Comparison of Urine Protein/Creatinine Ratio With 24-hour Urine Protein Excretion in Woman With Hypertensive Disorders

NCT ID: NCT01508208

Last Updated: 2018-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypertension, Pregnancy-Induced

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hypertensive disorder of pregnancy

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.

Group Type OTHER

Hypertensive disorder of pregnancy

Intervention Type OTHER

Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.

Interventions

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Hypertensive disorder of pregnancy

Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women with 28 weeks or more of gestation.
* Complete collection of the 24 hour urine sample.

Exclusion Criteria

* 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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Coordinator of Research & Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo A Reyes, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Joanna Buitrago, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas H

Panama City, , Panama

Site Status

Countries

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Panama

Other Identifiers

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MHST2011-07

Identifier Type: -

Identifier Source: org_study_id

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