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临床试验/NCT03662178
NCT03662178招募中不适用

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 个研究点 分布在 1 个国家目标入组 56,000 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
56,000
试验地点
1
主要终点
Impact of OxGRIP on Perinatal mortality according to gestation

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019 with no

排除标准

  • 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.

结局指标

主要结局

Impact of OxGRIP on Perinatal mortality according to gestation

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lawrence Impey

Principal Investigator

Oxford University Hospitals NHS Trust

研究点 (1)

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