Determining the Risk Elevation After Maternity (DREAM)

Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with preeclampsia in pregnancy.

Study Overview

• Status: Unknown
• Conditions: Preeclampsia
• Intervention / Treatment: Other: Observational

Detailed Description

Preeclampsia is a complication of pregnancy that happens in about 5-7% of all births. It is diagnosed when a mother has high blood pressure in pregnancy combined with protein in the urine which is sign that the kidneys are not functioning properly. When a mother has preeclampsia, the placenta makes abnormal amounts of several important proteins that damage the lining of the mother's blood vessels. The blood vessel damage that occurs places women at up to 10 times higher risk of having a heart attack or stroke at a younger age than women who did not have preeclampsia. It usually takes between 8 and 15 years after preeclampsia is diagnosed for the first heart attack or stroke to occur.

Unfortunately, this blood vessel damage is usually silent, meaning that women and their doctors are not aware of it. This makes it hard to predict which women are at highest risk of a heart attack or stroke and therefore need extra medical care to prevent it. Abnormal levels of the placenta proteins in the blood (right after delivery and at three and six months after delivery) as well as abnormalities of the placenta itself may be the earliest way to predict which women with preeclampsia are at risk of premature heart disease or stroke.

The purpose of this study is to collect blood and placentas from women with preeclampsia and without preeclampsia to measure and compare the levels of proteins in the blood and find abnormalities of the placentas that are associated with preeclampsia. We will then see if these tests can predict which women will go on to develop high blood pressure and ultimately be at higher risk of premature heart attack or stroke after pregnancy.

• Study Type: Observational
• Enrollment (Anticipated): 55

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital, General Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

We plan to enroll 40 participants in the study: 30 women who have been diagnosed with preeclampsia and 10 women who have had a normal pregnancy.

Description

Inclusion Criteria:

Women with a pregnancy complicated by pre-eclampsia and women who are healthy and have had a normal singleton pregnancy(controls)

Exclusion Criteria:

Women with any of the following conditions will be excluded in both the control & preeclampsia groups:

1. known kidney disease prior to pregnancy or laboratory evidence of proteinuria prior to pregnancy
2. diabetes (Type I, Type II or Gestational Diabetes)
3. known Cardiovascular Disease (myocardial infarction, angina, stroke, or transient ischemic attack
4. multiple pregnancies (twins or more)
5. who do not understand English or French will be excluded In addition to those listed above, for the control group, women must have no other major maternal pregnancy complications.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preeclampsia- observational; 45 women with preeclampsia	Other: Observational
No preeclampsia- observational; 10 women without preeclampsia	Other: Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Persistence of high blood pressure (hypertension) and cardiovascular biomarkers in the blood at 6 months after a pregnancy with preeclampsia	Six months after delivery

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: The Ottawa Hospital Academic Medical Association
• Investigators: Principal Investigator: Dr Laura Gaudet, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 28, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 20140799-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED