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The PLANES study : a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test informed care versus standard care alone for women with a small for gestational age fetus at or after 32+0 weeks’ gestation
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Gent, Joanna, Bullough, Sian, Harrold, Jane, Jackson, Richard, Woolfall, Kerry, Andronis, Lazaros, Kenny, Louise, Cornforth, Christine, Heazell , Alexander E. P., Benbow, Emily, Alfirevic, Zarko and Sharp, Andrew (2020) The PLANES study : a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test informed care versus standard care alone for women with a small for gestational age fetus at or after 32+0 weeks’ gestation. Pilot and Feasibility Studies, 6 . 179. doi:10.1186/s40814-020-00722-x
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WRAP-The-PLANES-study-protocol-randomised-controlled-feasibility-study-placental-growth-factor (PlGF)-Andronis-2020.pdf - Accepted Version Embargoed item. Restricted access to Repository staff only - Requires a PDF viewer. Download (295Kb) |
Official URL: https://doi.org/10.1186/s40814-020-00722-x
Abstract
Background: Stillbirth remains a major concern across the globe and in some high-resource countries, such as the UK, efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small for gestational age (SGA) and these pregnancies are also at risk of neonatal adverse outcomes and lifelong health problems, especially when delivered preterm. Current UK clinical guidance advocates regular monitoring and early term delivery of the SGA fetus however; the most appropriate regimen for surveillance of these babies remains unclear and often leads to increased intervention for a large number of these women. This pilot trial will determine the feasibility of a large-scale trial refining the risk of adverse pregnancy outcome in SGA pregnancies using biomarkers of placental function sFlt-1/PlGF, identifying and intervening in only those deemed at highest risk of stillbirth.
Methods: PLANES is a randomised controlled feasibility study of women with an SGA fetus that will be conducted at two tertiary care hospitals in the UK. Once identified on ultrasound, women will be randomised into two groups in a 3:1 ratio in favour of sFlt-1/PlGF ratio led management vs standard care. Women with an SGA fetus and a normal sFlt-1/PlGF ratio will have a repeat ultrasound and sFlt-1/PlGF ratio every 2 weeks with planned birth delayed until 40 weeks. In those women with an SGA fetus and an abnormal sFlt-1/PlGF ratio we will offer birth from 37 weeks, or sooner if there are other concerning features on ultrasound. Women assigned to standard care will have an sFlt-1/PlGF ratio taken but the results will be concealed from the clinical team and the woman’s pregnancy will be managed as per the local NHS hospital policy. This integrated mixed method study will also involve a health economic analysis and a perspectives work package exploring trial feasibility through interviews and questionnaires with participants, their partners and clinicians.
Discussion: Our aim is to determine feasibility through the assessment of our ability to recruit and retain participants to the study. Results from this pilot study will inform the design of a future large randomised controlled trial that will be adequately powered for adverse pregnancy outcome. Such a study would provide the evidence needed to guide future management of the SGA fetus.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RG Gynecology and obstetrics | ||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Stillbirth -- Research, Obstetrics -- Research, Clinical trials, Placenta | ||||||
| Journal or Publication Title: | Pilot and Feasibility Studies | ||||||
| Publisher: | BioMed Central Ltd. | ||||||
| ISSN: | 2055-5784 | ||||||
| Official Date: | 19 November 2020 | ||||||
| Dates: |
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| Date of first compliant deposit: | 10 November 2020 | ||||||
| Volume: | 6 | ||||||
| Article Number: | 179 | ||||||
| DOI: | 10.1186/s40814-020-00722-x | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||
| Funder: | NIHR RfPB | ||||||
| RIOXX Funder/Project Grant: |
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