P-wave Duration and Dispersion in Intrahepatic Cholestasi... | NCT01906827

Studies
P-wave Duration and Dispersion in Intrahepatic Cholestasis of Pregnancy

NCT01906827

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Status

Unknown status

Last Update Posted

Mar 18, 2014Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

Intrahepatic Cholestasis of Pregnancy
Arrhythmia

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

May 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Jul 20, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayse Kirbas, ayse kirbas, Zekai Tahir Burak Women's Health Research and Education HospitalPrincipal Investigator

Lead Sponsor

Zekai Tahir Burak Women's Health Research and Education HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Label	Type	Description	Intervention Names
pregnant with ICP		pregnant with ICP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Pregnants who with ICP

Exclusion Criteria:

Chronic liver disease
Disease during current pregnancy
Multiple pregnancies

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

The pregnant women with intrahepatic cholestasis who admitted our clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ayse kirbas, md	Contact	533 646 92 13		ayseozdemirkirbas@hotmail.com
ozgur kirbas, md	Contact	505 799 18 23		ozgurkirbas@yahoo.com

Overall Officials

Name	Affiliation	Role
ayse kirbas, md	Zekai Tahir Burak Women's Health Research and Education Hospital	Principal Investigator
ozgur kirbas, md	Yuksek Ihtisas Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zekai Tahir Burak Maternity Teaching Hospital	Recruiting	Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
C535932	Intrahepatic Cholestasis of Pregnancy
D001145	Arrhythmias, Cardiac
D002779	Cholestasis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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