NCT04049136

Brief Summary

A screening modality to help categorize obese pregnant women as high or low probability for heart failure would be helpful in the evaluation of the obese pregnant women with dyspnea. Outside of pregnancy, measurement of brain natriuretic peptide (BNP) or amino-terminal pro-brain natriuretic peptide (NT-proBNP) is recommended in the evaluation of acute dyspnea and in the diagnosis of heart failure. During pregnancy, elevated BNP has been associated with adverse cardiovascular events, while normal BNP levels have been observed in healthy pregnancies. While BNP levels outside of pregnancy have been shown to be lower in obese patients variations in BNP levels by body mass index (BMI) in pregnancy have not been studied. Before BNP can be deemed a reliable screening test for heart failure in obese pregnant women, normal BNP values in the setting of obesity and pregnancy need to be established. We therefore propose the following specific aims: Objective 1: Compare mean plasma NT-proBNP levels in the third trimester, immediately postpartum, and at 4-6 weeks postpartum between obese pregnant women without cardiovascular disease and non-obese pregnant women without cardiovascular disease. We hypothesize that mean plasma NT-proBNP levels in obese pregnant women without pre-existing cardiovascular disease will be significantly lower than levels in non-obese pregnant women. Objective 2: Assess whether plasma NT-proBNP levels in pregnancy correlate with BMI. We hypothesize that there will be an inverse correlation between plasma NT-proBNP levels and BMI in our pregnant cohort similar to that seen outside of pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

August 6, 2019

Last Update Submit

August 3, 2020

Conditions

ObesityPregnancy ComplicationsPeripartum Cardiomyopathy

Outcome Measures

Primary Outcomes (4)

  • NT-proBNP

    NT-proBNP levels in pregnancy across BMI categories

    27-29 weeks

  • NT-proBNP

    NT-proBNP levels in pregnancy across BMI categories

    delivery admission

  • NT-proBNP

    NT-proBNP levels in pregnancy across BMI categories

    24-48 hours postpartum

  • NT-proBNP

    NT-proBNP levels in pregnancy across BMI categories

    4-6 week postpartum visit

Study Arms (2)

Healthy pregnant women with BMI <30

Diagnostic Test: NT-proBNP

Healthy pregnant women with BMI >=30

Diagnostic Test: NT-proBNP

Interventions

NT-proBNPDIAGNOSTIC_TEST

Measure levels of NT-proBNP in healthy pregnancy women across BMI categories.

Healthy pregnant women with BMI <30Healthy pregnant women with BMI >=30

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is a prospective, cross-sectional observational study of pregnant women \>= 18-years-old receiving prenatal care through the Duke University Health System.

You may not qualify if:

  • Fetal anomalies
  • Intrauterine fetal demise
  • Fetal growth restriction (\<5%ile)
  • Fetal aneuploidy Maternal complications
  • Chronic hypertension (diagnosis pre-dating pregnancy or BP ≥140/90 at \<20 weeks gestation)
  • Autoimmune disorders (systemic lupus erythematosus, rheumatoid arthritis, Sjogren's)
  • Baseline renal disease (baseline Cr \>1.0)
  • Pre-existing diabetes mellitus
  • History of cardiomyopathy or heart failure
  • History of cardiac arrest or myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Perinatal Durham Clinic

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Denoble AE, Moyett JM, Goldstein SA, Ward CC, Truong T, Erkanli A, James AH, Grotegut CA. Prospective Observational Study of N-terminal Pro-Brain Natriuretic Peptide Levels in Obese and Nonobese Women during Pregnancy. Am J Perinatol. 2023 Apr;40(5):467-474. doi: 10.1055/a-1925-1532. Epub 2022 Aug 16.

    PMID: 35973801DERIVED

MeSH Terms

Conditions

ObesityPregnancy ComplicationsPeripartum Cardiomyopathy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy Complications, CardiovascularCardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Chad A Grotegut, MD, MBA

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

July 15, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

August 5, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)