Hypertension in PregnancyNCT00412230
Insulin Resistance and Hypertensive Disorders in Pregnancy
An observational study of Hypertension in Pregnancy and Diabetes Mellitus in Pregnancy, run by University of Messina at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy, Diabetes Mellitus in Pregnancy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2006to Jun 2008
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant outpatients
Who may be able to join
- PCOS, BMI>/=30
- previous pregnancy affected by hypertension or gestational diabetes
- thrombophilia
- Type I or II diabetes mellitus
- autoimmune diseases
- twin pregnancy
- renal diseases
- previous pre-eclampsia in relatives
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Insulin Resistance in Gestational Hypertension and in Preeclampsia.
The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.
- Keywords
- Pre-eclampsia, Gestational diabetes, Insulin resistance, hypertension in pregnancy
- Medical subject headings
- Hypertension, Pregnancy-Induced, Diabetes, Gestational, Pre-Eclampsia, Insulin Resistance
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 |
|---|---|---|
| no treatment | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startOct 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Investigators
- Rosario D'Anna, Associate Professor, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412230
- Sponsor's protocol ID
- 120254
- Status last verified
- Feb 2009
- First submitted
- 15 Dec 2006
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Insulin Resistance in Gestational Hypertension and in Preeclampsia.
- ClinicalTrials.gov ID
- NCT00412230
- Acronym / sponsor ID
- 120254
- Keywords
- Pre-eclampsia, Gestational diabetes, Insulin resistance, hypertension in pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Dec 2006 (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.
The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no treatment | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant outpatients
Key inclusion criteria (8 listed)
- PCOS, BMI>/=30
- previous pregnancy affected by hypertension or gestational diabetes
- thrombophilia
- Type I or II diabetes mellitus
- autoimmune diseases
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 18 Feb 2009.
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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.
Rosario D'Anna, Associate Professor principal investigator
University of Messina
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 Hypertension in Pregnancy and Diabetes Mellitus in Pregnancy, run by University of Messina at 1 site in Italy.
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 8 inclusion and 0 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 18 Feb 2009. 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 Italy. 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.
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 18 Feb 2009.