Congenital Heart Disease, Pregnancy Complications
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTNT-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.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed