ObesityNCT04049136
NT-proBNP Levels and Obesity in Pregnancy
An observational study of Obesity and Pregnancy Complications, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pregnancy Complications, Peripartum Cardiomyopathy
- What is being tested?
- NT-proBNP
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Eligibility criteria Third-trimester pregnancy (≥27 weeks)
Exclusion criteria Age ≥ 18 years English-speaking Fetal complications
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Perinatal Durham Clinic
Durham, North Carolina, 27705
About this study
Official title: Comparison of Amino-Terminal Pro-Brain Natriuretic Peptide Levels in Healthy Obese and Non-Obese Pregnant Women
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.
Read the detailed description
This study is a prospective, cross-sectional observational study of pregnant women >= 18-years-old receiving prenatal care through the Duke University Health System. Potential study subjects will be approached by obstetric providers or by trained research staff at routine prenatal visits. Approximately 55 subjects will be enrolled, accounting for a potential 10% loss to follow-up.
Women with pre-pregnancy BMI ≥ 30 will be considered obese, while women with BMI <30 will be included in the non-obese control group. Extremely obese (BMI≥40), obese (30≤BMI<40), overweight (25≤BMI<30), and non-obese subjects (BMI<25) will be recruited in a 1:1:1:1 fashion. Subjects will not be matched.
Data collection
Once consent to participate in the study has been obtained and a patient has been deemed eligible to participate, plasma N-terminal pro-brain natriuretic peptide (collected into a PST tube), maternal weight, and systolic and diastolic blood pressure will be collected at the given timepoints:
- Third-trimester - 27-28 weeks' gestation with third-trimester lab work (CBC, HIV, glucola)
- Admission to labor and delivery (for labor, rupture of membranes, or scheduled delivery) with admission lab work
- Immediate postpartum: 24-48 hours postpartum
- Delayed postpartum (4-6 weeks' postpartum to coincide with postpartum visit)
The following additional data will be collected from the electronic medical record: maternal age, maternal height, maternal pre-pregnancy weight, maternal weight at each time point, best obstetric estimate of due date, patient-reported race/ethnicity, gravida, para, smoking status, mode of delivery, delivery date, date of hospital discharge, minimum and maximum systolic and diastolic blood pressures during labor admission, type of anesthesia used, hemoglobin and hematocrit at 3rd-trimester lab draw, admission, and immediately postpartum (if available), and blood loss at delivery. At each visit, subjects will also be questioned about symptoms and signs of heart failure, including dyspnea on exertion, orthopnea, chest pain, and lower extremity edema.
PST tubes will be collected by trained research staff at the timepoints listed above. These will then be sent to the Duke Clinical Lab for analysis, at which point the samples will be centrifuged and the plasma analyzed for NT-proBNP. NT-proBNP will be analyzed using an electrochemiluminescence immunoassay on the Roche cobas e411 analyzer.
At each study visit time point, subjects will be asked about any symptoms related to heart failire. Should they answer yes to any of the questions, the study team will notify their clinical care team.
- Conditions
- Obesity, Pregnancy Complications, Peripartum Cardiomyopathy
- Being tested
- NT-proBNP
- Medical subject headings
- Obesity, Pregnancy Complications, Peripartum Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT-proBNPDiagnostic test
Measure levels of NT-proBNP in healthy pregnancy women across BMI categories.
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women with BMI <30 | Not described Receives: Diagnostic Test: NT-proBNP | |
| Healthy pregnant women with BMI >=30 | Not described Receives: Diagnostic Test: NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
NT-proBNP
NT-proBNP levels in pregnancy across BMI categories
Measured: 27-29 weeks
NT-proBNP
NT-proBNP levels in pregnancy across BMI categories
Measured: delivery admission
NT-proBNP
NT-proBNP levels in pregnancy across BMI categories
Measured: 24-48 hours postpartum
NT-proBNP
NT-proBNP levels in pregnancy across BMI categories
Measured: 4-6 week postpartum visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad A Grotegut, MD, MBA, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049136
- Sponsor's protocol ID
- PRO00101213
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35973801
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Amino-Terminal Pro-Brain Natriuretic Peptide Levels in Healthy Obese and Non-Obese Pregnant Women
- ClinicalTrials.gov ID
- NCT04049136
- Acronym / sponsor ID
- PRO00101213
- Conditions
- Obesity, Pregnancy Complications, Peripartum Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, cross-sectional observational study of pregnant women >= 18-years-old receiving prenatal care through the Duke University Health System. Potential study subjects will be approached by obstetric providers or by trained research staff at routine prenatal visits. Approximately 55 subjects will be enrolled, accounting for a potential 10% loss to follow-up.
Women with pre-pregnancy BMI ≥ 30 will be considered obese, while women with BMI <30 will be included in the non-obese control group. Extremely obese (BMI≥40), obese (30≤BMI<40), overweight (25≤BMI<30), and non-obese subjects (BMI<25) will be recruited in a 1:1:1:1 fashion. Subjects will not be matched.
Data collection
Once consent to participate in the study has been obtained and a patient has been deemed eligible to participate, plasma N-terminal pro-brain natriuretic peptide (collected into a PST tube), maternal weight, and systolic and diastolic blood pressure will be collected at the given timepoints:
- Third-trimester - 27-28 weeks' gestation with third-trimester lab work (CBC, HIV, glucola)
- Admission to labor and delivery (for labor, rupture of membranes, or scheduled delivery) with admission lab work
- Immediate postpartum: 24-48 hours postpartum
- Delayed postpartum (4-6 weeks' postpartum to coincide with postpartum visit)
The following additional data will be collected from the electronic medical record: maternal age, maternal height, maternal pre-pregnancy weight, maternal weight at each time point, best obstetric estimate of due date, patient-reported race/ethnicity, gravida, para, smoking status, mode of delivery, delivery date, date of hospital discharge, minimum and maximum systolic and diastolic blood pressures during labor admission, type of anesthesia used, hemoglobin and hematocrit at 3rd-trimester lab draw, admission, and immediately postpartum (if available), and blood loss at delivery. At each visit, subjects will also be questioned about symptoms and signs of heart failure, including dyspnea on exertion, orthopnea, chest pain, and lower extremity edema.
PST tubes will be collected by trained research staff at the timepoints listed above. These will then be sent to the Duke Clinical Lab for analysis, at which point the samples will be centrifuged and the plasma analyzed for NT-proBNP. NT-proBNP will be analyzed using an electrochemiluminescence immunoassay on the Roche cobas e411 analyzer.
At each study visit time point, subjects will be asked about any symptoms related to heart failire. Should they answer yes to any of the questions, the study team will notify their clinical care team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women with BMI <30 | – | Diagnostic Test: NT-proBNP |
| Healthy pregnant women with BMI >=30 | – | Diagnostic Test: NT-proBNP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT-proBNPMeasure levels of NT-proBNP in healthy pregnancy women across BMI categories. | Diagnostic test | Healthy pregnant women with BMI <30, Healthy pregnant women with BMI >=30 |
Primary outcome
NT-proBNP
Time frame: 27-29 weeks
NT-proBNP levels in pregnancy across BMI categories
NT-proBNP
Time frame: delivery admission
NT-proBNP levels in pregnancy across BMI categories
NT-proBNP
Time frame: 24-48 hours postpartum
NT-proBNP levels in pregnancy across BMI categories
NT-proBNP
Time frame: 4-6 week postpartum visit
NT-proBNP levels in pregnancy across BMI categories
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 35973801Denoble 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad A Grotegut, MD, MBA principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Pregnancy Complications, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NT-proBNP (time frame: 27-29 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049136, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.