Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever

March 18, 2014 updated by: cantekin iskender, Zekai Tahir Burak Women's Health Research and Education Hospital
to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF).

Study Overview

Status

Unknown

Conditions

Detailed Description

Familial Mediterranean fever (FMF) is also known recurrent polyserositis the most common hereditary recurrent febrile disorder. It is characterized by paroxysmal episodes of the high fever and signs of serositis-peritonitis, pleuritis, synovitis. Between these attacks, patients are usually asymptomatic. FMF mainly affects populations of the Mediterranean region such as Turks.

The diagnosis of FMF may be extremely difficult to establish in the presence of atypical signs, and absence of family history . Colchicine is effective in most of the patients with FMF. The one the most important complications of FMF is the development of renal amyloidosis. It potentially progress sequentially through preclinical, proteinuric, nephrotic, azotemic and uremic stages to end stage renal disease if not treated properly with colchicine. Previous studies suggests that colchicine does not appear to be a major human teratogen, and, probably, has no cytogenetic effect.

FMF affects females mainly in their childbearing years. FMF is associated with higher rates of recurrent abortion, premature rupture of membranes (PROM) and preterm birth. Despite of adverse outcomes have been reported in pregnants with FMF the outcome of pregnancies in FMF appear favorable with the healthy population since the usingof the colchicine. Although the effect of pregnancy on the course of FMF related amyloidosis is controversial, it is generally accepted that renal function may disrupt during pregnancy.

Few studies have investigated the effect of FMF complications (amyloidosis and nephrotic syndrome) on pregnancy course.

The aim of this study is to investigate the effect of basal proteinuria on pregnancy outcome of patients with Familial Mediterranean fever (FMF).

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey
        • Zekai Tahir Burak Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant patients with FMF

Description

Inclusion Criteria:

  • pregnant patients with FMF

Exclusion Criteria:

  • multiple pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in proteinuria correlation to the adverse outcomes of pregnancy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Principal Investigator: dilek uygur, Zekai Tahir Burak Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Basal Proteinuria in FMF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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