Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stillbirth, Fetal Death, Fetal Growth Retardation, Small for Gestational Age. Basic parameters: 16 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 1. A universal routine scan at 36 weeks gestation. 2. 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. 3. 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
There is no requirement for patient participation in this study. All data collected and analysed is routinely collected clinical data.
Primary outcome measures
- Impact of OxGRIP on Perinatal mortality according to gestation [Time frame: 4 yrs]
Secondary outcome measures (12)
- Impact of the OxGRIP Pathway on service: number of scans [Time frame: 6 yrs]
- Impact of the OxGRIP Pathway on service - Consultant time [Time frame: 6 yrs]
- Impact of the OxGRIP Pathway on service - intrapartum interventions [Time frame: 6 yrs]
- Risk Factors for adverse outcomes - ultrasound head circumference [Time frame: 4 yrs]
- Risk Factors for adverse outcomes - ultrasound abdomen circumference [Time frame: 4 yrs]
- Risk Factors for adverse outcomes - ultrasound femur length [Time frame: 4 yrs]
- Risk Factors for adverse outcomes - ultrasound presentation [Time frame: 4 yrs]
- Risk Factors for adverse outcomes - Doppler ultrasound [Time frame: 4 yrs]
- Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension [Time frame: 4 yrs]
- Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes [Time frame: 4 yrs]
- Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth [Time frame: 4 yrs]
- Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth [Time frame: 4 yrs]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Oxford University Hospitals NHS Foundation Trust — Oxford
Publications
- Chauhan SP, Magann EF. Screening for fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):284-94. doi: 10.1097/00003081-200606000-00010. PMID 16721107
- Gardosi J, Francis A. Adverse pregnancy outcome and association with small for gestational age birthweight by customized and population-based percentiles. Am J Obstet Gynecol. 2009 Jul;201(1):28.e1-8. doi: 10.1016/j.ajog.2009.04.034. PMID 19576372
- Sovio U, White IR, Dacey A, Pasupathy D, Smith GCS. Screening for fetal growth restriction with universal third trimester ultrasonography in nulliparous women in the Pregnancy Outcome Prediction (POP) study: a prospective cohort study. Lancet. 2015 Nov 21;386(10008):2089-2097. doi: 10.1016/S0140-6736(15)00131-2. Epub 2015 Sep 7. PMID 26360240
- Stacey T, Thompson JM, Mitchell EA, Zuccollo JM, Ekeroma AJ, McCowan LM. Antenatal care, identification of suboptimal fetal growth and risk of late stillbirth: findings from the Auckland Stillbirth Study. Aust N Z J Obstet Gynaecol. 2012 Jun;52(3):242-7. doi: 10.1111/j.1479-828X.2011.01406.x. Epub 2012 Jan 25. PMID 22276935
- Papageorghiou AT, Kennedy SH, Salomon LJ, Ohuma EO, Cheikh Ismail L, Barros FC, Lambert A, Carvalho M, Jaffer YA, Bertino E, Gravett MG, Altman DG, Purwar M, Noble JA, Pang R, Victora CG, Bhutta ZA, Villar J; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for early fetal size and pregnancy dating based on ultrasound measurement of PMID 25044000
- Gardosi J, Madurasinghe V, Williams M, Malik A, Francis A. Maternal and fetal risk factors for stillbirth: population based study. BMJ. 2013 Jan 24;346:f108. doi: 10.1136/bmj.f108. PMID 23349424
Identifiers
NCT: NCT03662178 · 17/SC/0374