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NCT Number: NCT03662178

Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

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.

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Key information

Age range

16 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Christina Aye

CONTACT

[email protected]

Lawrence Impey

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Impact of OxGRIP on Perinatal mortality according to gestation

    Time frame: 4 yrs

    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

Secondary outcomes

  1. Impact of the OxGRIP Pathway on service: number of scans

    Time frame: 6 yrs

    Number of Ultrasound Scans (>24 weeks gestation) performed per pregnancy

  2. Impact of the OxGRIP Pathway on service - Consultant time

    Time frame: 6 yrs

    Number of Consultant appointments

  3. Impact of the OxGRIP Pathway on service - intrapartum interventions

    Time frame: 6 yrs

    Proportion of all birth delivered as emergency and elective cesarean sections and instrumental deliveries

  4. Risk Factors for adverse outcomes - ultrasound head circumference

    Time frame: 4 yrs

    Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter

  5. Risk Factors for adverse outcomes - ultrasound abdomen circumference

    Time frame: 4 yrs

    Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter

  6. Risk Factors for adverse outcomes - ultrasound femur length

    Time frame: 4 yrs

    Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter

  7. Risk Factors for adverse outcomes - ultrasound presentation

    Time frame: 4 yrs

    Fetal presentation at last scan before birth. Physiological parameter

  8. Risk Factors for adverse outcomes - Doppler ultrasound

    Time frame: 4 yrs

    Uterine/umbilical artery/ middle cerebral artery Doppler values. Physiological parameter

  9. Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension

    Time frame: 4 yrs

    Diagnosis of pre eclampsia and related complications. Physiological parameter

  10. Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes

    Time frame: 4 yrs

    Diagnosis of Gestational Diabetes. Physiological parameter

  11. Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth

    Time frame: 4 yrs

    Mode of Delivery

  12. Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth

    Time frame: 4 yrs

    Number of preterm births by gestation per 1000 pregnancies

  13. Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth

    Time frame: 4 yrs

    Antenatal fetal loss rate per 1000 pregnancies

  14. Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth

    Time frame: 4 yrs

    Intrapartum fetal loss rate per 1000 pregnancies

  15. Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death

    Time frame: 4 yrs

    Neonatal death <30 days of age: rate per 1000 livebirths

  16. Clinical outcomes during pregnancy and postnatal/neonatal period: infant

    Time frame: 4 yrs

    Neonatal/infant death >30 days of age <1year of age: per 1000 live births

  17. Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal admission

    Time frame: 4 yrs

    Adverse neonatal outcome - planned/unplanned admission to NICU: rate per 1000 pregnancies

  18. Clinical outcomes during pregnancy and postnatal/neonatal period: HIE

    Time frame: 4 yrs

    Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies

  19. Clinical outcomes during pregnancy and postnatal/neonatal period: cord gas

    Time frame: 4 yrs

    Cord Blood Gases outside normal range (umbilical cord arterial pH at birth <7.00 and <7.05)

  20. Clinical outcomes during pregnancy and postnatal/neonatal period: Apgar

    Time frame: 4 yrs

    Apgar score at birth (continuous variable and rate of <7 at 5 mins)

  21. Clinical outcomes during pregnancy and postnatal/neonatal period: size

    Time frame: 4 yrs

    Small for Gestational Age birthweight - by Hadlock and Intergrowth centiles. Physiological parameter

  22. Normal ranges of antenatal ultrasound markers.

    Time frame: 4 yrs

    Development of normal range of routinely collected ultrasound measurements. Physiological parameter

  23. Normal ranges of intrapartum markers.

    Time frame: 4 yrs

    Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Aye

CONTACT

[email protected]

Lawrence Impey

CONTACT

[email protected]

01865 851165

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study 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

Acronym: OxGRIP

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Sep 7, 2018
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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