P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy

Brief Title

P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy


Brief 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. 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 Type

Observational


Primary Outcome

change in the range of P-wave Duration and Dispersion


Condition

Intrahepatic Cholestasis of Pregnancy


Study Arms / Comparison Groups

 pregnant with ICP
Description:  pregnant with ICP

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

90

Start Date

July 2013

Completion Date

June 2014

Primary Completion Date

May 2014

Eligibility Criteria

        Inclusion Criteria:

        - Pregnants who with ICP

        Exclusion Criteria:

          -  Chronic liver disease

          -  Disease during current pregnancy

          -  Multiple pregnancies
      

Gender

Female

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

ayse kirbas, md, 533 646 92 13, [email protected]

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT01906827

Organization ID

zekai tahir burak- p wave


Responsible Party

Principal Investigator

Study Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital


Study Sponsor

ayse kirbas, md, Principal Investigator, Zekai Tahir Burak Women's Health Research and Education Hospital


Verification Date

July 2013