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Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

to Investigate the Maternal Serum IL-17 Levels in Pregnant Women With Intrahepatic Cholestasis of Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01898832
Enrollment
30
Registered
2013-07-12
Start date
2013-07-31
Completion date
2014-07-31
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

Cholestasis, pregnant, interleukin 17

Brief summary

The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of pregnancy.

Detailed description

Intrahepatic cholestasis of pregnancy (ICP) is the most prevalent pregnancy-specific liver disease. It occurs mainly in the second or third trimester of pregnancy. It typically resolves after delivery spontaneously but it is associated with an increased risk of adverse fetal outcomes. The cause of ICP is heterogeneous, pathophysiology is poorly understood and therapies have been empiric. Genetic predispositions, environmental influences, dietary factors and hormonal influences have been studied and cited in the literature. Comparing with placebo, ursodeoxycholic acid (UDCA) has been shown improvement in treatment of pruritus in previous studies. S-adenosylmethionine, guar gum, activated charcoal, dexamethasone, cholestyramine, etc. are not effective in the treatment of symptoms. CD4+ T cells are an essential regulators of immune responses and inflammatory diseases. They are also called chief of orchestra cells of immune system. The balance between T helper-(Th)1, Th-2 and Th-17 cells and their cytokinergic interaction are crucial for the response of the organism. Th17 and its specific cytokine IL-17 are responsible for pathogenesis of autoimmune diseases as autoimmune uveitis, experimental autoimmune encephalomyelitis in animal models and potentially also in human autoimmune diseases such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, psoriasis, primary biliary cirrhosis. Recently, IL-17 targeted therapies (secukinumab, ixekizumab and brodalumab) are being studied in Phase III clinical trials to evaluate their overall efficacy and safety for certain autoimmune diseases. Th-17 levels have been investigated in normal and abnormal pregnancies and results were incompatible with each other. Some researchers have said that the level of IL-17 increased during pregnancy but the others not. Low serum IL-17 is associated with premature birth. Up-regulation of the IL-17 is associated with preeclampsia. K. Harada et all. (2009) demonstrated that IL-17-positive cells are associated with the chronic inflammation of bile ducts in primary biliary cirrhosis(PBC). Also, some authors demonstrated that Th-17-related cytokines were increased significantly in patients with PBC. Maho Ichikawa et all. presented a case of male newborn infant who showed progressive severe cholestasis with selectively high Levels of Serum IL- 17. Based on all this information, we decided to investigate maternal and fetal serum IL-17 levels of pregnants with ICP and the effects of UDCA therapy on it and find out if Th-17 cells have a role in progress of ICP.

Interventions

None listed

Sponsors

Zekai Tahir Burak Women's Health Research and Education Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

Clinical diagnosis of ICP \-

Exclusion criteria

multiple pregnancies known chronic illness

Design outcomes

Primary

MeasureTime frame
il-17 levels12 months

Countries

Turkey (Türkiye)

Contacts

Primary Contactayse kirbas, md
ayseozdemirkirbas@hotmail.com+ 90 533 646 92 13
Backup Contactayse kirbas
+90 312-306-5000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026