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P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy

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ClinicalTrials.gov Identifier: NCT01906827
Recruitment Status : Unknown
Verified July 2013 by Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was:  Recruiting
First Posted : July 24, 2013
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital

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.

Condition or disease
Intrahepatic Cholestasis of Pregnancy Arrhythmia

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
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : July 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014


Group/Cohort
pregnant with ICP
pregnant with ICP



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The pregnant women with intrahepatic cholestasis who admitted our clinic
Criteria

Inclusion Criteria:

- Pregnants who with ICP

Exclusion Criteria:

  • Chronic liver disease
  • Disease during current pregnancy
  • Multiple pregnancies

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): NCT01906827


Contacts
Contact: ayse kirbas, md 533 646 92 13 ayseozdemirkirbas@hotmail.com
Contact: ozgur kirbas, md 505 799 18 23 ozgurkirbas@yahoo.com

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Turkey
Contact: ayse kirbas, md    533 646 92 13    ayseozdemirkirbas@hotmail.com   
Contact: ozgur kirbas, md    505 7991823      
Principal Investigator: ayse kirbas, md         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
Investigators
Principal Investigator: ayse kirbas, md Zekai Tahir Burak Women's Health Research and Education Hospital
Principal Investigator: ozgur kirbas, md Yuksek Ihtisas Hospital

Responsible Party: Ayse Kirbas, ayse kirbas, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01906827     History of Changes
Other Study ID Numbers: zekai tahir burak- p wave
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: July 2013

Keywords provided by Ayse Kirbas, Zekai Tahir Burak Maternity and Teaching Hospital:
cholestasis
pregnancy
p wave dispersion
arrhythmia

Additional relevant MeSH terms:
Cholestasis
Cholestasis, Intrahepatic
Pregnancy Complications
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases