TY - GEN
T1 - Placental Growth Factor Testing to Assess and Diagnose Preeclampsia
T2 - A Stepped Wedge Randomised Controlled Trial
AU - Duhig, K.E.
AU - Myers, J.
AU - Seed, Paul T.
AU - Hunter, R.M.
AU - Shennan, A.H.
AU - Chappell, L.C.
PY - 2018
Y1 - 2018
N2 - Background Previous prospective cohort studies have demonstrated that angiogenic factor measurements have high diagnostic accuracy in women with suspected pre-eclampsia, but the clinical impact of these tests when revealed to clinicians remains uncertain. Methods We conducted a multi-centre, pragmatic, stepped-wedge cluster randomised controlled trial in eleven UK maternity units (3000-9000 deliveries per annum). Women who presented with suspected pre-eclampsia between 20 0 and 36 6 weeks' gestation were invited to participate. Maternity units were randomly assigned to the order of implementation of revealed PlGF measurement, incorporated within a clinical management algorithm; in the usual care arm, PlGF measurement remained concealed. The primary outcome was time from presentation with suspected pre-eclampsia to documented pre-eclampsia. Secondary outcomes included other maternal and perinatal adverse outcomes. Findings Between June 2016 and October 2017, 1,023 women with suspected pre-eclampsia were enrolled. Median time to preeclampsia diagnosis decreased from 4·1 days (usual care) to 1·9 days (intervention) (time ratio 0·39 (95% CI 0·17-0·91) by parametric survival analysis). Maternal severe adverse outcomes reduced from 5·4% (usual care group) to 3·8% ((intervention group) adjusted OR 0·32 (95% CI 0·11-0·96) with no evidence of a difference in perinatal adverse outcomes. Interpretation PlGF testing has been shown to substantially reduce the time to clinical confirmation of preeclampsia. Where PlGF was implemented there was a reduction in maternal adverse outcomes, consistent with targeted, enhanced surveillance as recommended in the trial management guidance for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study. Trial Registration Number: ISRCTN 16842031 Funding: This trial was supported by grants from the National Institute for Health Research, Research for Patient Benefit Programme (PB-PG-0214-33054) and National Institute for Health Research Professorship (Chappell RP-2014-05-019). Declaration of Interest: KD, LCC, PS, JM and AS have no conflicts of interest. RH has received writing fees from Alere for previous work Ethical Approval: The trial was approved by the London South East Research Ethics Committee (ref. 15/LO/2058). © 2018, The Authors. All rights reserved.
AB - Background Previous prospective cohort studies have demonstrated that angiogenic factor measurements have high diagnostic accuracy in women with suspected pre-eclampsia, but the clinical impact of these tests when revealed to clinicians remains uncertain. Methods We conducted a multi-centre, pragmatic, stepped-wedge cluster randomised controlled trial in eleven UK maternity units (3000-9000 deliveries per annum). Women who presented with suspected pre-eclampsia between 20 0 and 36 6 weeks' gestation were invited to participate. Maternity units were randomly assigned to the order of implementation of revealed PlGF measurement, incorporated within a clinical management algorithm; in the usual care arm, PlGF measurement remained concealed. The primary outcome was time from presentation with suspected pre-eclampsia to documented pre-eclampsia. Secondary outcomes included other maternal and perinatal adverse outcomes. Findings Between June 2016 and October 2017, 1,023 women with suspected pre-eclampsia were enrolled. Median time to preeclampsia diagnosis decreased from 4·1 days (usual care) to 1·9 days (intervention) (time ratio 0·39 (95% CI 0·17-0·91) by parametric survival analysis). Maternal severe adverse outcomes reduced from 5·4% (usual care group) to 3·8% ((intervention group) adjusted OR 0·32 (95% CI 0·11-0·96) with no evidence of a difference in perinatal adverse outcomes. Interpretation PlGF testing has been shown to substantially reduce the time to clinical confirmation of preeclampsia. Where PlGF was implemented there was a reduction in maternal adverse outcomes, consistent with targeted, enhanced surveillance as recommended in the trial management guidance for clinicians. Adoption of PlGF testing in women with suspected pre-eclampsia is supported by the results of this study. Trial Registration Number: ISRCTN 16842031 Funding: This trial was supported by grants from the National Institute for Health Research, Research for Patient Benefit Programme (PB-PG-0214-33054) and National Institute for Health Research Professorship (Chappell RP-2014-05-019). Declaration of Interest: KD, LCC, PS, JM and AS have no conflicts of interest. RH has received writing fees from Alere for previous work Ethical Approval: The trial was approved by the London South East Research Ethics Committee (ref. 15/LO/2058). © 2018, The Authors. All rights reserved.
UR - http://www.scopus.com/inward/record.url?eid=2-s2.0-85116837624&partnerID=MN8TOARS
U2 - 10.2139/ssrn.3242349
DO - 10.2139/ssrn.3242349
M3 - Other contribution
ER -