Antenatal detection of large-for-gestational-age fetuses following implementation of the Growth Assessment Protocol: secondary analysis of a randomised control trial.


Journal

BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741

Informations de publication

Date de publication:
09 2023
Historique:
revised: 06 02 2023
received: 16 10 2022
accepted: 24 02 2023
medline: 3 8 2023
pubmed: 1 4 2023
entrez: 31 3 2023
Statut: ppublish

Résumé

To determine whether the Growth Assessment Protocol (GAP) affects the antenatal detection of large for gestational age (LGA) or maternal and perinatal outcomes amongst LGA babies. Secondary analysis of a pragmatic open randomised cluster control trial comparing the GAP with standard care. Eleven UK maternity units. Pregnant women and their LGA babies born at ≥36 Clusters were randomly allocated to GAP implementation or standard care. Data were collected from electronic patient records. Trial arms were compared using summary statistics, with unadjusted and adjusted (two-stage cluster summary approach) differences. Rate of detection of LGA (estimated fetal weight on ultrasound scan above the 90th centile after 34 A total of 506 LGA babies were exposed to GAP and 618 babies received standard care. There were no significant differences in the rate of LGA detection (GAP 38.0% vs standard care 48.0%; adjusted effect size -4.9%; 95% CI -20.5, 10.7; p = 0.54), nor in any of the maternal or perinatal outcomes. The use of GAP did not change the rate of antenatal ultrasound detection of LGA when compared with standard care.

Identifiants

pubmed: 36999234
doi: 10.1111/1471-0528.17453
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1167-1176

Subventions

Organisme : Guy's and St Thomas' Charity
ID : MAJ150704
Organisme : Stillborn and Neonatal Death Charity
ID : RG1011/16
Organisme : Tommy's Baby Charity

Informations de copyright

© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.

Références

Jolly MC, Sebire NJ, Harris JP, Regan L, Robinson S. Risk factors for macrosomia and its clinical consequences: a study of 350,311 pregnancies. Eur J Obstet Gynecol Reprod Biol. 2003;111(1):9-14.
American College of Obstetricians and Gynecologists. Fetal macrosomia. ACOG practice bulletin no. 22. Washington: ACOG; 2000.
Persson M, Pasupathy D, Hanson U, Norman M. Disproportionate body composition and perinatal outcome in large-for-gestational-age infants to mothers with type 1 diabetes. BJOG. 2012;119(5):565-72.
Ballard JL, Rosenn B, Khoury JC, Miodovnik M. Diabetic fetal macrosomia: significance of disproportionate growth. J Pediatr. 1993;122(1):115-9.
Vieira MC, McCowan LME, North RA, Myers JE, Walker JJ, Baker PN, et al. Antenatal risk factors associated with neonatal morbidity in large-for-gestational-age infants: an international prospective cohort study. Acta Obstet Gynecol Scand. 2018;97(8):1015-24.
Mondestin MA, Ananth CV, Smulian JC, Vintzileos AM. Birth weight and fetal death in the United States: the effect of maternal diabetes during pregnancy. Am J Obstet Gynecol. 2002;187(4):922-6.
National Institute for Health and Care Excellence. Antenatal care for uncomplicated pregnancies 2008 [cited 2020 Jul 02]. Available from: https://www.nice.org.uk/Guidance/CG62.
Macrosomia: ACOG practice bulletin, number 216. Obstet Gynecol. 2020;135(1):e18-35.
National Institute for Health and Care Excellence. Diabetes in pregnancy: management from preconception to the postnatal period. London: NICE; 2015.
Denison FC, Aedla NR, Keag O, Hor K, Reynolds RM, Milne A, et al. Care of women with obesity in pregnancy: green-top guideline no. 72. BJOG. 2019;126(3):e62-106.
Royal College of Obstetricians & Gynaecologists . Small for gestational age fetus: investigation & management. Green-top guideline no. 31. 2nd ed. London: RCOG Press; 2013 [cited 2020 July 02]. Available from: https://www.rcog.org.uk/guidance/browse-all-guidance/green-top-guidelines/small-for-gestational-age-fetus-investigation-and-management-green-top-guideline-no-31/.
Malin GL, Bugg GJ, Takwoingi Y, Thornton JG, Jones NW. Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta-analysis. BJOG. 2016;123(1):77-88.
Scioscia M, Vimercati A, Ceci O, Vicino M, Selvaggi LE. Estimation of birth weight by two-dimensional ultrasonography: a critical appraisal of its accuracy. Obstet Gynecol. 2008;111(1):57-65.
Zafman KB, Bergh E, Fox NS. Accuracy of sonographic estimated fetal weight in suspected macrosomia: the likelihood of overestimating and underestimating the true birthweight. J Matern Fetal Neonatal Med. 2020;33(6):967-72.
Wastlund D, Moraitis A, Thornton J, Sanders J, White I, Brocklehurst P, et al. The cost-effectiveness of universal late-pregnancy screening for macrosomia in nulliparous women: a decision analysis. BJOG. 2019;126(10):1243-50.
Reid EW, McNeill JA, Holmes VA, Alderdice FA. Women's perceptions and experiences of fetal macrosomia. Midwifery. 2014;30(4):456-63.
Perinatal Institute. National uptake of GAP [cited 2021 May 28]. Available from: https://perinatal.org.uk/Gap/Uptake
Cowan FJ, McKinlay CJD, Taylor RS, Wilson J, McAra-Couper J, Garrett N, et al. Detection of small for gestational age babies and perinatal outcomes following implementation of the growth assessment protocol at a New Zealand tertiary facility: an observational intervention study. Aust N Z J Obstet Gynaecol. 2021;61(3):339-46.
Relph S, Coxon K, Vieira M, Copas A, Healey A, Alagna A, et al. Effect of the growth assessment protocol on the detection of the small for gestational age fetus: process evaluation from the DESiGN cluster randomised trial. Implement Sci. 2022;17(1):60.
Vieira MC, Relph S, Copas A, Healey A, Coxon K, Alagna A, et al. The DESiGN trial (DEtection of small for gestational age neonate), evaluating the effect of the growth assessment protocol (GAP): study protocol for a randomised controlled trial. Trials. 2019;20(1):154.
Vieira MC, Relph S, Muruet-Gutierrez W, Elstad M, Coker B, Moitt N, et al. Evaluation of the growth assessment protocol (GAP) for antenatal detection of small for gestational age: the DESiGN cluster randomised trial. PLoS Med. 2022;19(6):e1004004.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, Group C. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.
Perinatal Institute. GROW-App UK [cited 2019 Jun 14]. Available from: https://app.growservice.org/uk/
Cole TJ, Freeman JV, Preece MA. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Stat Med. 1998;17(4):407-29.
Relph S, Elstad M, Coker B, Vieira MC, Moitt N, Gutierrez WM, et al. Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial-data management experience from the DESiGN trial team. Trials. 2021;22(1):195.
Hadlock FP, Harrist RB, Martinez-Poyer J. In utero analysis of fetal growth: a sonographic weight standard. Radiology. 1991;181(1):129-33.
Hooper R, Forbes A, Hemming K, Takeda A, Beresford L. Analysis of cluster randomised trials with an assessment of outcome at baseline. BMJ. 2018;360:k1121.
National Institute for Health and Care Excellence. Intrapartum care for women with existing medical conditions or obstetric complications and their babies. 2019 [cited 2021 Jan 05]. Available from: https://www.nice.org.uk/guidance/ng121
Moraitis AA, Shreeve N, Sovio U, Brocklehurst P, Heazell AEP, Thornton JG, et al. Universal third-trimester ultrasonic screening using fetal macrosomia in the prediction of adverse perinatal outcome: a systematic review and meta-analysis of diagnostic test accuracy. PLoS Med. 2020;17(10):e1003190.
Verger C, Moraitis AA, Barnfield L, Sovio U, Bamfo JEAK. Performance of different fetal growth charts in prediction of large-for-gestational age and associated neonatal morbidity in multiethnic obese population. Ultrasound Obstet Gynecol. 2020;56(1):73-7.
Clifford S, Giddings S, South M, Williams M, Gardosi J. The growth assessment protocol: a national programme to improve patient safety in maternity care. MIDIRS Midwifery Digest. 2013;23(4):516-23.
Melamed N, Yogev Y, Meizner I, Mashiach R, Ben-Haroush A. Sonographic prediction of fetal macrosomia: the consequences of false diagnosis. J Ultrasound Med. 2010;29(2):225-30.
Sovio U, Smith GCS. Comparison of estimated fetal weight percentiles near term for predicting extremes of birthweight percentile. Am J Obstet Gynecol. 2021;224(3):292.e1-19.
Boulvain M, Irion O, Dowswell T, Thornton JG. Induction of labour at or near term for suspected fetal macrosomia. Cochrane Database Syst Rev. 2016;2016(5):CD000938.
Boulvain M, Senat MV, Perrotin F, Winer N, Beucher G, Subtil D, et al. Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial. Lancet. 2015;385(9987):2600-5.
Warwick Clinical Trials Unit. Induction of labour for predicted macrosomia - the ‘Big Baby Trial’ [cited 2021 Mar 08]. Available from: https://warwick.ac.uk/fac/sci/med/research/ctu/trials/bigbaby/

Auteurs

Sophie Relph (S)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.

Matias C Vieira (MC)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.
Department of Obstetrics and Gynaecology, University of Campinas (UNICAMP), School of Medical Sciences, Campinas, Brazil.

Andrew Copas (A)

Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, London, UK.

Chivon Winsloe (C)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.
Centre for Pragmatic Global Health Trials, Institute for Global Health, University College London, London, UK.

Kirstie Coxon (K)

Faculty of Health, Social Care and Education, Kingston and St George's University, London, UK.

Alessandro Alagna (A)

The Guy's & St Thomas' Charity, London, UK.

Annette Briley (A)

Caring Futures Institute, Flinders University, Adelaide, South Australia, Australia.

Mark Johnson (M)

Department of Surgery and Cancer, Imperial College London, London, UK.

Louise Page (L)

West Middlesex University Hospital, Chelsea & Westminster Hospital NHS Foundation Trust, Isleworth, UK.

Donald Peebles (D)

UCL Institute for Women's Health, University College London, London, UK.

Andrew Shennan (A)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.

Baskaran Thilaganathan (B)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Molecular & Clinical Sciences Research Institute, St George's, University of London, London, UK.

Neil Marlow (N)

UCL Institute for Women's Health, University College London, London, UK.

Christoph Lees (C)

Department of Surgery and Cancer, Imperial College London, London, UK.

Deborah A Lawlor (DA)

Medical Research Council Integrative Epidemiology Unit at the University of Bristol, Bristol, UK.
Population Health Science, Bristol Medical School, University of Bristol, Bristol, UK.

Asma Khalil (A)

Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK.
Molecular & Clinical Sciences Research Institute, St George's, University of London, London, UK.

Jane Sandall (J)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.

Dharmintra Pasupathy (D)

Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St Thomas' Hospital, London, UK.
Reproduction and Perinatal Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

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