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Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy (CREATION-P)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068002
First Posted: February 12, 2010
Last Update Posted: February 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
  Purpose
Cardiovascular & echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.

Condition Phase
Pregnancy Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women [ Time Frame: 1 Year ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control, normotensive, pregnancy
Control, normotensive, pregnancy
hypertension, pregnancy, no treatment
hypertension, pregnancy, no treatment
hypertension, pregnancy, drug treatment
hypertension, pregnancy, drug treatment

Detailed Description:
Cardiovascular & echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women. Also,comparing echocardiographic parameters in hypertensive pregnant women being treated with either alfa methyl dopa or labetolol.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant Women
Criteria

Inclusion Criteria:

  • hypertension during pregnancy: Chronic or pregnancy induced

Exclusion Criteria:

  • Inability to sign informed consent
  Contacts and Locations
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): NCT01068002


Contacts
Contact: Limor I Bushari, MD 9724502000741 limor_il@clalit.org.il
Contact: Nachum Zohar, MD 97254696562 nachum_zo@clalit.org.il

Locations
Israel
Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Limor I Bushari, MD    972502000741    limor_il@clalit.org.il   
Contact: Nachum Zohar    972547696562    nachun_zo@clalit.org.il   
Principal Investigator: Limor I Bushari, MD         
Sub-Investigator: Raed Salim, MD         
Sub-Investigator: Nachum Zohar, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Limor I Bushari Heart Institute, Ha'Emek Medical Center
  More Information

Responsible Party: Dr. Limor Ilan- Bushari, Ha'Emek Medical Center
ClinicalTrials.gov Identifier: NCT01068002     History of Changes
Other Study ID Numbers: 071-09-EMC
First Submitted: February 11, 2010
First Posted: February 12, 2010
Last Update Posted: February 12, 2010
Last Verified: February 2010

Keywords provided by HaEmek Medical Center, Israel:
Hypertension Pregnancy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases


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