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PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol

INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placent...

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Autores principales: Hayes-Ryan, Deirdre, Hemming, Karla, Breathnach, Fionnaula, Cotter, Amanda, Devane, Declan, Hunter, Alyson, McAuliffe, Fionnuala M, Morrison, John J, Murphy, Deirdre J, Khashan, Ali, McElroy, Brendan, Murphy, Aileen, Dempsey, Eugene, O’Donoghue, Keelin, Kenny, Louise C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398700/
https://www.ncbi.nlm.nih.gov/pubmed/30826791
http://dx.doi.org/10.1136/bmjopen-2018-023562
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author Hayes-Ryan, Deirdre
Hemming, Karla
Breathnach, Fionnaula
Cotter, Amanda
Devane, Declan
Hunter, Alyson
McAuliffe, Fionnuala M
Morrison, John J
Murphy, Deirdre J
Khashan, Ali
McElroy, Brendan
Murphy, Aileen
Dempsey, Eugene
O’Donoghue, Keelin
Kenny, Louise C
author_facet Hayes-Ryan, Deirdre
Hemming, Karla
Breathnach, Fionnaula
Cotter, Amanda
Devane, Declan
Hunter, Alyson
McAuliffe, Fionnuala M
Morrison, John J
Murphy, Deirdre J
Khashan, Ali
McElroy, Brendan
Murphy, Aileen
Dempsey, Eugene
O’Donoghue, Keelin
Kenny, Louise C
author_sort Hayes-Ryan, Deirdre
collection PubMed
description INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies. METHODS AND ANALYSIS: This is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks’ gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care. ETHICS AND DISSEMINATION: Ethical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02881073.
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spelling pubmed-63987002019-03-20 PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol Hayes-Ryan, Deirdre Hemming, Karla Breathnach, Fionnaula Cotter, Amanda Devane, Declan Hunter, Alyson McAuliffe, Fionnuala M Morrison, John J Murphy, Deirdre J Khashan, Ali McElroy, Brendan Murphy, Aileen Dempsey, Eugene O’Donoghue, Keelin Kenny, Louise C BMJ Open Obstetrics and Gynaecology INTRODUCTION: Women presenting with suspected pre-eclampsia are currently triaged on the basis of hypertension and dipstick proteinuria. This may result in significant false positive and negative diagnoses resulting in increased morbidity or unnecessary intervention. Recent data suggest that placental growth factor testing may be a useful adjunct in the management of women presenting with preterm pre-eclampsia. The primary objective of this trial is to determine if the addition of placental growth factor testing to the current clinical assessment of women with suspected preterm pre-eclampsia, is beneficial for both mothers and babies. METHODS AND ANALYSIS: This is a multicentre, stepped wedge cluster, randomised trial aiming to recruit 4000 women presenting with symptoms suggestive of preterm pre-eclampsia between 20 and 36+6 weeks’ gestation. The intervention of an unblinded point of care test, performed at enrolment, will quantify maternal levels of circulating plasma placental growth factor. The intervention will be rolled out sequentially, based on randomisation, in the seven largest maternity units on the island of Ireland. Primary outcome is a composite outcome of maternal morbidity (derived from the modified fullPIERS model). To ensure we are not reducing maternal morbidity at the expense of earlier delivery and worse neonatal outcomes, we have established a co-primary outcome which will examine the effect of the intervention on neonatal morbidity, assessed using a composite neonatal score. Secondary analyses will examine further clinical outcomes (such as mode of delivery, antenatal detection of growth restriction and use of antihypertensive agents) as well as a health economic analysis, of incorporation of placental growth factor testing into routine care. ETHICS AND DISSEMINATION: Ethical approval has been granted from each of the seven maternity hospitals involved in the trial. The results of the trial will be presented both nationally and internationally at conference and published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02881073. BMJ Publishing Group 2019-03-01 /pmc/articles/PMC6398700/ /pubmed/30826791 http://dx.doi.org/10.1136/bmjopen-2018-023562 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Obstetrics and Gynaecology
Hayes-Ryan, Deirdre
Hemming, Karla
Breathnach, Fionnaula
Cotter, Amanda
Devane, Declan
Hunter, Alyson
McAuliffe, Fionnuala M
Morrison, John J
Murphy, Deirdre J
Khashan, Ali
McElroy, Brendan
Murphy, Aileen
Dempsey, Eugene
O’Donoghue, Keelin
Kenny, Louise C
PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title_full PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title_fullStr PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title_full_unstemmed PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title_short PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol
title_sort parrot ireland: placental growth factor in assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a stepped wedge cluster randomised control trial research study protocol
topic Obstetrics and Gynaecology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6398700/
https://www.ncbi.nlm.nih.gov/pubmed/30826791
http://dx.doi.org/10.1136/bmjopen-2018-023562
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