Basal Proteinuria in PregnancyNCT02092064
Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever
An observational study of Basal Proteinuria in Pregnancy, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Basal Proteinuria in Pregnancy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Apr 2015
- How long will I take part?
- 8 Months
- Phase
- Observational
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant patients with FMF
Who may be able to join
- pregnant patients with FMF
Who cannot join
- multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Hospital
Ankara, Altindag
salim erkaya
About this study
to investigate the effect of basal proteinuria on pregnancy outcomes of patients with Familial Mediterranean fever (FMF).
Read the 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).
- Conditions
- Basal Proteinuria in Pregnancy
- Keywords
- basal proteinuria, FMF, pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
change in proteinuria correlation to the adverse outcomes of pregnancy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Basal Proteinuria in PregnancyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, cantekin iskender, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- dilek uygur, Principal investigator, zekai tahir burak hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092064
- Sponsor's protocol ID
- Basal Proteinuria in FMF
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24168456Yasar 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.
PubMed 23981183
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Basal Proteinuria Levels and Pregnancy Outcomes in Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT02092064
- Acronym / sponsor ID
- Basal Proteinuria in FMF
- Conditions
- Basal Proteinuria in Pregnancy
- Keywords
- basal proteinuria, FMF, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 19 Mar 2014 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant patients with FMF
Key inclusion criteria (1 listed)
- pregnant patients with FMF
Key exclusion criteria (1 listed)
- multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in proteinuria correlation to the adverse outcomes of pregnancy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Results publication: PubMed 24168456Turgal 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.
- Results publication: PubMed 23981183Yasar 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.
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.
dilek uygur principal investigator
zekai tahir burak hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Proteinuria in Pregnancy, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Mar 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cantekin iskender, md (+90- 312-306-5000, c_iskender@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in proteinuria correlation to the adverse outcomes of pregnancy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092064, which also lists 2 linked publications.
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 19 Mar 2014.