Apoptosis May Have a Role in Etiopathogenesis of Obstetric Cholestasis.

July 14, 2014 updated by: Ali Ozgur Ersoy, Zekai Tahir Burak Women's Health Research and Education Hospital
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Ali O Ersoy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who admitted our clinic without foreknown systemic diseases or multiple pregnancy.

Description

Inclusion Criteria:

  • Late second or third trimester of pregnancy.

Exclusion Criteria:

  • Foreknown systemic diseases, multiple pregnancy, smoking cigarettes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
M30 value as Unit per Liter.
Time Frame: Four months.
Four months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of delivery with cesarean section.
Time Frame: Four months.
Four months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

July 12, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M30 Intrahepatic cholestasis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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