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Clinical Trials/NCT03662178
NCT03662178
Recruiting
Not Applicable

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

Oxford University Hospitals NHS Trust1 site in 1 country56,000 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stillbirth
Sponsor
Oxford University Hospitals NHS Trust
Enrollment
56000
Locations
1
Primary Endpoint
Impact of OxGRIP on Perinatal mortality according to gestation
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
September 30, 2029
Last Updated
3 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lawrence Impey

Principal Investigator

Oxford University Hospitals NHS Trust

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.

Outcomes

Primary Outcomes

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

  • Impact of the OxGRIP Pathway on service - Consultant time(6 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth(4 yrs)
  • Normal ranges of antenatal ultrasound markers.(4 yrs)
  • Impact of the OxGRIP Pathway on service - intrapartum interventions(6 yrs)
  • Risk Factors for adverse outcomes - ultrasound femur length(4 yrs)
  • Risk Factors for adverse outcomes - ultrasound presentation(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: Apgar(4 yrs)
  • Impact of the OxGRIP Pathway on service: number of scans(6 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: infant(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal admission(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: HIE(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: cord gas(4 yrs)
  • Normal ranges of intrapartum markers.(4 yrs)
  • Risk Factors for adverse outcomes - ultrasound head circumference(4 yrs)
  • Risk Factors for adverse outcomes - ultrasound abdomen circumference(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth(4 yrs)
  • Risk Factors for adverse outcomes - Doppler ultrasound(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death(4 yrs)
  • Clinical outcomes during pregnancy and postnatal/neonatal period: size(4 yrs)

Study Sites (1)

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