You are here

  • Home
  • Archive
  • Volume 9, Issue 2
  • 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

Article Text

Article menu

Download PDFPDF

XML
Obstetrics and gynaecology
Protocol
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
  1. Deirdre Hayes-Ryan1,2,
  2. Karla Hemming3,
  3. Fionnaula Breathnach4,
  4. Amanda Cotter5,
  5. Declan Devane6,7,
  6. Alyson Hunter8,
  7. Fionnuala M McAuliffe9,
  8. John J Morrison10,
  9. Deirdre J Murphy11,
  10. Ali Khashan12,13,
  11. Brendan McElroy14,
  12. Aileen Murphy14,
  13. Eugene Dempsey13,15,
  14. Keelin O’Donoghue2,13,
  15. Louise C Kenny13,16
  1. 1 The Irish Centre for Fetal and Neonatal Translational Research (INFANT), UCC, Cork, Ireland
  2. 2 University College Cork, Department of Obstetrics and Gynaecology, Cork, Ireland
  3. 3 Public Health, University of Birmingham, Birmingham, UK
  4. 4 Rotunda Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland
  5. 5 Department of Obstetrics and Gynaecology, Graduate Entry Medical School, University of Limerick, Limerick, Ireland
  6. 6 HRB Trials Methodology Research Network, Dublin, Ireland
  7. 7 National University of Ireland, Galway, Galway, Ireland
  8. 8 Royal Maternity Hospital, Belfast, UK
  9. 9 UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland
  10. 10 Obstetrics and Gynaecology, National University of Ireland Galway, Galway, Ireland
  11. 11 Trinity College Dublin & Coombe Women & Infants University Hospital Dublin 8, Republic of Ireland, Dublin, Ireland
  12. 12 Department of Epidemiology and Public Health, University College Cork, Cork, Ireland
  13. 13 The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland
  14. 14 Economics Department, University College Cork, Cork, Ireland
  15. 15 Department of Paediatrics and Child Health, University College Cork, Cork, Ireland
  16. 16 Department of Women’s and Children’s Health, University of Liverpool School of Life Sciences, Liverpool, UK
  1. Correspondence to Dr Deirdre Hayes-Ryan; deirdre.hayesryan{at}ucc.ie

Abstract

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.

  • pre-eclampsia
  • placental growth factor
  • stepped wedge cluster randomised trial
  • point of care diagnostic test

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/.

http://dx.doi.org/10.1136/bmjopen-2018-023562

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors All authors contributed to the overall study design and specific methodologies. LK conceived and designed the study with DD. LK and DHR produced the detailed protocol, with input from all authors. DHR drafted the manuscript with assistance from KH, KOD and LK. All authors have critically read, contributed with inputs and revisions and approved the final manuscript.

    • Funding The PARROT Ireland trial is funded by the Health Research Board Mother and Baby Clinical Trial Network Ireland (HRB CTN-2014-010). The trial is sponsored by University College Cork, Ireland. Neither the funders nor trial sponsor had a role in the design of the study and will not have any role in analyses, interpretation of the data or decision to submit results.

    • Competing interests None declared.

    • Ethics approval 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.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Not required.