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NCT02192177 Clinical Trial

Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

Pregnancy Clinical Trial

Official title:
Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02192177
Other study ID # M30 Intrahepatic cholestasis
Secondary ID
Status Recruiting
Phase N/A
First received July 12, 2014
Last updated July 14, 2014
Start date September 2013
Est. completion date August 2014

Study information
Verified date July 2014
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact Ali O Ersoy
Phone +905056579157
Email draliersoy@yahoo.com
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Intrahepatic cholestasis of pregnancy is a disease specific to pregnancy period; especially late second and third trimester. We aimed to investigate the role of apoptosis in etiopathogenesis of obstetric cholestasis.

Description:

M30 (caspases cleaved Cytokeratin-18 (CK-18) fragment) is a specific apoptosis marker. We aimed to use it to evaluate the apoptotic process.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Late second or third trimester of pregnancy.

Exclusion Criteria:

- Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Zekai Tahir Burak Maternity Teaching Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Del Ben M, Polimeni L, Baratta F, Bartimoccia S, Carnevale R, Loffredo L, Pignatelli P, Violi F, Angelico F. Serum Cytokeratin-18 Is Associated with NOX2-Generated Oxidative Stress in Patients with Nonalcoholic Fatty Liver. Int J Hepatol. 2014;2014:784985. doi: 10.1155/2014/784985. Epub 2014 Jan 29. — View Citation

Du Q, Zhang Y, Pan Y, Duan T. Lithocholic acid-induced placental tumor necrosis factor-a upregulation and syncytiotrophoblast cell apoptosis in intrahepatic cholestasis of pregnancy. Hepatol Res. 2014 May;44(5):532-41. doi: 10.1111/hepr.12150. Epub 2013 May 31. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary M30 value as Unit per Liter. Four months. No
Secondary Percentage of delivery with cesarean section. Four months. No
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