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Investigating the Structured Use of Ultrasound Scanning for Fetal Growth (OxGRIP)

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ClinicalTrials.gov Identifier: NCT03662178
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lawrence Impey, Oxford University Hospitals NHS Trust

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.


Condition or disease
Stillbirth Fetal Death Fetal Growth Retardation Small for Gestational Age Fetal Growth Restriction Perinatal Death Intrauterine Growth Restriction

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

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Study Type : Observational
Estimated Enrollment : 56000 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662178


Contacts
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Contact: Katherine Edwards +44 (0) 1865 784969 katherine.edwards@oxfordahsn.org
Contact: Lawrence Impey lawrence.impey@ouh.nhs.uk

Locations
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United Kingdom
Oxford University Hospitals NHS Foundation Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Katherine Edwards    +44 (0) 1865 784969    katherine.edwards@oxfordahsn.org   
Contact: Lawrence Impey       lawrence.impey@ouh.nhs.uk   
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
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Study Director: Lawrence Impey Oxford University Hospitals NHS Trust
Principal Investigator: Katherine Edwards Oxford University Hospitals NHS Trust

Publications:

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Responsible Party: Lawrence Impey, Principal Investigator, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03662178     History of Changes
Other Study ID Numbers: 17/SC/0374
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Growth Retardation
Stillbirth
Fetal Death
Perinatal Death
Death
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Growth Disorders