Hypertension, Pregnancy-InducedNCT01508208
Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders
A study testing Hypertensive disorder of pregnancy in people with Hypertension, Pregnancy-Induced, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension, Pregnancy-Induced
- What is being tested?
- Hypertensive disorder of pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 sitePanama
- Study dates
- Mar 2012to Jul 2016
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women with 28 weeks or more of gestation.
- Complete collection of the 24 hour urine sample.
Who cannot join
- Failure to recollect the 24 hour urine sample.
- Pregestational Diabetes
- Kidney disease
- 24 hour urine protein > 8.0 g/dL or seric creatinine > 2.0 mg/dL (it could indicate kidney disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy
The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation.
The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
- Conditions
- Hypertension, Pregnancy-Induced
- Being tested
- Hypertensive disorder of pregnancy
- Keywords
- Hypertension, 24 hour urine protein, Protein/creatinine ratio
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertensive disorder of pregnancyOther
Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive disorder of pregnancy | Other | Patients with an hypertensive disorder of pregnancy (28 weeks or more of gestation)will collect a random sample of urine for a spot test (protein/creatinine ratio) and urine for 24 hours. The level of proteinuria will be determined in this sample. Receives: Other: Hypertensive disorder of pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
The number of patients with a 24 hour urine collection with a proteinuria > 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) > 0.2 (equivalent to the 24 hour test > 300 mg). This value will be used to calculate the Sensitivity and Specificity of the spot test.
Measured: Six months
Secondary outcomes (1)
Positive and Negative Predictive Value
The number of patients with a 24 hour urine collection with a proteinuria > 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) > 0.2 (equivalent to the 24 hour test > 300 mg). This value will be used to calculate the positive and negative predective value of the spot test.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Pregnancy-InducedStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo A Reyes, MD, Principal investigator, Saint Thomas Hospital, PanamaJoanna Buitrago, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508208
- Sponsor's protocol ID
- MHST2011-07
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2012
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Spot Test (Urine Protein/Creatinine Ratio) With 24 - Hour Urine Protein Excretion in Woman With Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT01508208
- Acronym / sponsor ID
- MHST2011-07
- Conditions
- Hypertension, Pregnancy-Induced
- Keywords
- Hypertension, 24 hour urine protein, Protein/creatinine ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Jan 2012 (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.
The presence of proteinuria (>300 mg/d) represents an important factor in the diagnosis and evaluation of the pregnant patient with an hypertensive disorder. The 24 hour collection of urine for proteinuria is the gold standard for the diagnosis of the condition and allows the physician to determine if an hypertensive disorder is related directly or not to the gestation.
The problem is the time it takes and the technical difficulties related to the sample collection. An alternative is the quantification of protein and creatinine in a random sample of urine. We seek to evaluate if this method is as affective as the gold standard in the diagnosis of proteinuria (>300 mg/d).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive disorder of pregnancy | Other | Other: Hypertensive disorder of pregnancyPatients with an hypertensive disorder of pregnancy (28 weeks or more of gestation)will collect a random sample of urine for a spot test (protein/creatinine ratio) and urine for 24 hours. The level of proteinuria will be determined in this sample. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women with 28 weeks or more of gestation.
- Complete collection of the 24 hour urine sample.
Key exclusion criteria (4 listed)
- Failure to recollect the 24 hour urine sample.
- Pregestational Diabetes
- Kidney disease
- 24 hour urine protein > 8.0 g/dL or seric creatinine > 2.0 mg/dL (it could indicate kidney disease).
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 |
|---|---|---|
| Hypertensive disorder of pregnancyCollection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein. | Other | Hypertensive disorder of pregnancy |
Primary outcome
Sensitivity and Specificity
Time frame: Six months
The number of patients with a 24 hour urine collection with a proteinuria > 300mg will be compared with the number of patients with a Spot Test (protein/creatinine ratio in a random urine sample) > 0.2 (equivalent to the 24 hour test > 300 mg). This value will be used to calculate the Sensitivity and Specificity of the spot test.
1 secondary outcome
Positive and Negative Predictive Value
Time frame: six months
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 4 Jan 2018.
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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.
Osvaldo A Reyes, MD principal investigator
Saint Thomas Hospital, Panama
Joanna Buitrago, MD principal investigator
Saint Thomas Hospital, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertensive disorder of pregnancy in people with Hypertension, Pregnancy-Induced, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 2 inclusion and 4 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 4 Jan 2018. 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 Panama. 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?
Sensitivity and Specificity (time frame: Six months). It is what the study was designed to measure, not a finding.
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 4 Jan 2018.