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

NCT ID: NCT02092064

Last Updated: 2014-03-19

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Basal Proteinuria in Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* pregnant patients with FMF

Exclusion Criteria

* multiple pregnancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zekai Tahir Burak Women's Health Research and Education Hospital

OTHER

Sponsor Role lead

Responsible Party

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cantekin iskender

Perinatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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dilek uygur

Role: PRINCIPAL_INVESTIGATOR

zekai tahir burak hospital

Locations

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Zekai Tahir Burak Maternity Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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cantekin iskender, md

Role: CONTACT

+90- 312-306-5000

ayse kirbas

Role: CONTACT

+90- 312-306-5000

References

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Turgal M, Selcuk I, Ozyuncu O. Pregnancy outcome of five patients with renal amyloidosis regarding familial Mediterranean fever. Ren Fail. 2014 Mar;36(2):306-8. doi: 10.3109/0886022X.2013.846863. Epub 2013 Oct 29.

Reference Type RESULT
PMID: 24168456 (View on PubMed)

Yasar O, Iskender C, Kaymak O, Taflan Yaman S, Uygur D, Danisman N. Retrospective evaluation of pregnancy outcomes in women with familial Mediterranean fever. J Matern Fetal Neonatal Med. 2014 May;27(7):733-6. doi: 10.3109/14767058.2013.837446. Epub 2013 Sep 25.

Reference Type RESULT
PMID: 23981183 (View on PubMed)

Other Identifiers

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Basal Proteinuria in FMF

Identifier Type: -

Identifier Source: org_study_id

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