Development and validation of prediction models for risk of adverse outcomes in women with early-onset pre-eclampsia: protocol of the prospective cohort PREP study

John Allotey; Nadine Marlin; Ben W Mol; Peter Von Dadelszen; Wessel Ganzevoort; Joost Akkermans; Asif Ahmed; Jane Daniels; Jon Deeks; Khaled Ismail; Ann Marie Barnard; Julie Dodds; Sally Kerry; Carl Moons; Khalid S Khan; Richard D Riley; Shakila Thangaratinam

doi:10.1186/s41512-016-0004-8

Development and validation of prediction models for risk of adverse outcomes in women with early-onset pre-eclampsia: protocol of the prospective cohort PREP study

Diagn Progn Res. 2017 Feb 20:1:6. doi: 10.1186/s41512-016-0004-8. eCollection 2017.

Authors

John Allotey^{1

2

3}, Nadine Marlin², Ben W Mol⁴, Peter Von Dadelszen⁵, Wessel Ganzevoort⁶, Joost Akkermans⁷, Asif Ahmed⁸, Jane Daniels⁹, Jon Deeks¹⁰, Khaled Ismail¹¹, Ann Marie Barnard¹², Julie Dodds^{1

2

3}, Sally Kerry², Carl Moons¹³, Khalid S Khan^{1

2

3}, Richard D Riley¹⁴, Shakila Thangaratinam^{1

2

3}

Affiliations

¹ 1Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
² 2Pragmatic Clinical Trials Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
³ 3Multidisciplinary Evidence Synthesis Hub (MESH), Queen Mary University of London, London, UK.
⁴ 4The Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
⁵ 5Institute of Cardiovascular and Cell Sciences, St George's, University of London, London, UK.
⁶ 6Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands.
⁷ 7Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.
⁸ 8Aston Medical School, Aston University, Birmingham, UK.
⁹ 9University of Birmingham Clinical Trials Unit, Edgbaston, Birmingham, UK.
¹⁰ 10School of Health and Population Sciences, University of Birmingham, Birmingham, UK.
¹¹ 11Birmingham Centre for Women's and Children's Health, University of Birmingham, Birmingham, UK.
¹² Action on Pre-eclampsia (APEC) Charity, Evesham, Worcestershire UK.
¹³ 13Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands.
¹⁴ 14Research Institute of Primary Care and Health Sciences, Keele University, Keele, UK.

Abstract

Background: Early-onset pre-eclampsia with raised blood pressure and protein in the urine before 34 weeks' gestation is one of the leading causes of maternal deaths in the UK. The benefits to the child from prolonging the pregnancy need to be balanced against the risk of maternal deterioration. Accurate prediction models of risks are needed to plan management.

Methods: We aim to undertake a multicentre prospective cohort study (Prediction of Risks in Early onset Pre-eclampsia (PREP)) to develop clinical prediction models in women with early-onset pre-eclampsia, for risk of adverse maternal outcomes by 48 h and by discharge. We will externally validate the models in two independent cohorts with 634 and 216 women. In the secondary analyses, we will assess risk of adverse fetal and neonatal outcomes at birth and by discharge.

Discussion: The PREP study will quantify the risk of maternal complications at various time points and provide individualised estimates of overall risk in women with early-onset pre-eclampsia to plan the management.

Trial registration: ISRCTN registry, ISRCTN40384046.

Keywords: Complication risk; Early-onset pre-eclampsia; Fetal; Maternal; Prediction model; Prognosis.

Grants and funding

09/22/163/DH_/Department of Health/United Kingdom