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

• Conditions: Basal Proteinuria in Pregnancy

• Registration Number: NCT02092064
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF).

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 Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19
• Study Start: 2014-04
• Primary Completion: 2014-10
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• pregnant patients with FMF

Exclusion Criteria

• multiple pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in proteinuria correlation to the adverse outcomes of pregnancy	6 months

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity Hospital; 🇹🇷 Ankara, Altindag, Turkey