NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Amino-terminal pro-B-type natiuretic peptide (NT-proBNP) is a prohormone released from cardiac ventricular myocytes in direct response to cardiac workload. Secreted in the biologically inactive form, NT-proBNP is cleaved in the circulation into BNP, which subsequently exerts both vasodilatory and diuretic effects. The principal clinical utility of serum NT-proBNP measurement has been as an adjunctive marker in the diagnosis of subclinical heart failure, with higher levels typically reflective of increasing cardiac dysfunction.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ACDH Pregnancy - Study group Pregnant women with known adult congenital heart disease. |
Diagnostic Test: 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 |
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- Intrapartum cardiac complications [Inpatient admission for subsequent 48 hours]
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
- Postpartum cardiac complications [Initial 96 hours following delivery of infant(s)]
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Secondary Outcome Measures
- Intrapartum obstetrical complications [Inpatient admission for subsequent 48 hours]
Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate
- Postpartum obstetrical complications [Initial 96 hours following delivery of infant(s)]
Incidence of postpartum hemorrhage, incidence of venous thromboembolism
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant adult women ages 18 - 50
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Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)
Exclusion Criteria:
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Non-pregnant patients
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Non-English-speaking patients
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Maternal age <18 years or >50 years
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Patients with hypertensive complications of pregnancy
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Maternal peripartum cardiomyopathy
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Multiple gestation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Carl H. Rose, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-005429