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
hypertension, pregnancy, drug treatment

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.

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

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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