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

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ClinicalTrials.gov Identifier: NCT01068002
Recruitment Status : Unknown
Verified February 2010 by HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : February 12, 2010
Last Update Posted : February 12, 2010
Sponsor:
Information provided by:
HaEmek Medical Center, Israel

Brief Summary:
Cardiovascular & echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.

Condition or disease Phase
Pregnancy Phase 3

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.

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Group/Cohort
Control, normotensive, pregnancy
Control, normotensive, pregnancy
hypertension, pregnancy, no treatment
hypertension, pregnancy, no treatment
hypertension, pregnancy, drug treatment
hypertension, pregnancy, drug treatment



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

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


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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

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

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 Posted: February 12, 2010    Key Record Dates
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