- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03662178
Investigating the Structured Use of Ultrasound Scanning for Fetal Growth (OxGRIP)
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
- A universal routine scan at 36 weeks gestation.
- 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.
- 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
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lawrence Impey
- Phone Number: 01865 851165
- Email: lawrence.impey@ouh.nhs.uk
Study Contact Backup
- Name: Christina Aye
- Email: christina.aye@ouh.nhs.uk
Study Locations
-
-
Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Recruiting
- Oxford University Hospitals NHS Foundation Trust
-
Contact:
- Lawrence Impey
- Email: lawrence.impey@ouh.nhs.uk
-
Contact:
- Christina Aye
- Email: christina.aye@ouh.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Study Director: Lawrence Impey, FRCOG, Oxford University Hospitals NHS Trust
Publications and helpful links
General Publications
- 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.
- Chauhan SP, Magann EF. Screening for fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):284-94. doi: 10.1097/00003081-200606000-00010.
- 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.
- 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. Erratum In: Lancet. 2015 Nov 21;386(10008):2058.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/SC/0374
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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