Clinical trial NCT03662178: Investigating the Structured Use of Ultrasound Scanning for Fetal Growth
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stillbirth
Fetal Death
Fetal Growth Retardation
Small for Gestational Age
Fetal Growth Restriction
Perinatal Death
Intrauterine Growth Restriction
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 56000
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019

Brief summary: 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.

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.

Primary outcomes:
measure: Impact of OxGRIP on Perinatal mortality according to gestation
timeFrame: 4 yrs
Secondary outcomes:
measure: Impact of the OxGRIP Pathway on service: number of scans
timeFrame: 6 yrs
measure: Impact of the OxGRIP Pathway on service - Consultant time
timeFrame: 6 yrs
measure: Impact of the OxGRIP Pathway on service - intrapartum interventions
timeFrame: 6 yrs
measure: Risk Factors for adverse outcomes - ultrasound head circumference
timeFrame: 4 yrs
measure: Risk Factors for adverse outcomes - ultrasound abdomen circumference
timeFrame: 4 yrs
measure: Risk Factors for adverse outcomes - ultrasound femur length
timeFrame: 4 yrs
measure: Risk Factors for adverse outcomes - ultrasound presentation
timeFrame: 4 yrs
measure: Risk Factors for adverse outcomes - Doppler ultrasound
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: infant
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal admission
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: HIE
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: cord gas
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: Apgar
timeFrame: 4 yrs
measure: Clinical outcomes during pregnancy and postnatal/neonatal period: size
timeFrame: 4 yrs
measure: Normal ranges of antenatal ultrasound markers.
timeFrame: 4 yrs
measure: Normal ranges of intrapartum markers.
timeFrame: 4 yrs
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Lawrence Impey, FRCOG
role: STUDY_DIRECTOR
References:
citation: Chauhan SP, Magann EF. Screening for fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):284-94. doi: 10.1097/00003081-200606000-00010.
citation: 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.
citation: 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.
citation: 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.
citation: 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 crown-rump length in the first trimester of pregnancy. Ultrasound Obstet Gynecol. 2014 Dec;44(6):641-8. doi: 10.1002/uog.13448. Epub 2014 Nov 2.
citation: 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.