Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.
1 other identifier
observational
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 12, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJuly 16, 2014
July 1, 2014
11 months
July 12, 2014
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
M30 value as Unit per Liter.
Four months.
Secondary Outcomes (1)
Percentage of delivery with cesarean section.
Four months.
Study Arms (2)
Group 1
Pregnant subjects diagnosed with obstetric cholestasis who didn't have any foreknown systemic disease.
Group 2
entirely healthy pregnant subjects, the control group.
Eligibility Criteria
Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.
You may qualify if:
- Late second or third trimester of pregnancy.
You may not qualify if:
- Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Ankara, Turkey (Türkiye)
Related 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.
PMID: 24678423BACKGROUNDDu Q, Zhang Y, Pan Y, Duan T. Lithocholic acid-induced placental tumor necrosis factor-alpha 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.
PMID: 23627780BACKGROUND
Biospecimen
Maternal venous and umbilical cord blood.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali O Ersoy
Medical doctor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
July 12, 2014
First Posted
July 16, 2014
Study Start
September 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
July 16, 2014
Record last verified: 2014-07