DiPEP: Diagnosis of Pulmonary Embolism (PE) in Pregnancy
Research type
Research Study
Full title
DiPEP: Diagnosis of Pulmonary Embolism (PE) in Pregnancy
IRAS ID
156915
Contact name
Steve Goodacre
Contact email
Sponsor organisation
Sheffield Teaching Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
ISRCTN21245595, ISRCTN
Research summary
Pulmonary embolism (PE) occurs when a blood clot travels to the lungs and causes shortness of breath, chest pain, fainting and in extreme cases death. Pregnant women are at increased risk of PE and PE is one of the commonest causes of death in pregnancy. However, chest pain and shortness of breath are common in pregnancy and are not usually due to serious causes. Currently most women with suspected PE have a scan but scans carry risks and only about 1 in 50 women having a scan will actually have PE. Clinical prediction 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 therefore plan to develop and evaluate clinical predictors and blood tests for PE in pregnant women.
We plan to collect anonymous data from 150 women who are diagnosed with PE in pregnancy across all UK hospitals using the UK Obstetric Surveillance System (UKOSS)and from 250 pregnant women attending 8-20 selected hospitals with suspected PE (of whom 245 will not have PE). We will identify which patient characteristics predict whether a woman actually has a PE or not. We will test whether existing clinical prediction rules can identify PE in pregnancy and whether a new or improved rule works better in pregnancy. We will also collect blood samples from the 250 pregnant women with suspected PE and 20 pregnant women diagnosed at the same 8-20 hospitals with deep vein thrombosis to determine whether blood tests can accurately identify clots. Finally, we will develop a mathematical model to simulate the management of pregnant women with suspected PE and compare the costs and benefits of different testing strategies.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1695
Date of REC Opinion
10 Oct 2014
REC opinion
Favourable Opinion