- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01068002
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy (CREATION-P)
February 11, 2020 updated by: HaEmek Medical Center, Israel
Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)
Cardiovascular & echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Afula, Israel, 18101
- Ha'Emek Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Pregnant Women
Description
Inclusion Criteria:
- hypertension during pregnancy: Chronic or pregnancy induced
Exclusion Criteria:
- Inability to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Control, normotensive, pregnancy
|
hypertension, pregnancy, no treatment
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hypertension, pregnancy, drug treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Limor I Bushari, Heart Institute, Ha'Emek Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2009
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
February 11, 2010
First Submitted That Met QC Criteria
February 11, 2010
First Posted (ESTIMATE)
February 12, 2010
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 071-09-EMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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