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StillbirthOxGRIPNCT03662178

Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

An observational study of Stillbirth and Fetal Death, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Stillbirth, Fetal Death, Fetal Growth Retardation
How many people
56,000 participants
Where
1 siteUnited Kingdom
Study dates
1 Sep 2017to 30 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Study population: All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lawrence Impey contact

01865 851165

lawrence.impey@ouh.nhs.uk

Christina Aye contact

christina.aye@ouh.nhs.uk

United Kingdom1 site, 1 recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

    Lawrence Impey, lawrence.impey@ouh.nhs.uk

    Christina Aye, christina.aye@ouh.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read more

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.

Read the detailed description

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

Medical subject headings
Stillbirth, Fetal Death, Fetal Growth Retardation, Perinatal Death

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 yrs

Secondary outcomes (23)

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

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

    Measured: 6 yrs

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

    Number of Consultant appointments

    Measured: 6 yrs

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

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

    Measured: 6 yrs

  4. Risk Factors for adverse outcomes - ultrasound head circumference

    Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter

    Measured: 4 yrs

  5. Risk Factors for adverse outcomes - ultrasound abdomen circumference

    Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter

    Measured: 4 yrs

  6. Risk Factors for adverse outcomes - ultrasound femur length

    Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter

    Measured: 4 yrs

  7. Risk Factors for adverse outcomes - ultrasound presentation

    Fetal presentation at last scan before birth. Physiological parameter

    Measured: 4 yrs

  8. Risk Factors for adverse outcomes - Doppler ultrasound

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

    Measured: 4 yrs

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

    Diagnosis of pre eclampsia and related complications. Physiological parameter

    Measured: 4 yrs

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

    Diagnosis of Gestational Diabetes. Physiological parameter

    Measured: 4 yrs

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

    Mode of Delivery

    Measured: 4 yrs

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

    Number of preterm births by gestation per 1000 pregnancies

    Measured: 4 yrs

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

    Antenatal fetal loss rate per 1000 pregnancies

    Measured: 4 yrs

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

    Intrapartum fetal loss rate per 1000 pregnancies

    Measured: 4 yrs

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

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

    Measured: 4 yrs

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

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

    Measured: 4 yrs

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

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

    Measured: 4 yrs

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

    Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies

    Measured: 4 yrs

  19. 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)

    Measured: 4 yrs

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

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

    Measured: 4 yrs

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

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

    Measured: 4 yrs

  22. Normal ranges of antenatal ultrasound markers.

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

    Measured: 4 yrs

  23. Normal ranges of intrapartum markers.

    Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter

    Measured: 4 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start1 Sep 2017
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
56,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662178
Sponsor's protocol ID
17/SC/0374
Acronym
OxGRIP
Status last verified
Jan 2026
First submitted
16 Nov 2017
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 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.

    PubMed 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.

    PubMed 23349424

Questions about this trial

What is this clinical trial studying?

An observational study of Stillbirth and Fetal Death, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lawrence Impey (01865 851165, lawrence.impey@ouh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of OxGRIP on Perinatal mortality according to gestation (time frame: 4 yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662178, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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