Pregnancy Related Clinical Trial
Official title:
The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy
A prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (CTPA) protocol for suspected pulmonary embolism in pregnancy
The OPTICA study is the first prospective study of a low-dose CTPA protocol for the pregnant
population. It will define the achievable dose, image quality and safety of this protocol and
provide an evidence base upon which modern CTPA protocols can be appropriately compared to
scintigraphy for this population.
Pregnant women undergoing the specified low-dose CTPA protocol for suspected pulmonary
embolism (PE), agreed across study sites with equivalent computed-tomography (CT)
capabilities, will be included. Independent review of CTPAs by two radiology consultants,
image data analysis and 3-month patient follow up will be performed.
The diagnostic algorithm employs chest-x-ray and lower limb Doppler if lower limb symptoms
are present, followed by CTPA in cases where advanced imaging is required. D-dimer is
permitted within the diagnostic algorithm for patients recruited after implementation of the
updated 2019 "European Society of Cardiology guidelines for diagnosis and management of acute
pulmonary embolism".
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