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Completed

NCT Number: NCT04231591

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intrapartum cardiac complications

    Time frame: Inpatient admission for subsequent 48 hours

    Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest

  2. Postpartum cardiac complications

    Time frame: Initial 96 hours following delivery of infant(s)

    Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest

Secondary outcomes

  1. Intrapartum obstetrical complications

    Time frame: Inpatient admission for subsequent 48 hours

    Incidence of preeclampsia or gestational hypertension, incidence of placental abruption, cesarean section rate

  2. Postpartum obstetrical complications

    Time frame: Initial 96 hours following delivery of infant(s)

    Incidence of postpartum hemorrhage, incidence of venous thromboembolism

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: NT-proBNP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2020
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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