Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
NCT Number: NCT03662178
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.
Interested in participating?
Request Info16 year–60 year
Female
Observational
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Location status: Recruiting
There is no requirement for patient participation in this study. All data collected and analysed is routinely collected clinical data.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 yrs
Number of Ultrasound Scans (>24 weeks gestation) performed per pregnancy
Time frame: 6 yrs
Number of Consultant appointments
Time frame: 6 yrs
Proportion of all birth delivered as emergency and elective cesarean sections and instrumental deliveries
Time frame: 4 yrs
Routinely collected ultrasound fetal measurements - Head Circumference. Physiological parameter
Time frame: 4 yrs
Routinely collected ultrasound fetal measurements - Abdominal Circumference.Physiological parameter
Time frame: 4 yrs
Routinely collected ultrasound fetal measurements - Femur Length. Physiological parameter
Time frame: 4 yrs
Fetal presentation at last scan before birth. Physiological parameter
Time frame: 4 yrs
Uterine/umbilical artery/ middle cerebral artery Doppler values. Physiological parameter
Time frame: 4 yrs
Diagnosis of pre eclampsia and related complications. Physiological parameter
Time frame: 4 yrs
Diagnosis of Gestational Diabetes. Physiological parameter
Time frame: 4 yrs
Mode of Delivery
Time frame: 4 yrs
Number of preterm births by gestation per 1000 pregnancies
Time frame: 4 yrs
Antenatal fetal loss rate per 1000 pregnancies
Time frame: 4 yrs
Intrapartum fetal loss rate per 1000 pregnancies
Time frame: 4 yrs
Neonatal death <30 days of age: rate per 1000 livebirths
Time frame: 4 yrs
Neonatal/infant death >30 days of age <1year of age: per 1000 live births
Time frame: 4 yrs
Adverse neonatal outcome - planned/unplanned admission to NICU: rate per 1000 pregnancies
Time frame: 4 yrs
Adverse neonatal outcome - diagnosis of HIE rate per 1000 pregnancies
Time frame: 4 yrs
Cord Blood Gases outside normal range (umbilical cord arterial pH at birth <7.00 and <7.05)
Time frame: 4 yrs
Apgar score at birth (continuous variable and rate of <7 at 5 mins)
Time frame: 4 yrs
Small for Gestational Age birthweight - by Hadlock and Intergrowth centiles. Physiological parameter
Time frame: 4 yrs
Development of normal range of routinely collected ultrasound measurements. Physiological parameter
Time frame: 4 yrs
Cardiotocograph results ( Dawes Redman Criteria). Physiological parameter
Contact information is provided by the study sponsor or research team.
Oxford University Hospitals NHS Trust
Other
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
Acronym: OxGRIP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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