NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
NCT ID: NCT04231591
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2019-11-13
2023-12-01
Brief Summary
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Detailed Description
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The proposed prospective cohort study intends to collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events. Both pregnant patients with previously-diagnosed ACHD and those diagnosed and delivering during the study interval will be candidates for participation, and a gestational age threshold of 37 weeks will be utilized for the control group.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ACDH Pregnancy - Study group
Pregnant women with known adult congenital heart disease.
NT-proBNP
Collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events.
Uncomplicated pregnancy - Control group
Healthy women with an uncomplicated pregnancy
NT-proBNP
Collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events.
Interventions
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NT-proBNP
Collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events.
Eligibility Criteria
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Inclusion Criteria
* Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)
Exclusion Criteria
* Non-English-speaking patients
* Maternal age \<18 years or \>50 years
* Patients with hypertensive complications of pregnancy
* Maternal peripartum cardiomyopathy
* Multiple gestation
18 Years
50 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Carl H. Rose
Principal Investigator
Principal Investigators
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Carl H. Rose, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-005429
Identifier Type: -
Identifier Source: org_study_id
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