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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACDH Pregnancy - Study group | Pregnant women with known adult congenital heart disease. |
| |
| Uncomplicated pregnancy - Control group | Healthy women with an uncomplicated pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-proBNP | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intrapartum cardiac complications | Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest | Inpatient admission for subsequent 48 hours |
| Postpartum cardiac complications | Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest | Initial 96 hours following delivery of infant(s) |
| Measure | Description | Time Frame |
|---|---|---|
| Intrapartum obstetrical complications | Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate | Inpatient admission for subsequent 48 hours |
| Postpartum obstetrical complications |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant females
This 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. A gestational age threshold of 37 weeks will be utilized for the control group.
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| Name | Affiliation | Role |
|---|---|---|
| Carl H. Rose, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Incidence of postpartum hemorrhage, incidence of venous thromboembolism
| Initial 96 hours following delivery of infant(s) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |