Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

NCT03662178 | Recruiting

• 1 other identifier: 17/SC/0374
• Study Type: observational
• Target: 56,000
• Locations: 1 country
• Sites: 1

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. 1.A universal routine scan at 36 weeks gestation.
2. 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. 3.Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR).

Conditions

Stillbirth; Fetal Death; Fetal Growth Retardation; Small for Gestational Age; Fetal Growth Restriction; Perinatal Death; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• Impact of OxGRIP on Perinatal mortality according to gestation

  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 Outcomes (23)

• Impact of the OxGRIP Pathway on service: number of scans

  6 yrs

• Impact of the OxGRIP Pathway on service - Consultant time

  6 yrs

• Impact of the OxGRIP Pathway on service - intrapartum interventions

  6 yrs

• Risk Factors for adverse outcomes - ultrasound head circumference

  4 yrs

• Risk Factors for adverse outcomes - ultrasound abdomen circumference

  4 yrs

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Related Publications (6)

• Chauhan SP, Magann EF. Screening for fetal growth restriction. Clin Obstet Gynecol. 2006 Jun;49(2):284-94. doi: 10.1097/00003081-200606000-00010.

  PMID: 16721107 BACKGROUND

• 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.

  PMID: 19576372 BACKGROUND

• 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.

  PMID: 26360240 BACKGROUND

• 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.

  PMID: 22276935 BACKGROUND

• 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.

  PMID: 25044000 BACKGROUND

• 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.

  PMID: 23349424 BACKGROUND

MeSH Terms

Conditions

Stillbirth; Fetal Death; Fetal Growth Retardation; Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders

Study Officials

• Lawrence Impey, FRCOG

  Oxford University Hospitals NHS Trust

  STUDY DIRECTOR

Central Study Contacts

Lawrence Impey

CONTACT

01865 851165; lawrence.impey@ouh.nhs.uk

Christina Aye

CONTACT

christina.aye@ouh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: September 7, 2018
• Study Start: September 1, 2017
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

GB (1)