Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

Study Overview
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Brief Summary
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Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015). Therefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing. However, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015). Oxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention. It has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting. The principles of the pathway are A universal routine scan at 36 weeks gestation. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR). The clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal / reference ranges for ultrasound values.

Detailed Description
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There is no requirement for patient participation in this study. All data collected and analysed is routinely collected clinical data.

Official Title
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Investigating the Structured Use of Ultrasound Scanning for Fetal Growth (Oxford Growth Restriction Identification Programme (OxGRIP)) on Risk Factors for and the Incidences of Adverse Maternal, Fetal and Neonatal Outcome

Conditions
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Stillbirth, Fetal Death, Fetal Growth Retardation, Small for Gestational Age, Fetal Growth Restriction, Perinatal Death, Intrauterine Growth Restriction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019 with no exclusion criteria Exclusion Criteria: Women who have opted out of research related to pregnancy in this pregnancy whilst receiving care by the OUHFT. If intrapartum care takes place outside of the OUHFT.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of OxGRIP on Perinatal mortality according to gestation | Mortality (stillbirth and neonatal death per 1000 pregnancies) in the period after birth) assessed in 2 years before the programme and compared with the 2 years after the programme started. Assessed for all pregnancies and for those reaching 35 weeks' gestation | 4 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the OxGRIP Pathway on service: number of scans | Number of Ultrasound Scans (>24 weeks gestation) performed per pregnancy | 6 yrs | 
| Impact of the OxGRIP Pathway on service - Consultant time | Number of Consultant appointments | 6 yrs | 
| Impact of the OxGRIP Pathway on service - intrapartum interventions | Proportion of all birth delivered as emergency and elective cesarean sections and instrumental deliveries | 6 yrs | 
| Risk Factors for adverse outcomes - ultrasound head circumference | Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter | 4 yrs | 
| Risk Factors for adverse outcomes - ultrasound abdomen circumference | Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter | 4 yrs | 
| Risk Factors for adverse outcomes - ultrasound femur length | Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter | 4 yrs | 
| Risk Factors for adverse outcomes - ultrasound presentation | Fetal presentation at last scan before birth. Physiological parameter | 4 yrs | 
| Risk Factors for adverse outcomes - Doppler ultrasound | Uterine/umbilical artery/ middle cerebral artery Doppler values. Physiological parameter | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension | Diagnosis of pre eclampsia and related complications. Physiological parameter | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes | Diagnosis of Gestational Diabetes. Physiological parameter | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth | Mode of Delivery | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth | Number of preterm births by gestation per 1000 pregnancies | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth | Antenatal fetal loss rate per 1000 pregnancies | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth | Intrapartum fetal loss rate per 1000 pregnancies | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death | Neonatal death <30 days of age: rate per 1000 livebirths | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: infant | Neonatal/infant death >30 days of age <1year of age: per 1000 live births | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal admission | Adverse neonatal outcome - planned/unplanned admission to NICU: rate per 1000 pregnancies | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: HIE | Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: cord gas | Cord Blood Gases outside normal range (umbilical cord arterial pH at birth <7.00 and <7.05) | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: Apgar | Apgar score at birth (continuous variable and rate of <7 at 5 mins) | 4 yrs | 
| Clinical outcomes during pregnancy and postnatal/neonatal period: size | Small for Gestational Age birthweight - by Hadlock and Intergrowth centiles. Physiological parameter | 4 yrs | 
| Normal ranges of antenatal ultrasound markers. | Development of normal range of routinely collected ultrasound measurements. Physiological parameter | 4 yrs | 
| Normal ranges of intrapartum markers. | Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter | 4 yrs |