Intrahepatic Cholestasis of PregnancyNCT02480478
Serum Autotaxin Levels in Cholestasis of Pregnancy
An observational study of Intrahepatic Cholestasis of Pregnancy, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who are admitted to obstetrics and gynecology department due to cholestasis of pregnancy
Who may be able to join
- Clinical diagnosed cholestasis of pregnancy patients
Who cannot join
- acute or chronic liver disease
- acute or chronic gallbladder disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Etfal Training and Research Hospital
Istanbul, 34371
Hakan Erenel, MD, OB/GYN, 00905063092995, hakanerenel@yahoo.com
About this study
Official title: Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.
Read the detailed description
Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Intrahepatic Cholestasis of Pregnancy
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intrahepatic cholestasis of pregnancy | 5 ml whole blood sample is going to collect from intrahepatic cholestasis of pregnancy group for the assessment of serum autotaxin levels | |
| healthy control group | 5 ml of whole blood is going to taken from healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum autotaxin levels in cholestasis of pregnancy
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Erenel, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Hakan Erenel, MD,OBGYN, Study director, Sisli Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480478
- Sponsor's protocol ID
- 518
- Status last verified
- Apr 2016
- First submitted
- 21 Jun 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Serum Autotaxin Levels in Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT02480478
- Acronym / sponsor ID
- 518
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- Intrahepatic Cholestasis of Pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrahepatic cholestasis of pregnancy is the most common liver disease in pregnancy. It is is a pregnancy-specific liver disorder with onset mainly in the third trimester of pregnancy. ICP is characterized by pruritus, elevated serum fasting bile salts and transaminases and an increased risk of adverse fetal outcomes. Serum autotaxin levels were found highly sensitive and specific biomarker to to differentiate ICP from other pregnancy-related liver disorders or pruritic dermatoses. The purpose of the study is to determine the diagnostic accuracy of serum autotaxin activity in cholestasis of pregnancy.
Detailed description
Collected data will enable us to compare serum autotaxin levels in cholestasis of pregnancy and healthy control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrahepatic cholestasis of pregnancy | – | –5 ml whole blood sample is going to collect from intrahepatic cholestasis of pregnancy group for the assessment of serum autotaxin levels |
| healthy control group | – | –5 ml of whole blood is going to taken from healthy control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are admitted to obstetrics and gynecology department due to cholestasis of pregnancy
Key inclusion criteria (1 listed)
- Clinical diagnosed cholestasis of pregnancy patients
Key exclusion criteria (2 listed)
- acute or chronic liver disease
- acute or chronic gallbladder disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum autotaxin levels in cholestasis of pregnancy
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Erenel, MD,OBGYN study director
Sisli Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholestasis of Pregnancy, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Erenel, MD,OBGYN (00905063092995, hakanerenel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum autotaxin levels in cholestasis of pregnancy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.