P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy

March 16, 2014 updated by: Ayse Kirbas, Zekai Tahir Burak Women's Health Research and Education Hospital
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:
        • Contact:
          • ozgur kirbas, md
          • Phone Number: 505 7991823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The pregnant women with intrahepatic cholestasis who admitted our clinic

Description

Inclusion Criteria:

- Pregnants who with ICP

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
pregnant with ICP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Investigators

  • Principal Investigator: ozgur kirbas, md, Yuksek Ihtisas Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 16, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zekai tahir burak- p wave

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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