Healthy Heart Development and the Role of the Placenta: Origin, Screening, Intervention

STUDY NOW RECRUITING

Participants will receive a $50 Amazon e-gift card!

Study Purpose

One percent of babies are born with congenital heart defects (CHDs).  

These defects can have lifelong impacts on the health and wellness of children. This study aims to develop non-invasive ways of identifying pregnancies that have an increased risk of CHDs to improve pregnancy care and delivery planning.  

How is the Study Being Done?

Our blood contains fragments of genetic material/DNA, also known as cell-free DNA. When a woman is pregnant, her blood also contains cell-free DNA from the placenta. The research team at the University of Calgary have evidence to suggest that a significant number of congenital heart defects arise from problems with the placenta. The researchers hope to identify biomarkers by comparing the cell-free DNA in pregnant women at increased risk for heart defects with the cell-free DNA of pregnant women at low risk. 

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FAQs

  1. Control Group

    We are looking to recruit participants with low-risk pregnancies, i.e., normal detailed ultrasound and low risk screening results.

    Additional eligibility criteria:

    1. You have a singleton pregnancy, i.e., not twins

    2. You are over 18 years of age.

    3. You have a normal 18-23 week ultrasound scan result

                                                 OR 

                  You have a normal 12–14 week first trimester screen result

          4.     You are less than 31 weeks gestational age

     

  2. Affected Group

    Eligibility criteria: 

    1.  You have a confirmed diagnosis of a congenital heart defect in a singleton pregnancy up to 30 weeks gestational age.
    2.  Your unborn baby has been shown to be at high risk of having a congenital heart defect through prenatal ultrasound.

If you volunteer to participate in this study, the researcher will ask you for the following: 

  • Signed consent
  • Submit a blood sample of 2 tsps/8-10mL to be drawn at the Heritage Medical Research clinic located at the Foothills Campus, Cumming School of Medicine 
  • Agree to have your height and weight measured at the time of blood draw 
  • Agree to the accessing of medical records pertaining to yourself for this pregnancy as well as for your baby up to 6 months after delivery

There is no cost for participating in this study and you will not have to pay parking expenses at the time of your blood draw. 

There are no direct benefits to you personally for enrolling in this study and there will be no individual results made available to participants. The researchers hope to identify biomarkers that could be used in early pregnancy that would assist with early diagnosis of congenital heart defects which would be of benefit to anyone who becomes pregnant in the future. 

The risks associated with this study would arise from the blood draw itself (bruising, infection) or the risk that people outside the research team will see your information. Information about you will be handled as confidentially as possible, but there is always the potential for an unintended breach of privacy. Data will be stored on secure, encrypted and password protected servers at the University of Calgary and Alberta Health Services in compliance with all University of Calgary research protocols. 

Investigators

  • Dr. Myriam Hemberger, PhD 
  • Dr. Wendy Dean, PhD 
  • Dr. Francois Bernier, MD 
  • Dr. Deborah Fruitman, MD 
  • Dr. Lindsay Mills, MD 

For More Information or to Enroll

Please Contact:

Olivia Young

E-mail: Olivia.Young2@albertahealthservices.ca

Phone: 403-955-3198

E-mail

This study has been approved by the University of Calgary Conjoint Health Ethics Research Board REB23-0844