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NCT04049136 · ClinicalTrials.gov registry record
NT-proBNP Levels and Obesity in Pregnancy
A clinical trial of Obesity and Pregnancy Complications, sponsored by Duke University.
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT04049136 is a study of Obesity and Pregnancy Complications that has completed, run by Duke University. The registered enrollment target is 56 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04049136, a study of Obesity and Pregnancy Complications, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST NT-proBNP
Study Locations (1)
North Carolina
- Duke Perinatal Durham Clinic - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2020-07-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04049136
The ClinicalTrials.gov registry entry for NCT04049136 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which NT-proBNP is the first listed.
NCT04049136 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04049136 about?
NCT04049136 is a clinical study titled "NT-proBNP Levels and Obesity in Pregnancy". 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 ...
What is the current status of trial NCT04049136?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2019-07-15. Estimated completion is 2020-07-01.
What conditions does trial NCT04049136 study?
This clinical trial studies the following conditions: Obesity, Pregnancy Complications, Peripartum Cardiomyopathy.
What interventions are being tested in trial NCT04049136?
The interventions under investigation include: NT-proBNP (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04049136?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04049136 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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