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

December 13, 2023 updated by: Lawrence Impey, Oxford University Hospitals NHS Trust

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.

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.

Study Overview

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

56000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 yrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the OxGRIP Pathway on service: number of scans
Time Frame: 6 yrs
Number of Ultrasound Scans (>24 weeks gestation) performed per pregnancy
6 yrs
Impact of the OxGRIP Pathway on service - Consultant time
Time Frame: 6 yrs
Number of Consultant appointments
6 yrs
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
6 yrs
Risk Factors for adverse outcomes - ultrasound head circumference
Time Frame: 4 yrs
Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter
4 yrs
Risk Factors for adverse outcomes - ultrasound abdomen circumference
Time Frame: 4 yrs
Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter
4 yrs
Risk Factors for adverse outcomes - ultrasound femur length
Time Frame: 4 yrs
Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter
4 yrs
Risk Factors for adverse outcomes - ultrasound presentation
Time Frame: 4 yrs
Fetal presentation at last scan before birth. Physiological parameter
4 yrs
Risk Factors for adverse outcomes - Doppler ultrasound
Time Frame: 4 yrs
Uterine/umbilical artery/ middle cerebral artery Doppler values. Physiological parameter
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: hypertension
Time Frame: 4 yrs
Diagnosis of pre eclampsia and related complications. Physiological parameter
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: diabetes
Time Frame: 4 yrs
Diagnosis of Gestational Diabetes. Physiological parameter
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: mode of birth
Time Frame: 4 yrs
Mode of Delivery
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: preterm birth
Time Frame: 4 yrs
Number of preterm births by gestation per 1000 pregnancies
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: stillbirth
Time Frame: 4 yrs
Antenatal fetal loss rate per 1000 pregnancies
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: intrapartum stillbirth
Time Frame: 4 yrs
Intrapartum fetal loss rate per 1000 pregnancies
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: neonatal death
Time Frame: 4 yrs
Neonatal death <30 days of age: rate per 1000 livebirths
4 yrs
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
4 yrs
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
4 yrs
Clinical outcomes during pregnancy and postnatal/neonatal period: HIE
Time Frame: 4 yrs
Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies
4 yrs
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)
4 yrs
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)
4 yrs
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
4 yrs
Normal ranges of antenatal ultrasound markers.
Time Frame: 4 yrs
Development of normal range of routinely collected ultrasound measurements. Physiological parameter
4 yrs
Normal ranges of intrapartum markers.
Time Frame: 4 yrs
Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter
4 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lawrence Impey, FRCOG, Oxford University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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