Intrahepatic Cholestasis of PregnancyNCT01906827
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
An observational study of Intrahepatic Cholestasis of Pregnancy and Arrhythmia, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy, Arrhythmia
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2013to Jun 2014
- 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 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The pregnant women with intrahepatic cholestasis who admitted our clinic
Who may be able to join
- Pregnants who with ICP
Who cannot join
- Chronic liver disease
- Disease during current pregnancy
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital
Ankara
ayse kirbas, md, 533 646 92 13, ayseozdemirkirbas@hotmail.com
ozgur kirbas, md, 505 7991823
About this study
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
Read the detailed description
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease. The most frequent laboratory abnormality is elevation of serum bile acid levels in ICP.
Bile acids increases both maternal and fetal circulation in ICP. The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus.
P-wave dispersion (PWD) is defined as the difference between the maximum and the minimum P-wave durations measured on a 12-lead surface electrocardiogram (ECG). Increased P-wave duration and PWD have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity.
So the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
The aim of this study is to investigate maternal P-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .
- Conditions
- Intrahepatic Cholestasis of Pregnancy, Arrhythmia
- Keywords
- cholestasis, pregnancy, p wave dispersion, arrhythmia
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Arrhythmias, Cardiac, Cholestasis
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 |
|---|---|---|
| pregnant with ICP | pregnant with ICP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the range of P-wave Duration and Dispersion
A 12-lead surface ECG will obtain for all pregnants with icp in the supine position after a rest period of 10 minutes. Two consecutive cycles will record at a speed of 50 mm/sec and with an amplitude of 10mm/mV. All ECGs will examine by a designated cardiologist blinded to patient details. To improve accuracy, measurements will made using calipers and magnifying lens. Only participants with normal sinus rhythm on ECG will include in the final analysis
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 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014 (estimated)
- Study completionJun 2014 (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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- ayse kirbas, md, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospitalozgur kirbas, md, Principal investigator, Yuksek Ihtisas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906827
- Sponsor's protocol ID
- zekai tahir burak- p wave
- Status last verified
- Jul 2013
- First submitted
- 20 Jul 2013
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
- ClinicalTrials.gov ID
- NCT01906827
- Acronym / sponsor ID
- zekai tahir burak- p wave
- Conditions
- Intrahepatic Cholestasis of Pregnancy, Arrhythmia
- Keywords
- cholestasis, pregnancy, p wave dispersion, arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 24 Jul 2013 (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.
The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Bile acids may alter maternal cardiomyocyte function like fetus.Increased P-wave duration and P-wave dispersion have been reported in various clinical settings. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
Detailed description
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease. The most frequent laboratory abnormality is elevation of serum bile acid levels in ICP.
Bile acids increases both maternal and fetal circulation in ICP. The bile acids has been demonstrated to cause arrhythmia and abnormal calcium dynamics in cultured neonatal rat cardiomyocytes. Raised maternal bile acid levels have been associated with fetal distress and arrhytmia in fetus.
P-wave dispersion (PWD) is defined as the difference between the maximum and the minimum P-wave durations measured on a 12-lead surface electrocardiogram (ECG). Increased P-wave duration and PWD have been reported in various clinical settings, including atrial flutter, coronary artery disease, hypertension, rheumatic mitral stenosis, mitral annular calcification, obstructive sleep apnea, and obesity.
So the investigators think that bile acids may alter maternal cardiomyocyte function as fetus. The investigators hypothesized that PWD and p wave duration may affect in pregnancy with ICP.
The aim of this study is to investigate maternal P-wave duration and dispersion changes in pregnant women with intrahepatic cholestasis of pregnancy .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant with ICP | – | –pregnant with ICP |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The pregnant women with intrahepatic cholestasis who admitted our clinic
Key inclusion criteria (1 listed)
- Pregnants who with ICP
Key exclusion criteria (3 listed)
- Chronic liver disease
- Disease during current pregnancy
- Multiple pregnancies
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
change in the range of P-wave Duration and Dispersion
Time frame: one year
A 12-lead surface ECG will obtain for all pregnants with icp in the supine position after a rest period of 10 minutes. Two consecutive cycles will record at a speed of 50 mm/sec and with an amplitude of 10mm/mV. All ECGs will examine by a designated cardiologist blinded to patient details. To improve accuracy, measurements will made using calipers and magnifying lens. Only participants with normal sinus rhythm on ECG will include in the final analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
ayse kirbas, md principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
ozgur kirbas, md principal investigator
Yuksek Ihtisas 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 and Arrhythmia, run by Zekai Tahir Burak Women's Health Research and Education 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 3 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 18 Mar 2014. 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 ayse kirbas, md (533 646 92 13, ayseozdemirkirbas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the range of P-wave Duration and Dispersion (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 18 Mar 2014.