Diagnosis of Pulmonary Embolism in Pregnancy (DiPEP)

About this study

Pulmonary Embolism (PE) occurs when a blood clot, usually from the veins of the legs, breaks off and travels to the lungs.

Pregnant women are at increased risk of PE, and although rare, it is one of the most common causes of death in pregnancy and postpartum that affects women who would otherwise expect to have a long life expectancy in full health.

Patients who have PE that is appropriately diagnosed and treated have a low risk of adverse outcome, so accurate diagnosis can result in substantial benefits. However, it is estimated that only one in every 50 women investigated for suspected PE actually has PE.

Furthermore, the investigations used to diagnose PE carry some important risks to the woman, and could also harm the foetus. It is therefore very important that unnecessary treatment is not carried out, while also being sure that a potentially serious PE does not go unnoticed.

Clinical decision rules and blood tests are used in non-pregnant people with suspected PE to select those who need investigation, but these have not been properly tested in pregnant women.

We collected information from 181 pregnant or recently pregnant women with PE and 259 women without PE who had been investigated in hospital for a suspected PE. We also collected blood samples from 36 women with PE or deep vein thrombosis (DVT), and 247 with no PE or DVT.

We found that none of the clinical decision rules or blood tests were able to reliably determine which women had a PE. Economic analysis showed that scanning every woman with a suspected PE was more cost-effective than any selective approach to scanning.

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Publications

The DiPEP study: an observational study of the diagnostic accuracy of clinical assessment, D‐dimer and chest x‐ray for suspected pulmonary embolism in pregnancy and postpartum. BJOG 2018.
https://obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/1471-0528.15286

The DiPEP (Diagnosis of PE in Pregnancy) biomarker study: An observational cohort study augmented with additional cases to determine the diagnostic utility of biomarkers for suspected venous thromboembolism during pregnancy and puerperium. BJH 2018.
https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.15102

Diagnosis of Pulmonary Embolism in Pregnancy (DiPEP): Case-control study and decision-analysis modelling of diagnostic strategies
https://www.journalslibrary.nihr.ac.uk/programmes/hta/132101/#/

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Study staff

Name	Role	Organisation	Contact
Prof Steve Goodacre	Chief Investigator	Health Services Research University of Sheffield	s.goodacre@sheffield.ac.uk +44 (0) 114 222 0842
Prof Cindy Cooper	CTRU Director	Clinical Trials Research Unit (CTRU) University of Sheffield	c.l.cooper@sheffield.ac.uk +44 (0) 114 222 0743
Kimberley Horspool	Study Manager	Health Services Research University of Sheffield	k.horspool@sheffield.ac.uk +44 (0) 114 222 4348
Diana Papaioannou	CTRU Adviser	Clinical Trials Research Unit (CTRU) University of Sheffield	d.papaioannou@sheffield.ac.uk +44 (0) 114 222 0766
Ellen Bradley	Research Assistant	Clinical Trials Research Unit (CTRU) University of Sheffield	e.bradley@sheffield.ac.uk +44 (0) 114 222 0843
Heather Dakin	Trial Support Officer	Clinical Trials Research Unit (CTRU) University of Sheffield	h.dakin@sheffield.ac.uk +44 (0) 114 222 6385
Dr Amanda Loban	Data Manager	Clinical Trials Research Unit (CTRU) University of Sheffield	a.loban@sheffield.ac.uk +44 (0) 114 222 2995
Prof Michael Campbell	Senior Statistician	Medical Statistics Group University of Sheffield	m.j.campbell@sheffield.ac.uk
Neil Shephard	Statistician	Clinical Trials Research Unit (CTRU) University of Sheffield	n.shephard@sheffield.ac.uk +44 (0) 114 222 5203
Prof Matt Stevenson	Health Economics / Decision Modelling	Health Economics and Decision Science University of Sheffield	m.d.stevenson@sheffield.ac.uk +44 (0) 114 222 0691
Prof Marian Knight	Co-Applicant (UKOSS Lead)	University of Oxford	marian.knight@npeu.ox.ac.uk
Prof Beverley Hunt	Co-Applicant (Biomarker study lead)	Guy’s and St. Thomas’ NHS Foundation Trust	Beverley.Hunt@gstt.nhs.uk +44 (0) 207 188 2736
Prof Catherine Nelson-Piercy	Clinical Investigator (Obstetrics)	Guy’s and St. Thomas’ NHS Foundation Trust	catherine.nelson-piercy@gstt.nhs.uk +44 (0) 207 188 7905
Prof Fiona Lecky	Clinical Investigator (Emergency Medicine)	Health Services Research University of Sheffield	f.e.lecky@sheffield.ac.uk +44 (0) 114 222 4345
Dr Steven Thomas	Clinical Investigator (Radiology)	Sheffield Teaching Hospitals NHS Foundation Trust	s.m.thomas@sheffield.ac.uk +44 (0) 114 222 2993
Dr Erica Wallis	Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust	Erica.Wallis@sth.nhs.uk +44 (0) 114 226 5976

This project is funded by the National Institute for Health Research Health Technology Assessment Programme (13/21/01).

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Health Technology Assessment Programme, NIHR, NHS or the Department of Health.