PreeclampsiaNCT00533871
Study to Determine if Serum BNP Levels Are Elevated in Pregnant Women With Pre-Eclampsia
An observational study of Preeclampsia, run by Ohio State University at 1 site in United States.
Trial summary
Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming pregnant.B-type (also known as brain)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jun 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women age 18 or older at 34 or more weeks of pregnancy
- Control arm:normal blood pressure during pregnancy
- Chronic HTN arm: known to have HTN predating this gestation
- Pre-eclampsia arm:meet ACOG diagnostic criteria for pre-eclampsia this pregnancy and present to labor and delivery for evaluation and/ or treatment
Who cannot join
- minors, prisoners,unable to provide consent
- multiple gestation
- currently in labor
- Control arm:presence of hypertension, a history of gestational hypertension, current therapy with an anti-hypertensive medication, any history of congestive heart failure
- Chronic HTN arm:evidence of superimposed preeclampsia at the time of enrollment (headache, proteinuria, peripheral edema, or visual changes), any history of congestive heart failure
- Pre-eclampsia arm:history of congestive heart failure, pretreatment with anti-hypertensive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of Serum BNP to Distinguish Pre-Eclampsia From Hypertension in Pregnancy
Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming pregnant.B-type (also known as brain) natriuretic peptide (BNP) is known to be made and released from the heart ventricles when the heart is strained. There is also evidence that BNP is secreted in the placenta, and may increase in preeclampsia and chronic hypertension in pregnancy.The purpose of the study is to determine if a maternal blood sample analyzed for the quantity of BNP is helpful in differentiating between pre-eclampsia and chronic high blood pressure.
Read the detailed description
Preeclampsia is a frequent complication of pregnancy. The chief concern is that preeclampsia may progress to end-organ damage, with resultant deterioration of both the mother and the fetus. As a result, women with significant preeclampsia may have their labor accelerated or even require caesarian section. The diagnosis is made based on a constellation of non-specific symptoms, including headache, vision changes, proteinuria, and hypertension. The diagnosis becomes even more difficult to establish when the patient has chronic hypertension prior to her pregnancy.
In many Emergency Departments across the country, emergency physicians are faced with patients that have had either sporadic or non-existent prenatal care. Patients may often not know what their blood pressure was before their pregnancy. Records may not exist or be available for the emergency physician to make an accurate decision. Patients are often transferred to a tertiary care center for obstetrical admission when the diagnosis is unclear, as outlying areas are increasingly without obstetrical coverage. The availability of a sensitive and specific test for the presence of preeclampsia, or gestational hypertension superimposed on chronic hypertension, would allow the emergency physician to avoid costly hospital admissions or transfers while provide safe and effective care for the patient.
B-type or brain type natriuretic peptide (BNP) is a 32-amino acid peptide secreted primarily by the cardiac ventricles under conditions of ventricular wall strain. In addition, it has been demonstrated that BNP is also secreted in the human amnion during pregnancy. Small studies in the international literature suggest that serum BNP is elevated in preeclamptic patients and patients with chronic hypertension in pregnancy. A novel fluorescent immunoassay technique, the Biosite Triage BNP assay, utilizes murine fluorescent labeled antibodies to detect and quantify serum BNP levels. The Triage assay is designed for clinical use, with an estimated laboratory turnaround time of fifteen minutes (Biosite Triage BNP product insert). The Triage assay has gained acceptance as a highly sensitive and specific tool to assist in the rapid diagnosis of congestive heart failure exacerbation; its utility in the preeclamptic population has not been assessed.
- Conditions
- Preeclampsia
- Keywords
- Natriuretic Peptide Brain
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | Pregnant women in the third trimester with normal blood pressure this pregnancy and no history of HTN or pre-eclampsia in a previous pregnancy | |
| Chronic Hypertensive | Pregnant women in their third trimester with known hypertension prior to the current pregnancy | |
| Pre-eclampsia | Pregnant women in their third trimester who meet ACOG diagnostic criteria for pre-eclampsia |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startFeb 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Defined population
- Time perspective
- Other
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Investigators
- Brian C Hiestand, MD, Principal investigator, Ohio State University Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533871
- Sponsor's protocol ID
- 2003H0020
- Status last verified
- Sep 2007
- First submitted
- 21 Sep 2007
- Last updated
- 24 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Serum BNP to Distinguish Pre-Eclampsia From Hypertension in Pregnancy
- ClinicalTrials.gov ID
- NCT00533871
- Acronym / sponsor ID
- 2003H0020
- Conditions
- Preeclampsia
- Keywords
- Natriuretic Peptide Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Jun 2005 (actual)
- First posted
- 24 Sep 2007 (estimated)
- 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.
Preeclampsia is a common disease state occurring in the third trimester of pregnancy, with an incidence of approximately 5-10% in the US. Hypertension (high blood pressure), a primary symptom of pre-eclampsia, may be present in women who were hypertensive prior to becoming pregnant.B-type (also known as brain) natriuretic peptide (BNP) is known to be made and released from the heart ventricles when the heart is strained. There is also evidence that BNP is secreted in the placenta, and may increase in preeclampsia and chronic hypertension in pregnancy.The purpose of the study is to determine if a maternal blood sample analyzed for the quantity of BNP is helpful in differentiating between pre-eclampsia and chronic high blood pressure.
Detailed description
Preeclampsia is a frequent complication of pregnancy. The chief concern is that preeclampsia may progress to end-organ damage, with resultant deterioration of both the mother and the fetus. As a result, women with significant preeclampsia may have their labor accelerated or even require caesarian section. The diagnosis is made based on a constellation of non-specific symptoms, including headache, vision changes, proteinuria, and hypertension. The diagnosis becomes even more difficult to establish when the patient has chronic hypertension prior to her pregnancy.
In many Emergency Departments across the country, emergency physicians are faced with patients that have had either sporadic or non-existent prenatal care. Patients may often not know what their blood pressure was before their pregnancy. Records may not exist or be available for the emergency physician to make an accurate decision. Patients are often transferred to a tertiary care center for obstetrical admission when the diagnosis is unclear, as outlying areas are increasingly without obstetrical coverage. The availability of a sensitive and specific test for the presence of preeclampsia, or gestational hypertension superimposed on chronic hypertension, would allow the emergency physician to avoid costly hospital admissions or transfers while provide safe and effective care for the patient.
B-type or brain type natriuretic peptide (BNP) is a 32-amino acid peptide secreted primarily by the cardiac ventricles under conditions of ventricular wall strain. In addition, it has been demonstrated that BNP is also secreted in the human amnion during pregnancy. Small studies in the international literature suggest that serum BNP is elevated in preeclamptic patients and patients with chronic hypertension in pregnancy. A novel fluorescent immunoassay technique, the Biosite Triage BNP assay, utilizes murine fluorescent labeled antibodies to detect and quantify serum BNP levels. The Triage assay is designed for clinical use, with an estimated laboratory turnaround time of fifteen minutes (Biosite Triage BNP product insert). The Triage assay has gained acceptance as a highly sensitive and specific tool to assist in the rapid diagnosis of congestive heart failure exacerbation; its utility in the preeclamptic population has not been assessed.
Study design
- Observational model
- Defined population
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | –Pregnant women in the third trimester with normal blood pressure this pregnancy and no history of HTN or pre-eclampsia in a previous pregnancy |
| Chronic Hypertensive | – | –Pregnant women in their third trimester with known hypertension prior to the current pregnancy |
| Pre-eclampsia | – | –Pregnant women in their third trimester who meet ACOG diagnostic criteria for pre-eclampsia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women age 18 or older at 34 or more weeks of pregnancy
- Control arm:normal blood pressure during pregnancy
- Chronic HTN arm: known to have HTN predating this gestation
- Pre-eclampsia arm:meet ACOG diagnostic criteria for pre-eclampsia this pregnancy and present to labor and delivery for evaluation and/ or treatment
Key exclusion criteria (6 listed)
- minors, prisoners,unable to provide consent
- multiple gestation
- currently in labor
- Control arm:presence of hypertension, a history of gestational hypertension, current therapy with an anti-hypertensive medication, any history of congestive heart failure
- Chronic HTN arm:evidence of superimposed preeclampsia at the time of enrollment (headache, proteinuria, peripheral edema, or visual changes), any history of congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Sep 2007.
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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.
Brian C Hiestand, MD principal investigator
Ohio State University Department of Emergency Medicine
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 Preeclampsia, run by Ohio State 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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 24 Sep 2007. 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.
Where can I read the original study information?
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 24 Sep 2007; AzTrials last refreshed its copy on 29 Oct 2026.