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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01068002
First received: February 11, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Limor Ilan- Bushari, Ha'Emek Medical Center
ClinicalTrials.gov Identifier: NCT01068002     History of Changes
Other Study ID Numbers: 071-09-EMC
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:
Hypertension Pregnancy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013