Status:
UNKNOWN
Identifying Methods for Postpartum Reduction of Vascular Events: Pilot Randomized Controlled Trial
Lead Sponsor:
University of Calgary
Conditions:
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
IMPROVE is a pilot RCT with a behavioral intervention component (CardioPrevent program). The primary objectives of this pilot study are to assess the feasibility of the implementation of a postpartum ...
Detailed Description
1. Background and Rationale Cardiovascular disease (CVD) (i.e., coronary artery disease, stroke, and peripheral arterial disease) is one of the leading causes of morbidity and mortality in Canada,...
Eligibility Criteria
Inclusion
- adult women aged 18 years or older;
- diagnosis of a HDP (i.e., preeclampsia, eclampsia or gestational hypertension);
- delivering at The Foothills Medical Centre (FMC) in Calgary, Alberta;
- ability to read, write, understand, and provide informed consent in English; and
- have telephone access.
Exclusion
- pre-existing vascular disease (coronary artery disease \[i.e., stable angina, unstable angina,
- myocardial infarction, percutaneous coronary intervention or coronary artery bypass surgery\],
- cerebrovascular disease \[i.e., ischemic stroke or transient ischemic attack\], or peripheral arterial
- disease \[i.e., known abnormal ankle-brachial indices, symptoms of intermittent claudication, or
- bypass surgery to the extremities\]);
- chronic hypertension;
- diabetes (type 1 or type 2);
- pre-pregnancy kidney disease;
- planning another pregnancy within one year;
- counselling may not be appropriate (i.e., impaired cognition);
- live more than 200 km outside the Calgary region; and
- planning to move outside the Calgary region within one year of randomization.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03302260
Start Date
September 1 2019
End Date
November 1 2019
Last Update
April 18 2019
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