Assessment of the Risk of Hypertension and Cardiovascular Disease In Women with a History of Pregnancy Complications.

Study type
Protocol
Date of Approval
Study reference ID
16_212
Lay Summary

Over the last 10 years, the rate of hypertensive disorders in pregnancy (HDP) has been increasing. Earlier studies have shown a link between preeclampsia/eclampsia (a severe form of HDP) and risk of cardiovascular disease (CVD), and more recent studies have shown that other categories of HDPs may also be linked to later CVD. However, current tools used by physicians to predict later risk of CVD do not account for maternal complications in pregnancy and the earlier onset of CVD among women with a history of HDP compared to the general female population. Therefore, we propose to develop a CVD risk prediction tool that incorporates maternal complications of pregnancy. The study population will include all women between the ages of 15 to 45 years of age with a history of delivery. Women will be followed until an event occurs, the study end date, or withdrawal from the database. Given the increasing rates of HDP, the information from this study will be important in guiding physicians in their choice of treatment and policy makers in their recommendations for management of women with a history of HDP.

Technical Summary

Although previous studies have shown an association between HDP and later CVD, the tools currently used by clinicians to predict a women's long-term risk of CVD do not account for complications in pregnancy such as HDP. Given the increasing rates of HDP and the limitations of previous risk prediction tools, there is a need to develop risk prediction models accounting for complications of pregnancy. Using the CPRD Pregnancy Register liked to HES, we will develop risk prediction models using a cohort of women between the ages of 15-45 with a first recorded delivery from April 1st, 1999 to March 31st, 2016. Deliveries will be identified using Read codes in the CPRD and ICD-10 codes in HES. The date of cohort entry will be defined as 42 days after the delivery date. Women will be followed until an event (incident hypertension or cardiovascular disease or censoring due to end of CPRD registration, last data collection, or end of the study period, whichever occurs first. Prediction models will be developed using a Cox proportional hazards model with time since cohort entry as the time axis.

Health Outcomes to be Measured

The primary outcome of incident CVD will be defined as, cerebrovascular disease, coronary artery disease, coronary revascularization, myocardial infarction, peripheral vascular disease, transient ischemic attack, or stroke. For objectives 1, 3, 4, and 5, incident CVD will be defined using Read codes in the CPRD and ICD-10 codes in HES. For all objectives, the date of diagnosis in the database (for CPRD-defined events) or the date of hospital admission (for HES-defined events) will define the event date. The secondary outcome of newly diagnosed hypertension will be defined as a composite of a new diagnosis of hypertension or a new use of an anti-hypertensive drug (including angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, beta-blocker, calcium channel blockers, and diuretics). The date of diagnosis or prescription that first meets the event definition will define the event date. Similar to the primary outcome, Read codes will be used to identify diagnoses in the CPRD and ICD-10 codes from HES. Only outcomes that occur in the post-partum period will be considered.

Collaborators

Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Graeme Smith - Collaborator - Queen's University Belfast
Jennifer Hutcheon - Collaborator - University Of British Columbia
Kristian Filion - Collaborator - McGill University
pauline reynier - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Robert Platt - Collaborator - McGill University
Samuel Igweokpala - Collaborator - McGill University
Sonia Grandi - Collaborator - University of Toronto

Former Collaborators

Sonia Grandi - Collaborator - McGill University

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Pregnancy Register