Fast-track referral for health interventions during pregnancy: study protocol of a randomised pragmatic experimental study to reduce low birth weight in Portugal (STOP LBW)

Henrique Barros, Ines Baia, Teresa Monjardino, Pedro Pimenta, Ana Alfredo, Anzhela Sorokina, Rosa Domingues, Henrique Barros, Ines Baia, Teresa Monjardino, Pedro Pimenta, Ana Alfredo, Anzhela Sorokina, Rosa Domingues

Abstract

Introduction: Low birth weight (LBW) is associated with a wide range of short-term and long-term consequences and is related to maternal psychosocial and behavioural determinants. The objective of this study is to estimate the effect of implementing fast-track referral for early intervention on psychosocial and behavioural risk factors-smoking, alcohol consumption, depression and physical violence-in reducing the incidence of LBW.

Methods and analysis: Parallel superiority pragmatic clinical trial randomised by clusters. Primary healthcare units (PHCU) located in Portugal will be randomised (1:1) to intervention or control groups. Pregnant women over 18 years of age attending these PHCU will be eligible to the study. Risk factors will be assessed through face-to-face interviews. In the intervention group, women who report at least one risk factor will have immediate access to referral services. The comparison group will be the local standard of care for these risk factors. We will use intention-to-treat analyses to compare intervention and control groups. We estimated a sample size of 2832 pregnant women to detect a 30% reduction in the incidence rate of LBW between the control and intervention groups. Secondary outcomes are the reduction of preterm births, reduction of the four risk factors and acceptance of the intervention.

Ethics and dissemination: The study was approved by the Ethics Committee of the Public Health Institute of the University of Porto (no CE20140). The findings will be disseminated to the public, the funders, health professionals, health managers and other researchers.

Trial registration number: NCT04866277.

Keywords: alcohol drinking; clinical trial; depression; infant, low birth weight; physical abuse; smoking.

Conflict of interest statement

Competing interests: The authors declare no conflict of interests

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow diagram showing study design, measures and sample size.

References

    1. Hughes MM, Black RE, Katz J. 2500-g low birth weight cutoff: history and implications for future research and policy. Matern Child Health J 2017;21:283–9. 10.1007/s10995-016-2131-9
    1. United Nations Children’s Fund and World Health Organization . Low Birthweight: Country, regional and global estimates. New York: UNICEF, 2004.
    1. Blencowe H, Krasevec J, de Onis M, et al. . National, regional, and worldwide estimates of low birthweight in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health 2019;7:e849–60. 10.1016/S2214-109X(18)30565-5
    1. Institute for Health Metrics and Evaluation (IHME) . GBD compare data visualization. Seattle: WA: IHME, University of Washington, 2016.
    1. Jaddoe VWV, Witteman JCM. Hypotheses on the fetal origins of adult diseases: contributions of epidemiological studies. Eur J Epidemiol 2006;21:91–102. 10.1007/s10654-005-5924-5
    1. Knop MR, Geng T-T, Gorny AW, et al. . Birth Weight and Risk of Type 2 Diabetes Mellitus, Cardiovascular Disease, and Hypertension in Adults: A Meta-Analysis of 7 646 267 Participants From 135 Studies. J Am Heart Assoc 2018;7:e008870. 10.1161/JAHA.118.008870
    1. World Health Organization, Resolution WHA65.6 . Comprehensive implementation plan on maternal, infant and young child nutrition. in: Sixty-fifth World health assembly Geneva. 2012. Geneva: Resolutions and decisions Geneva WHO annexes, 2012: 12–13.
    1. World Health Organization . Comprehensive implementation plan on maternal, infant and young child nutrition, 2014. Available: [Accessed April 2019].
    1. Martin JA, Hamilton BE, Osterman MJK. Births: final data for 2017. National Vital Statistics Reports 2018;67:1–50.
    1. OECD health statistics, 2019. Available: [Accessed January 2020].
    1. Dominguez TP, Race DTP. Race, racism, and racial disparities in adverse birth outcomes. Clin Obstet Gynecol 2008;51:360–70. 10.1097/GRF.0b013e31816f28de
    1. PORDATA, 2020. Available: [Accessed November 2021].
    1. Villar J, Papageorghiou AT, Knight HE, et al. . The preterm birth syndrome: a prototype phenotypic classification. Am J Obstet Gynecol 2012;206:119–23. 10.1016/j.ajog.2011.10.866
    1. Kramer MS. Determinants of low birth weight: methodological assessment and meta-analysis. Bull World Health Organ 1987;65:663–737.
    1. Johnson CD, Jones S, Paranjothy S. Reducing low birth weight: prioritizing action to address modifiable risk factors. J Public Health 2017;39:122–31. 10.1093/pubmed/fdv212
    1. Yan J, Groothuis PA. Timing of prenatal smoking cessation or reduction and infant birth weight: evidence from the United Kingdom millennium cohort study. Matern Child Health J 2015;19:447–58. 10.1007/s10995-014-1516-x
    1. Pereira PPdaS, Da Mata FAF, Figueiredo ACG, et al. . Maternal active smoking during pregnancy and low birth weight in the Americas: a systematic review and meta-analysis. Nicotine Tob Res 2017;19:497–505. 10.1093/ntr/ntw228
    1. Kharkova OA, Grjibovski AM, Krettek A, et al. . Effect of smoking behavior before and during pregnancy on selected birth outcomes among singleton full-term pregnancy: a Murmansk County birth registry study. Int J Environ Res Public Health 2017;14. 10.3390/ijerph14080867. [Epub ahead of print: 02 08 2017].
    1. Xaverius PK, O'Reilly Z, Li A, et al. . Smoking cessation and pregnancy: timing of cessation reduces or eliminates the effect on low birth weight. Matern Child Health J 2019;23:1434–41. 10.1007/s10995-019-02751-2
    1. Patra J, Bakker R, Irving H, et al. . Dose-response relationship between alcohol consumption before and during pregnancy and the risks of low birthweight, preterm birth and small for gestational age (SGA)-a systematic review and meta-analyses. BJOG 2011;118:1411–21. 10.1111/j.1471-0528.2011.03050.x
    1. Strandberg-Larsen K, Poulsen G, Bech BH, et al. . Association of light-to-moderate alcohol drinking in pregnancy with preterm birth and birth weight: elucidating bias by pooling data from nine European cohorts. Eur J Epidemiol 2017;32:751–64. 10.1007/s10654-017-0323-2
    1. Jarde A, Morais M, Kingston D, et al. . Neonatal outcomes in women with untreated antenatal depression compared with women without depression: a systematic review and meta-analysis. JAMA Psychiatry 2016;73:826–37. 10.1001/jamapsychiatry.2016.0934
    1. Dadi AF, Miller ER, Bisetegn TA, et al. . Global burden of antenatal depression and its association with adverse birth outcomes: an umbrella review. BMC Public Health 2020;20:173. 10.1186/s12889-020-8293-9
    1. Donovan BM, Spracklen CN, Schweizer ML, et al. . Intimate partner violence during pregnancy and the risk for adverse infant outcomes: a systematic review and meta-analysis. BJOG 2016;123:1289–99. 10.1111/1471-0528.13928
    1. Hill A, Pallitto C, McCleary-Sills J, et al. . A systematic review and meta-analysis of intimate partner violence during pregnancy and selected birth outcomes. Int J Gynaecol Obstet 2016;133:269–76. 10.1016/j.ijgo.2015.10.023
    1. Salmasi G, Grady R, Jones J, et al. . Environmental tobacco smoke exposure and perinatal outcomes: a systematic review and meta-analyses. Acta Obstet Gynecol Scand 2010;89:423–41. 10.3109/00016340903505748
    1. Saúde D-Gda. Portugal - Prevenção e Controlo do Tabagismo em Números - 2015. Lisboa: DGS, 2016.
    1. Tojal C, Costa R. Anxiety and depression symptoms among pregnant women with different smoking habits. Psychol Health Med 2020;25:410–7. 10.1080/13548506.2019.1634820
    1. Alves E, Azevedo A, Correia S. Long-Term maintenance of smoking cessation in pregnancy: an analysis of the birth cohort generation XXI. Nicotine &Tobacco Research 2013;15:1598–607.
    1. Teixeira C, Al Hamwi S, Carrapatoso M, et al. . Tobacco use during pregnancy among native and migrant women in Portugal. results from the Bambino study. Revue d'Épidémiologie et de Santé Publique 2018;66:S358–9. 10.1016/j.respe.2018.05.333
    1. Ornoy A, Ergaz Z. Alcohol abuse in pregnant women: effects on the fetus and newborn, mode of action and maternal treatment. Int J Environ Res Public Health 2010;7:364–79. 10.3390/ijerph7020364
    1. Pinto E, Barros H, dos Santos Silva I. Dietary intake and nutritional adequacy prior to conception and during pregnancy: a follow-up study in the North of Portugal. Public Health Nutr 2009;12:922–31. 10.1017/S1368980008003595
    1. Carapinha L, Ribeiro C, Lavado E. O consumo de álcool Na gravidez. Lisboa: SICAD, 2015.
    1. Dunkel Schetter C. Psychological science on pregnancy: stress processes, biopsychosocial models, and emerging research issues. Annu Rev Psychol 2011;62:531–58. 10.1146/annurev.psych.031809.130727
    1. Zuckerman B, Amaro H, Bauchner H, et al. . Depressive symptoms during pregnancy: relationship to poor health behaviors. Am J Obstet Gynecol 1989;160:1107–11. 10.1016/0002-9378(89)90170-1
    1. Maia BR, Marques M, Bos S. Epidemiology of perinatal depression in Portugal: categorical and dimensional approach. Acta Med Port 2011;24 Suppl 2:443–8.
    1. Figueiredo B, Conde A. Anxiety and depression in women and men from early pregnancy to 3-months postpartum. Arch Womens Ment Health 2011;14:247–55. 10.1007/s00737-011-0217-3
    1. Bailey BA. Partner violence during pregnancy: prevalence, effects, screening, and management. Int J Womens Health 2010;2:183–97. 10.2147/IJWH.S8632
    1. Rodrigues T, Rocha L, Barros H. Physical abuse during pregnancy and preterm delivery. American Journal of Obstetrics & Gynecology 2008;198:171:e1–6.
    1. Almeida FSJ, Coutinho EC, Duarte JC, et al. . Domestic violence in pregnancy: prevalence and characteristics of the pregnant woman. J Clin Nurs 2017;26:2417–25. 10.1111/jocn.13756
    1. Patnode CD, Henderson JT, Thompson JH, et al. . Behavioral counseling and pharmacotherapy interventions for tobacco cessation in adults, including pregnant women: a review of reviews for the U.S. preventive services Task force. Ann Intern Med 2015;163:608–21. 10.7326/M15-0171
    1. Chamberlain C, O'Mara-Eves A, Porter J, et al. . Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev 2017;2:CD001055. 10.1002/14651858.CD001055.pub5
    1. Stade BC, Bailey C, Dzendoletas D, et al. . Psychological and/or educational interventions for reducing alcohol consumption in pregnant women and women planning pregnancy. Cochrane Database Syst Rev 2009:CD004228. 10.1002/14651858.CD004228.pub2
    1. Fergie L, Campbell KA, Coleman-Haynes T, et al. . Identifying effective behavior change techniques for alcohol and illicit substance use during pregnancy: a systematic review. Ann Behav Med 2019;53:769–81. 10.1093/abm/kay085
    1. Morrell CJ, Sutcliffe P, Booth A, et al. . A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression. Health Technol Assess 2016;20:1–414. 10.3310/hta20370
    1. Nair U, Armfield NR, Chatfield MD, et al. . The effectiveness of telemedicine interventions to address maternal depression: a systematic review and meta-analysis. J Telemed Telecare 2018;24:639–50. 10.1177/1357633X18794332
    1. O'Connor E, Senger CA, Henninger ML, et al. . Interventions to prevent perinatal depression: evidence report and systematic review for the US preventive services Task force. JAMA 2019;321:588–601. 10.1001/jama.2018.20865
    1. Poyatos-León R, García-Hermoso A, Sanabria-Martínez G, et al. . Effects of exercise-based interventions on postpartum depression: a meta-analysis of randomized controlled trials. Birth 2017;44:200–8. 10.1111/birt.12294
    1. Jahanfar S, Howard LM, Medley N, et al. . Interventions for preventing or reducing domestic violence against pregnant women. Cochrane Database Syst Rev 2014;34:CD009414. 10.1002/14651858.CD009414.pub3
    1. Daley D, McCauley M, van den Broek N. Interventions for women who report domestic violence during and after pregnancy in low- and middle-income countries: a systematic literature review. BMC Pregnancy Childbirth 2020;20:141. 10.1186/s12884-020-2819-0
    1. Ricketts SA, Murray EK, Schwalberg R. Reducing low birthweight by resolving risks: results from Colorado's prenatal plus program. Am J Public Health 2005;95:1952–7. 10.2105/AJPH.2004.047068
    1. El-Mohandes AAE, Kiely M, Gantz MG, et al. . Very preterm birth is reduced in women receiving an integrated behavioral intervention: a randomized controlled trial. Matern Child Health J 2011;15:19–28. 10.1007/s10995-009-0557-z
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. . Spirit 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586. 10.1136/bmj.e7586
    1. Ferreira PL, Quintal C, Lopes I. Teste de dependência nicotina: validação linguística E psicométrica do teste de Fagerström. Revista Portuguesa de Saúde Pública 2009;27:37–56.
    1. Bush K, Kivlahan DR, McDonell MB, et al. . The audit alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. ambulatory care quality improvement project (ACQUIP). alcohol use disorders identification test. Arch Intern Med 1998;158:1789–95. 10.1001/archinte.158.16.1789
    1. Burns E, Gray R, Smith LA. Brief screening questionnaires to identify problem drinking during pregnancy: a systematic review. Addiction 2010;105:601–14.
    1. Areias ME, Kumar R, Barros H, et al. . Comparative incidence of depression in women and men, during pregnancy and after childbirth. validation of the Edinburgh postnatal depression scale in Portuguese mothers. Br J Psychiatry 1996;169:30–5. 10.1192/bjp.169.1.30
    1. Tendais I, Costa R, Conde A, et al. . Screening for depression and anxiety disorders from pregnancy to postpartum with the EPDS and STAI. Span J Psychol 2014;17:E7. 10.1017/sjp.2014.7
    1. Basile K, Hertz M, Back S. Intimate partner violence and sexual violence victimization assessment instruments for use in healthcare settings: version 1. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2007.
    1. Adams G, Gulliford MC, Ukoumunne OC, et al. . Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol 2004;57:785–94. 10.1016/j.jclinepi.2003.12.013
    1. Pereira M, Azevedo A, Lunet N, et al. . Explaining the decline in coronary heart disease mortality in Portugal between 1995 and 2008. Circulation 2013;6:634–42. 10.1161/CIRCOUTCOMES.113.000264
    1. Lisi C, De Freitas C, Barros H. Maternal country of birth and exclusive breastfeeding during the first in-hospital day in Portugal: the influence of the Baby-Friendly Hospital initiative. J Hum Lact 2021;37:147–57. 10.1177/0890334420982248

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir