NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

Conditions
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Congenital Heart Disease, Pregnancy Complications

Intervention / Treatment
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* Diagnostic Test: NT-proBNP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant adult women ages 18 - 50 Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group) Exclusion Criteria: Non-pregnant patients Non-English-speaking patients Maternal age <18 years or >50 years Patients with hypertensive complications of pregnancy Maternal peripartum cardiomyopathy Multiple gestation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACDH Pregnancy - Study group<br>Pregnant women with known adult congenital heart disease. | Diagnostic Test: NT-proBNP<br>* 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.<br>|
| Uncomplicated pregnancy - Control group<br>Healthy women with an uncomplicated pregnancy | Diagnostic Test: NT-proBNP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Incidence of postpartum hemorrhage, incidence of venous thromboembolism | Initial 96 hours following delivery of infant(s) |