solomon Islands for stakeholder consultation. Dissemination will be made through 16 17 regional conferences and publication in peer-reviewed journals. 18 For peer review only 19 20 Reference 21 1. Weng Y-H, Yang C-Y, Chiu Y-W. Risk Assessment of Adverse Birth Outcomes in Relation to 22 Maternal Age. PLOS ONE 2014;9(12):e114843. doi: 10.1371/journal.pone.0114843 23 24 2. Berhan T, Andargachew K. Prevalence of adverse birth outcome and associated factors among 25 women who delivered in Hawassa town governmental health institutions, south Ethiopia, in 26 2017. Reproductive Health 2018;15(1):1-10. 27 3. Sayers SM, Lancaster PAL, Whitehead CL. Fetal Growth Restriction: Causes and Outcomes. In: 28 Quah SR, ed. International Encyclopedia of Public Health (Second Edition). Oxford: Academic 29 Press, 2017:132-42. 30 4. Tesfahun MW, Nigus BY, Asmamaw DB. Risk factors for low birth weight in hospitals of North 31 Wello zone, Ethiopia: A case-control study. PLoS One 2019;14(3) doi: 32 33 org/10.1371/journal.pone.0213054 34 5. Tampah-Naah AM, Anzagra L, Yendaw E. Factors Correlated with Low Birth Weight in Ghana. 35 British Journal of Medicine & Medical Research 2016;16(4):1-8. doi: 36 10.9734/BJMMR/2016/24881 [published Online First: 8th June 2016] 37 6. Su D, Samson K, Garg A, et al. Birth history as a predictor of adverse birth outcomes: Evidence http://bmjopen.bmj.com/ 38 from state vital statistics data. Preventive Medicine Reports 2018;11:63-68. 39 7. Adane AA, Ayele TA, Ararsa LG, et al. Adverse birth outcomes among deliveries at Gondar 40 University Hospital, Northwest Ethiopia. bmc pregnancy and childbirth 2014;14(1):90-90. 41 42 8. Tsegaye B, Kassa A. Prevalence of adverse birth outcome and associated factors among women 43 who delivered in Hawassa town governmental health institutions, south Ethiopia, in 2017. 44 Reproductive health 2018;15(1):193-93. doi: 10.1186/s12978-018-0631-3

45 9. Chawanpaiboon S, Vogel JP, Moller A-B, et al. Global, regional, and national estimates of levels of on October 1, 2021 by guest. Protected copyright. 46 preterm birth in 2014: a systematic review and modelling analysis. The Lancet Global Health 47 2019;7(1):e37-e46. 48 10. Charlton KE, Russell J, Gorman E, et al. Fish, food security and health in Pacific Island countries 49 and territories: a systematic literature review. BMC Public Health 2016;16(1):285. 50 11. Dongarwar D, Salihu HM. Place of Residence and Inequities in Adverse Pregnancy and Birth 51 52 Outcomes in India. Int J MCH AIDS 2020;9(1):53-63. [published Online First: 2019/12/28] 53 12. Horwood PF, Tarantola A, Goarant C, et al. Health Challenges of the Pacific Region: Insights From 54 History, Geography, Social Determinants, Genetics, and the Microbiome. Frontiers in 55 Immunology 2019;10(2184) 56 13. OECD, Organisation WH. Health at a Glance: Asia/Pacific 2018, 2018. 57 14. Linhart C, Karen Carter, Renee Sorchik, et al. Trends in Neonatal and Infant Mortality for Pacific 58 Island States. Secretariat of the Pacific Community cataloguing-in-publication data, 2015. 59 60

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1 2 3 15. Lee ACC, Katz J, Blencowe H, et al. National and regional estimates of term and preterm babies 4 born small for gestational age in 138 low-income and middle-income countries in 2010. The 5 BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 Lancet Global Health 2013;1(1):e26-e36. 7 16. Yakoob MY, Lawn JE, Darmstadt GL, et al. Stillbirths: Epidemiology, Evidence, and Priorities for 8 Action. Seminars in Perinatology 2010;34(6):387-94. 9 17. WHO. Country Cooperation Strategy at a Glance 2013. 10 18. Andrew NL, Bright P, de la Rua L, et al. Coastal proximity of populations in 22 Pacific Island 11 Countries and Territories. PLOS ONE 2019;14(9):e0223249. 12 19. Quinn B, Peach E, Wright CJC, et al. Alcohol and other substance use among a sample of young 13 people in the Solomon Islands Australian and New Zealand Journal of Public Health 2017;42( 14 4):358-64. 15 16 20. Pratt S. The Challenge of Betel Nut Consumption to Economic Development: a Case of Honiara, 17 Solomon Islands. 2014;21:103. 18 21. Jarawan E, CarpioFor C. Health peer Challenges inreview the Small Island Developingonly Countries of the Pacific and 19 the Caribbean, ( ? ):37. 20 22. De Silva M, Panisi L, Brownfoot FC, et al. Systematic review of areca (betel nut) use and adverse 21 pregnancy outcomes. International Journal of Gynecology & Obstetrics 2019;147(3):292-300. 22 23. Berger KE, Masterson J, Mascardo J, et al. The Effects of Chewing Betel Nut with Tobacco and 23 Pre-pregnancy Obesity on Adverse Birth Outcomes Among Palauan Women. Maternal and 24 25 Child Health Journal 2016;20(8):1696-703. doi: 10.1007/s10995-016-1972-6 26 24. Aromataris E, Munn Z. JBI Reviewer's Manual. Joana Briggs Institute: Joana Briggs Institute, 27 2020:488. 28 25. Arksey H, O'Malley L. Scoping studies: towards a methodological framework. International 29 Journal of Social Research Methodology 2005;8(1):19-32. 30 26. Levac D, Colquhoun H, O'Brien KK. Scoping studies: advancing the methodology. Implementation 31 Science 2010;5(1):69. doi: 10.1186/1748-5908-5-69 32 27. Peters M, Godfrey C, Khalil H, et al. 2017 Guidance for the Conduct of JBI Scoping Reviews, 2017. 33 28. Halas G, Schultz ASH, Rothney J, et al. A scoping review protocol to map the research foci trends 34 35 in tobacco control over the last decade. BMJ Open 2015;5(1):e006643-e43. 36 29. Moher D, Liberati A, Tetzlaff J, et al. Preferred Reporting Items for Systematic Reviews and Meta-

37 Analyses: The PRISMA Statement. PLOS Medicine 2009;6(7):e1000097. http://bmjopen.bmj.com/ 38 39 40 Table 1. Inclusion and exclusion criteria 41 Inclusion criteria Exclusion criteria 42 43 -All studies and articles irrespective of -Studies on Pacific Islanders living in 44 their designs countries outside the region 45 -Primary and secondary studies -Studies on Non-Pacific Islanders living in the on October 1, 2021 by guest. Protected copyright. 46 -Population and inferential based studies Pacific Islands 47 -Mother and infants’ populations -Studies before the year 2000 48 -21 Pacific Island countries and territories 49 50 -Articles published from the year 2000 to 51 current 52 53 Table 2. Grid of key concepts and terms 54 Concept 1 Concept 2 Concept 3 55 Adverse birth outcomes AND Pregnancy Risk factors AND Pacific Island region 56 57 58 59 60

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1 2 3 Table 3. CINAHL Searches 4 5  Key concepts and terms. BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 6 The following key concepts were identified from the topic. 7 Concept 1 Concept 2 Concept 3 8 Adverse birth outcomes OR Pregnancy risk factors AND Pacific Island region 9 10 11  MeSH and subject headings identified. 12 Key concept terms CINAHL 13 Adverse birth MH “Pregnancy outcome*” OR MH “Infant very Low birth 14 outcomes weight” OR MH “Outcome* of prematurity” 15 Pregnancy Risk MH “Risk factor*” OR MH “Pregnancy risk” OR MH “High 16 17 Factors risk*” OR MH “Pregnancy in adolescence” OR MH 18 For “Pregnancypeer risk*” review only 19 Pacific Island region MH “Pacific Island*” 20 21  Search strings developed 22 23 #1. Key concept and general terms and synonyms search string 24 (“adverse birth outcome*” OR “poor birth outcome*” OR “preterm birth*” OR “premature 25 birth*” OR “Poor fetal growth*” OR “fetal growth restriction*” OR “intrauterine growth 26 retardation” OR “growth retardation” OR “low birth weight” OR “low birthweight” OR 27 “very low birth weight” OR “very low birthweight” OR “extremely low birth weight” OR 28 “extremely low birthweight” OR “stillbirth” OR “still birth”) AND (“pregnancy risk 29 factor*” OR “adverse pregnancy outcome*” OR “poor pregnancy outcome*”) AND 30 31 (“Pacific Island*” OR “Oceania” OR “South Pacific Island*” OR “Pacific Island 32 country*”) 33 34 #2. MeSH terms search string 35 (MH “pregnancy outcome*” OR MH “infant very low birth weight” OR MH “outcome* of 36 prematurity”) AND (MH “risk factor*” OR MH “pregnancy risk*” OR MH “high risk*” 37 OR MH “pregnancy in adolescence*” OR MH “pregnancy risk*”) AND (“MH Pacific http://bmjopen.bmj.com/ 38 Island*”) 39 40 #3. General and MeSH terms combined search string 41 42 (“adverse birth outcome*” OR “poor birth outcome*” OR “preterm birth*” OR “premature 43 birth*” OR “Poor fetal growth*” OR “fetal growth restriction*” OR “intrauterine growth 44 retardation” OR “growth retardation” OR “small baby*” OR “very small baby*”OR “low 45 birth weight” OR “low birthweight” OR “very low birth weight” OR “very low on October 1, 2021 by guest. Protected copyright. 46 47 birthweight” OR “extremely low birth weight” OR “extremely low birthweight” OR 48 “stillbirth” OR “still birth”) OR (MH “pregnancy outcome*” OR MH “infant very low 49 birth weight” OR MH “outcome* of prematurity”) AND (“pregnancy risk factor*” OR 50 “adverse pregnancy outcome*” OR “poor pregnancy outcome*” OR MH “risk factor*”OR 51 52 MH “pregnancy risk*” OR MH “high risk*” OR MH “pregnancy in adolescence*” OR 53 MH “pregnancy risk*”) AND (“Pacific Island*” OR “Oceania” OR “South Pacific 54 Island*” OR “Pacific Island country*” OR “MH Pacific Island*”) 55 56 #4. Specific and MeSH terms combined search string 57 (“preterm birth*” OR “premature birth*” OR “Poor fetal growth*” OR “fetal growth 58 restriction*” OR “intrauterine growth retardation” OR “growth retardation” OR “small 59 baby*” OR “very small baby*” OR “low birth weight” OR “low birthweight” OR “very 60

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1 2 3 low birth weight” OR “very low birthweight” OR “extremely low birth weight” OR 4

“extremely low birthweight” OR “stillbirth” OR “still birth”) OR (MH “pregnancy BMJ Open: first published as 10.1136/bmjopen-2020-042423 on 8 April 2021. Downloaded from 5 6 outcome*” OR MH “infant very low birth weight” OR MH “outcome* of prematurity”) 7 AND (“malaria in pregnancy” OR “anaemia in pregnancy” OR “substance use” OR 8 “alcohol use” OR “betel nut use” OR “areca nut use” OR “tobacco use” OR “cigarette use” 9 OR “maternal obesity” OR “maternal malnutrition” OR “maternal undernutrition” OR 10 “teenage pregnancy” ) AND (“American Samoa” OR “Cook Island*” OR “Easter Island*” 11 OR “Federated States of Micronesia” OR “Fiji” OR “Guam” OR “Kiribati” OR “Mariana 12 13 Island*” OR “Marshall Island*” OR “Nauru” OR “New Caledonia” OR “Niue” OR 14 “Palau” OR “Papua New Guinea” OR “Samoa” OR “Solomon Island*” OR “Tahiti” OR 15 “Tokelau” OR “Tonga” OR “Tuvalu” OR “Vanuatu” OR “Wallis and Futuna”) 16 17 Filter/limiter used 18 -Year inclusion 2000-currentFor peer review only 19 -Full-text articles 20 21 -English language 22 -Medical subject headings 23 24 Table 4. Data extraction table 25 26 Main category 27 a) Author(s) 28 b) Year of publication 29 c) Origin/country study was conducted 30 d) Study design: 31 32 e) Aims/purpose 33 f) Sampling strategy 34 g) Study population 35 h) Sample size 36

37 i) Methodology http://bmjopen.bmj.com/ 38 j) Intervention/exposure type (if applicable) and comparison group (if applicable) 39 k) Duration of the exposure/intervention (if applicable) 40 l) Outcomes assessment and method to assess associations (if applicable) 41 m) Key findings that relate to the scoping review question/s 42 43 44

45 on October 1, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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