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 Women's Health Research and Education Hospital.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : March 18, 2014
|Condition or disease|
|Intrahepatic Cholestasis of Pregnancy Arrhythmia|
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|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||June 2014|
pregnant with ICP
pregnant with ICP
- 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
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
|Contact: ayse kirbas, md||533 646 92 firstname.lastname@example.org|
|Contact: ozgur kirbas, md||505 799 18 email@example.com|
|Zekai Tahir Burak Maternity Teaching Hospital||Recruiting|
|Contact: ayse kirbas, md 533 646 92 13 firstname.lastname@example.org|
|Contact: ozgur kirbas, md 505 7991823|
|Principal Investigator: ayse kirbas, md|
|Principal Investigator:||ayse kirbas, md||Zekai Tahir Burak Women's Health Research and Education Hospital|
|Principal Investigator:||ozgur kirbas, md||Yuksek Ihtisas Hospital|