PLANES
Research type
Research Study
Full title
PLANES - Placental Growth Factor Led Management of the Small for Gestational Age Fetus: A Feasibility Study.
IRAS ID
255682
Contact name
Andrew Sharp
Contact email
Sponsor organisation
The University of Liverpool
ISRCTN Number
ISRCTN58254381
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
The PLANES study is a randomised controlled trial investigating the feasibility of using bio marker led care for pregnant women who care carrying a small for gestational age foetus. Women with a SGA fetus and a normal bio marker (sFlt-1/PlGF) ratio will have a repeat ultrasound and repeated blood test (to retest the biomarker ratio) every 2 weeks with planned delivery delayed until 40 weeks. In those women with an SGA fetus and an abnormal sFlt-1/PlGF ratio we will offer delivery from 37 weeks, or sooner if there are other concerning features on ultrasound. Women assigned to standard care will have a biomarker (sFlt-1/PlGF) ratio taken but the result will be concealed from the clinical team with their pregnancy being managed as per the local NHS hospital policy. Results from this pilot study along with health economic and qualitative elements will inform the design of a future large randomsied controlled trial powered for adverse pregnancy outcome. Women who prefer not to be randomised will still be offered the opportunity to participate by having a biomarker (sFlt-1/PlGF) test test but the result will not be used to guide management.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0857
Date of REC Opinion
20 Feb 2019
REC opinion
Further Information Favourable Opinion