PregnancyCREATION-PNCT01068002
Cardiovascular an Echocardiographic Assessment in Hypertension During Pregnancy
An observational study of Pregnancy, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant Women
Who may be able to join
- hypertension during pregnancy: Chronic or pregnancy induced
Who cannot join
- Inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Hypertension Pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control, normotensive, pregnancy | Control, normotensive, pregnancy | |
| hypertension, pregnancy, no treatment | hypertension, pregnancy, no treatment | |
| hypertension, pregnancy, drug treatment | hypertension, pregnancy, drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment
Measured: 1 year
Secondary outcomes (1)
Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Limor I Bushari, Principal investigator, Heart Institute, Ha'Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068002
- Sponsor's protocol ID
- 071-09-EMC
- Acronym
- CREATION-P
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2010
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension During Pregnancy: Cardiovascular & Echocardiographic Assessment: CREATION - P (01)
- ClinicalTrials.gov ID
- NCT01068002
- Acronym / sponsor ID
- CREATION-P / 071-09-EMC
- Conditions
- Pregnancy
- Keywords
- Hypertension Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular \& echocardiographic assessment in pregnant women with hypertension during their pregnancy in comparison to Pregnant normotensive women.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control, normotensive, pregnancy | – | –Control, normotensive, pregnancy |
| hypertension, pregnancy, no treatment | – | –hypertension, pregnancy, no treatment |
| hypertension, pregnancy, drug treatment | – | –hypertension, pregnancy, drug treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant Women
Key inclusion criteria (1 listed)
- hypertension during pregnancy: Chronic or pregnancy induced
Key exclusion criteria (1 listed)
- Inability to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment
Time frame: 1 year
1 secondary outcome
Primary outcome, Impact of alfa methyl dopa and labetolol on cardiovascular parameters in pregnant women
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limor I Bushari principal investigator
Heart Institute, Ha'Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension impact on cardiovascular echocardiographic parameters and obstetric parameters in pregnant women with or without treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.