P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 20, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 18, 2014
July 1, 2013
10 months
July 20, 2013
March 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
one year
Study Arms (1)
pregnant with ICP
pregnant with ICP
Eligibility Criteria
The pregnant women with intrahepatic cholestasis who admitted our clinic
You may qualify if:
- \- Pregnants who with ICP
You may not qualify if:
- Chronic liver disease
- Disease during current pregnancy
- Multiple pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ayse kirbas, md
Zekai Tahir Burak Women's Health Research and Education Hospital
- PRINCIPAL INVESTIGATOR
ozgur kirbas, md
Yuksek Ihtisas Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ayse kirbas
Study Record Dates
First Submitted
July 20, 2013
First Posted
July 24, 2013
Study Start
July 1, 2013
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
March 18, 2014
Record last verified: 2013-07