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.

Improving antenatal detection of small-for-gestational-age fetus: economic evaluation of Growth Assessment Protocol.

OBJECTIVE: To determine whether the Growth Assessment Protocol (GAP), as implemented in the DESiGN trial, is cost-effective in terms of antenatal detection of small-for-gestational-age (SGA) neonate, when compared with standard care. METHODS: This was an incremental cost-effectiveness analysis undertaken from the perspective of a UK National Health Service hospital provider. Thirteen maternity units from England, UK, were recruited to the DESiGN (DEtection of Small for GestatioNal age fetus) trial, a cluster randomized controlled trial. Singleton, non-anomalous pregnancies which delivered after 24 + 0 gestational weeks between November 2015 and February 2019 were analyzed. Probabilistic decision modeling using clinical trial data was undertaken. The main outcomes of the study were the expected incremental cost, the additional number of SGA neonates identified antenatally and the incremental cost-effectiveness ratio (ICER) (cost per additional SGA neonate identified) of implementing GAP. Secondary analysis focused on the ICER per infant quality-adjusted life year (QALY) gained. RESULTS: The expected incremental cost (including hospital care and implementation costs) of GAP over standard care was £34 559 per 1000 births, with a 68% probability that implementation of GAP would be associated with increased costs to sustain program delivery. GAP identified an additional 1.77 SGA neonates per 1000 births (55% probability of it being more clinically effective). The ICER for GAP was £19 525 per additional SGA neonate identified, with a 44% probability that GAP would both increase cost and identify more SGA neonates compared with standard care. The probability of GAP being the dominant clinical strategy was low (11%). The expected incremental cost per infant QALY gained ranged from £68 242 to £545 940, depending on assumptions regarding the QALY value of detection of SGA. CONCLUSION: The economic case for replacing standard care with GAP is weak based on the analysis reported in our study. However, this conclusion should be viewed taking into account that cost-effectiveness analyses are always limited by the assumptions made. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Impact of introduction of the growth assessment protocol in a South Indian tertiary hospital on SGA detection, stillbirth rate and neonatal outcome.

OBJECTIVES: India has a high rate of stillbirths, and many deaths are due to fetal growth restriction and potentially preventable. Screening and identification of the small for gestational age (SGA) fetus during the antenatal period has been shown to reduce stillbirths. We set out to evaluate the impact of implementing the Growth Assessment Protocol (GAP), a programme designed for screening for SGA. METHODS: Observational study comparing two-time epochs; before (years 2011-2014) and after (years 2015-2018) introduction of GAP. The programme includes identification of risk factors, risk categorization, serial fundal height measurement, customised fetal growth charts and appropriate referral protocols. Fetal growth charts and birth centiles were generated based on the hospital database of normal outcome pregnancies, customised to women's ethnicity, parity, height, and weight. The protocol was introduced following training of obstetric and midwifery care providers. We evaluated SGA detection rates, stillbirth rates (from 28 weeks) and neonatal morbidity at term. RESULTS: There were 26,199 and 31,498 births, with 115 and 108 stillbirths in the pre and post-GAP implementation periods, respectively. SGA detection rates increased from 51.1 to 67.1%, representing a 31% improvement (p<0.001). Overall stillbirth rates declined from 4.4 to 3.4 per 1000 births (RR 0.78 CI 95% 0.60-1.02) and at term from 1.5 to 0.6 (RR 0.37 CI 95% 0.20-0.66). Neonatal intensive care admission and neonatal encephalopathy in term neonates also decreased significantly. CONCLUSIONS: Introduction of the GAP programme in an Indian tertiary maternity service was associated with improved antenatal detection of SGA and reduced stillbirth rates and neonatal morbidity.

Evaluating the Growth Assessment Protocol for stillbirth prevention: progress and challenges.

Many stillbirths are associated with fetal growth restriction, and are hence potentially avoidable. The Growth Assessment Protocol (GAP) is a multidisciplinary program with an evidence based care pathway, training in risk assessment, fetal growth surveillance with customised charts and rolling audit. Antenatal detection of small for gestational age (SGA) has become an indicator of quality of care. Evaluation is essential to understand the impact of such a prevention program. Randomised trials will not be effective if they cannot ensure proper implementation before assessment. Observational studies have allowed realistic evaluation in practice, with other factors excluded that may have influenced the outcome. An award winning 10 year study of stillbirth data in England has been able to assess the effect of GAP in isolation, and found a strong, causal association with improved antenatal detection of SGA babies, and the sustained decline in national stillbirth rates. The challenge now is to apply this program more widely in low and middle income settings where the main global burden of stillbirth is, and to adapt it to local needs and resources.

Reduction of stillbirths in England from 2008 to 2017 according to uptake of the Growth Assessment Protocol: 10-year population-based cohort study.

OBJECTIVE: Antenatal detection of small-for-gestational age (SGA) can reduce significantly the risk of stillbirth. The Growth Assessment Protocol (GAP) was developed to address the problem that most SGA fetuses are missed antenatally. We set out to analyze the effect that the GAP program has had on stillbirth rates in England. METHODS: We analyzed data from 2008 (the year before roll-out of the GAP program) to 2017 (latest available Office for National Statistics (ONS) unit-based data). The program consists of five elements: training, evidence-based guidelines for risk assessment and surveillance of fetal growth, customized charts, recording of process and outcome indicators, and audit of missed SGA cases. All maternity units in England were categorized into one of three groups according to their GAP status in 2017: (1) not in the GAP program; (2) GAP implemented partially (incomplete adoption of protocol, no monitoring and audit); and (3) GAP implemented completely. A subset of the complete-implementation group comprised the 20 units with the highest SGA detection rates. Unit-level live-birth and stillbirth data were obtained from the ONS for each of these groups. RESULTS: Stillbirth rates declined across all groups from 2008 to 2017, and significantly more in units in which GAP was implemented completely than in the non-GAP units (P < 0.05). The steepest decline in stillbirth rate was observed in the 20 units with the highest SGA detection rates, which had a 24% lower stillbirth rate compared with the units not using GAP (P < 0.01) in 2017. This difference remained significant after mixed-effects logistic regression analysis of potential confounding, including social deprivation (odds ratio, 0.76 (95% CI, 0.64-0.90)). Assessment of the nine Bradford Hill causality criteria and associated characteristics suggested that the association between implementation of the GAP program and reduction in stillbirth rate was causal. CONCLUSIONS: There has been an overall reduction in stillbirth rates in England that is likely to be a result of increased awareness of the importance of antenatal detection of SGA as a key risk factor for stillbirth. The decline in stillbirth rates was significantly greater in maternity units that had fully implemented the GAP program, and was most pronounced in the units with the highest antenatal SGA detection rates. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

UK stillbirth trends in over 11 million births provide no evidence to support effectiveness of Growth Assessment Protocol program.

OBJECTIVE: Use of the Growth Assessment Protocol (GAP) has increased internationally under the assumption that it reduces the stillbirth rate. The evidence for this is limited and based largely on an ecological time-trend study. Discordance in the uptake of the GAP program between Scotland and England/Wales enabled us to assess the assertion that implementation of GAP leads to a reduced stillbirth rate. METHODS: We analyzed data from the National Records for Scotland and the Office for National Statistics on the number of singleton maternities and stillbirths in Scotland and in England and Wales, respectively, from 1 January 2000 to 31 December 2015. National uptake of the GAP program over time in each of the regions was recorded. Stillbirth rate per 1000 maternities was calculated, according to year of delivery, and compared between Scotland and England/Wales. RESULTS: During the study period, there were 870 632 singleton maternities in Scotland, of which 4243 were stillbirths, and there were 10 469 120 singleton maternities in England and Wales, of which 51 562 were stillbirths. There was a marked difference in uptake of the GAP program between the two regions, with substantially fewer maternity units in Scotland implementing the program. Stillbirth rates were static up to 2010, with a decline thereafter in both regions, to 3.75 (95% CI, 3.25-4.30) per 1000 maternities in Scotland and 4.30 (95% CI, 4.15-4.46) per 1000 maternities in England and Wales in 2015. From 2010 onwards, the decline in Scotland was faster, equating to 48 (95% CI, 47.9-48.1) fewer stillbirths per 100 000 maternities in Scotland than in England and Wales from 2010 to 2015 compared with 2000 to 2009. CONCLUSIONS: We observed a decline in stillbirth rate in England and Wales, which coincided with implementation of the GAP program. However, a concurrent decline in stillbirth rate was observed in Scotland in the absence of increased implementation of GAP. The secular rates of change in stillbirth rate in England and Wales cannot be used to infer efficacy of the GAP program. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

Student midwives' perception of the growth assessment protocol (GAP): Preparation for clinical practice.

Fetal growth restriction is a major complication of pregnancy and increases the risk of stillbirth. Midwives screen for fetal wellbeing by measuring the symphysis fundal height to detect growth restriction, which can present in a low risk pregnancy or occur late in gestational age. The detection, surveillance and onward referral of these pregnancies are the responsibility of all midwives. To prevent avoidable stillbirth due to restricted fetal growth and to ensure safe, evidence based practice, the Perinatal Institute developed the Growth Assessment Protocol (GAP). A qualitative study using semi-structured interviews was conducted to explore 2nd year student midwives' perception of the GAP training and its impact on their clinical practice. Data was analysed and four main themes were identified using interpretative phenomenological analysis. The findings from the study show that the participants viewed the GAP training as 'authentic' and commented on the alignment with contemporary practice for the detection and surveillance of at risk pregnancies. The findings suggest that GAP training for pre-registration student midwives has the potential to provide a sustainable workforce, prepared to meet the World Health Organisation's global strategy for eliminating avoidable stillbirth by 2030.