Characterization of a genetic link between PREGnancy progesterone metabolite exposure and CARDiac repolarization: PREG-CARD Study
S
Sara Quinney
Primary Investigator
Enrolling By Invitation
18 years - 100 years
Female
Phase
N/A
1 participants needed
1 Location
Brief description of study
What is this study about?
This study will examine how the levels of sex hormones (e.g., estrogen and progesterone), and their byproducts, called metabolites, are associated with the heart rhythm during pregnancy. During pregnancy, the levels of these hormones increase significantly, sometimes up to ten to thirty times higher than before pregnancy. While we have some knowledge about how these hormones impact the electrical activities of the heart, there is still much to learn about the specific effects of their metabolites.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potentially eligible pregnant individuals will be identified from clinic patient pool or by a treating clinician and will be contacted directly by study staff via phone or at a clinic visit.
Detailed description of study
What will happen during the study?
- Participants will attend three visits during the second and third trimesters of pregnancy.
- During each visit, we will collect a blood sample and perform an EKG, which uses electrodes stuck to the chest, arms, and legs to give us a picture of the electrical activity of the heart.
- Each visit will last approximately 30 minutes.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pregnancy, Pregnant
-
Age: 18 years - 100 years
-
Gender: Female
Inclusion Criteria
• Pregnant individuals age ≥18 years.
• 18 to 22 weeks gestational age.
Exclusion Criteria
• Known or suspected fetal abnormalities.
• Family history of long QT syndrome, torsade de points, or sudden cardiac death not associated with acute myocardial infarction.
• Participant reported taking progesterone or any other hormonal therapies (prescription, nonprescription/herbal supplement).
• Use of any QT prolonging medication with known risk to induce Torsades de Pointes per www.crediblemeds.org during screening.
• Pregnant individuals age ≥18 years.
• 18 to 22 weeks gestational age.
Exclusion Criteria
• Known or suspected fetal abnormalities.
• Family history of long QT syndrome, torsade de points, or sudden cardiac death not associated with acute myocardial infarction.
• Participant reported taking progesterone or any other hormonal therapies (prescription, nonprescription/herbal supplement).
• Use of any QT prolonging medication with known risk to induce Torsades de Pointes per www.crediblemeds.org during screening.
Updated on
28 Apr 2025.
Study ID: OBGYN-IIR-PREGCARD, 18396
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