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

OBJECTIVE 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. DESIGN Secondary analysis of a pragmatic open randomised cluster control trial comparing the GAP with standard care. SETTING Eleven UK maternity units. POPULATION Pregnant women and their LGA babies born at ≥36+0  weeks of gestation. METHODS 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. MAIN OUTCOME MEASURES Rate of detection of LGA (estimated fetal weight on ultrasound scan above the 90th centile after 34+0  weeks of gestation, defined by either population or customised growth charts), maternal and perinatal outcomes (e.g. mode of birth, postpartum haemorrhage, severe perineal tears, birthweight and gestational age, neonatal unit admission, perinatal mortality, and neonatal morbidity and mortality). RESULTS 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. CONCLUSIONS The use of GAP did not change the rate of antenatal ultrasound detection of LGA when compared with standard care.

[1]  Anna L. David,et al.  Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial , 2022, Implementation Science.

[2]  N. Marlow,et al.  Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial , 2022, PLoS medicine.

[3]  Walter Muruet Gutierrez,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 , 2021, Trials.

[4]  C. Mckinlay,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 , 2020, The Australian & New Zealand journal of obstetrics & gynaecology.

[5]  U. Sovio,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 , 2020, PLoS medicine.

[6]  U. Sovio,et al.  Comparison of estimated fetal weight percentiles near term for predicting extremes of birth weight percentile. , 2020, American journal of obstetrics and gynecology.

[7]  U. Sovio,et al.  Performance of different fetal growth charts in prediction of large‐for‐gestational age and associated neonatal morbidity in multiethnic obese population , 2020, Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology.

[8]  I. White,et al.  The cost‐effectiveness of universal late‐pregnancy screening for macrosomia in nulliparous women: a decision analysis , 2019, BJOG : an international journal of obstetrics and gynaecology.

[9]  D. Lawlor,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 , 2019, Trials.

[10]  R. Reynolds,et al.  Care of Women with Obesity in Pregnancy , 2018, BJOG : an international journal of obstetrics and gynaecology.

[11]  N. Fox,et al.  Accuracy of sonographic estimated fetal weight in suspected macrosomia: the likelihood of overestimating and underestimating the true birthweight , 2018, The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians.

[12]  L. Poston,et al.  Antenatal risk factors associated with neonatal morbidity in large‐for‐gestational‐age infants: an international prospective cohort study , 2018, Acta obstetricia et gynecologica Scandinavica.

[13]  K. Hemming,et al.  Analysis of cluster randomised trials with an assessment of outcome at baseline , 2018, British Medical Journal.

[14]  M. Boulvain,et al.  Induction of labour at or near term for suspected fetal macrosomia. , 2016, The Cochrane database of systematic reviews.

[15]  Y. Takwoingi,et al.  Antenatal magnetic resonance imaging versus ultrasound for predicting neonatal macrosomia: a systematic review and meta‐analysis , 2016, BJOG : an international journal of obstetrics and gynaecology.

[16]  F. Alderdice,et al.  Women's perceptions and experiences of fetal macrosomia. , 2014, Midwifery.

[17]  J. Gardosi,et al.  The Growth Assessment Protocol: a national programme to improve patient safety in maternity care , 2013 .

[18]  D. Pasupathy,et al.  Disproportionate body composition and perinatal outcome in large‐for‐gestational‐age infants to mothers with type 1 diabetes , 2012, BJOG : an international journal of obstetrics and gynaecology.

[19]  G. Piaggio,et al.  Consort 2010 statement: extension to cluster randomised trials , 2012, BMJ : British Medical Journal.

[20]  I. Meizner,et al.  Sonographic Prediction of Fetal Macrosomia , 2010 .

[21]  C. Ananth,et al.  Birth weight and fetal death in the United States: the effect of maternal diabetes during pregnancy. , 2002, American journal of obstetrics and gynecology.

[22]  F. P. Hadlock,et al.  In utero analysis of fetal growth: a sonographic weight standard. , 1991, Radiology.