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Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192177
Recruitment Status : Unknown
Verified July 2014 by Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital

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.

Condition or disease
Pregnancy

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.
Study Start Date : September 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014


Group/Cohort
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.



Primary Outcome Measures :
  1. M30 value as Unit per Liter. [ Time Frame: Four months. ]

Secondary Outcome Measures :
  1. Percentage of delivery with cesarean section. [ Time Frame: Four months. ]

Biospecimen Retention:   None Retained
Maternal venous and umbilical cord blood.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.
Criteria

Inclusion Criteria:

  • Late second or third trimester of pregnancy.

Exclusion Criteria:

  • Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192177


Contacts
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Contact: Ali O Ersoy +905056579157 draliersoy@yahoo.com

Locations
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Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey
Contact: Ali O Ersoy    +905056579157    draliersoy@yahoo.com   
Principal Investigator: Ali O Ersoy         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
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Principal Investigator: Ali O Ersoy Medical doctor

Publications:
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Responsible Party: Ali Ozgur Ersoy, Medical Doctor, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02192177    
Other Study ID Numbers: M30 Intrahepatic cholestasis
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014
Keywords provided by Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital:
Apoptosis
intrahepatic cholestasis
obstetric outcomes
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases