PregnancyNCT02340442
DVA Risk Pregnancy
An observational study of Pregnancy and High Risk Pregnancies, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Maternal obesity, overweight and hypertensive disorders are among the most important risk factors for complications during pregnancy. Several lines of evidence indicate that overweight or obese women, as well as women with hypertensive disorders show increased risks of preterm birth before 32 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk Pregnancies
- What is being tested?
- Obstetrical care parameters, DVA measurements and Fundus photographs
- How many people
- 120 participants
- Where
- 2 sitesAustria
- Study dates
- Oct 2013to Dec 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited form the gynecology department and the department of clinical pharmacology
Who may be able to join
- • Age >18 years
- Written informed consent
- Pregnancy at screening
- Normal ophthalmic findings, unless the investigator considers a finding clinically irrelevant.
- Ametropy <= 3,5 Dpt.
- For pregnant women with preeclampsia:
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- Systolic BP ≥140 mmHg, or diastolic BP ≥90 mmHg on at least 2 occasions AND
- Proteinuria (≥300 mg/day) after 20 weeks of gestation in preeclampsia
- Pregnant at the time of confirming diagnosis of preeclampsia
- For pregnant women with obesity:
- Pre-pregnancy BMI ≥30 as assessed from medical history
- According to the WHO BMI classification:
- Underweight (less than 18.5)
- normal weight (18.5-24.9)
- overweight (25-29.9)
- obese class I (30 -34.9)
- obese class II (35-39.9)
- obese class III (40 or more) For non-pregnant control subjects
- Age >18 years
- Written informed consent
- Not pregnant at screening
- Normal ophthalmic and medical findings, unless the investigator considers a finding clinically irrelevant.
- Ametropy <= 3,5 Dpt.
Who cannot join
- Diabetes mellitus type I or II
- Renal failure requiring dialysis
- Cirrhosis of liver
- Collagenosis
- Vasculitis
- Paraproteinaemia
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- Alcohol abuse
- Amyloidosis
- Clinical signs of polyneuropathy
- Any other clinical finding, unless the clinical investigator considers a finding to be non clinically significant.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Department of Clinical Pharmacology
Vienna, State of Vienna, 1080
Reinhard Told, 01/40400/2988, reinhard.told@meduniwien.ac.at
Reinhard Told, MD
- Recruiting
Department of Gynecology
Vienna, State of Vienna, 1080
Harald Zeisler, Prof. MD, 01/40400 - 2881, harald.zeisler@meduniwien.ac.at
Harald Zeisler, Prof., MD
About this study
Official title: Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women
Maternal obesity, overweight and hypertensive disorders are among the most important risk factors for complications during pregnancy. Several lines of evidence indicate that overweight or obese women, as well as women with hypertensive disorders show increased risks of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic factor which allows for the early identifications of risk patients is still lacking. Recently, it has been reported that assessment of endothelial function may be a new promising tool for predicting the risk of adverse pregnancy outcome. As such evidence has been provided that endothelial dysfunction is prevalent among women with preeclampsia and is able to identify women at increased risk of preterm delivery and small-for-gestational-age (SGA) births. Several lines of evidence indicate that functional and structural changes of retinal vessels are altered in vascular related disease and may predict cardio-vascular events. Consequently, the current study seeks to investigate whether flicker induced vasodilatation, a well established parameter to test vascular function in-vivo is altered in women with low and high risk pregnancies when compared to a healthy control group. The data gained from this study may provide the basis for a larger longitudinal trial to assess whether vascular changes in the retina may predict the risk for complication during pregnancy.
- Conditions
- Pregnancy, High Risk Pregnancies
- Being tested
- Obstetrical care parameters, DVA measurements, Fundus photographs
- Keywords
- arteriovenous ratio, retinal flicker stimulation, Dynamic vessel analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetrical care parametersOther
DVA measurementsOther
Fundus photographsOther
| Study group | Role | What they receive |
|---|---|---|
| Low risk group | 40 subjects: Healthy, pregnant women Receives: Other: Obstetrical care parameters; Other: DVA measurements; Other: Fundus photographs | |
| High risk group | 40 pregnant women:
* 20 Pregnant women with preeclampsia
* 20 Obese pregnant women Receives: Other: Obstetrical care parameters; Other: DVA measurements; Other: Fundus photographs | |
| Healthy control subjects | 40 subjects Receives: Other: Obstetrical care parameters; Other: DVA measurements; Other: Fundus photographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
flicker-induced retinal vasodilatation
Measured: at inclusion, 3 Trimenon, post partum
Secondary outcomes (1)
adverse pregnancy outcome
Measured: post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald, Zeisler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340442
- Sponsor's protocol ID
- OPHT-060513
- Status last verified
- Aug 2015
- First submitted
- 13 Jan 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT02340442
- Acronym / sponsor ID
- OPHT-060513
- Conditions
- Pregnancy, High Risk Pregnancies
- Keywords
- arteriovenous ratio, retinal flicker stimulation, Dynamic vessel analyzer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 16 Jan 2015 (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.
Maternal obesity, overweight and hypertensive disorders are among the most important risk factors for complications during pregnancy. Several lines of evidence indicate that overweight or obese women, as well as women with hypertensive disorders show increased risks of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic factor which allows for the early identifications of risk patients is still lacking. Recently, it has been reported that assessment of endothelial function may be a new promising tool for predicting the risk of adverse pregnancy outcome. As such evidence has been provided that endothelial dysfunction is prevalent among women with preeclampsia and is able to identify women at increased risk of preterm delivery and small-for-gestational-age (SGA) births. Several lines of evidence indicate that functional and structural changes of retinal vessels are altered in vascular related disease and may predict cardio-vascular events. Consequently, the current study seeks to investigate whether flicker induced vasodilatation, a well established parameter to test vascular function in-vivo is altered in women with low and high risk pregnancies when compared to a healthy control group. The data gained from this study may provide the basis for a larger longitudinal trial to assess whether vascular changes in the retina may predict the risk for complication during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low risk group | – | Other: Obstetrical care parameters, Other: DVA measurements, Other: Fundus photographs40 subjects: Healthy, pregnant women |
| High risk group | – | Other: Obstetrical care parameters, Other: DVA measurements, Other: Fundus photographs40 pregnant women: * 20 Pregnant women with preeclampsia * 20 Obese pregnant women |
| Healthy control subjects | – | Other: Obstetrical care parameters, Other: DVA measurements, Other: Fundus photographs40 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited form the gynecology department and the department of clinical pharmacology
Key inclusion criteria (23 listed)
- • Age >18 years
- Systolic BP ≥140 mmHg, or diastolic BP ≥90 mmHg on at least 2 occasions AND
- Proteinuria (≥300 mg/day) after 20 weeks of gestation in preeclampsia
- Pregnant at the time of confirming diagnosis of preeclampsia
- Pre-pregnancy BMI ≥30 as assessed from medical history
Key exclusion criteria (10 listed)
- Diabetes mellitus type I or II
- Renal failure requiring dialysis
- Cirrhosis of liver
- Collagenosis
- Vasculitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetrical care parameters | Other | Healthy control subjects, High risk group, Low risk group |
| DVA measurements | Other | Healthy control subjects, High risk group, Low risk group |
| Fundus photographs | Other | Healthy control subjects, High risk group, Low risk group |
Primary outcome
flicker-induced retinal vasodilatation
Time frame: at inclusion, 3 Trimenon, post partum
1 secondary outcome
adverse pregnancy outcome
Time frame: post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and High Risk Pregnancies, run by Medical University of Vienna at 2 sites in Austria.
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 23 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald Zeisler, Prof. MD (01/40400 - 2881, harald.zeisler@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flicker-induced retinal vasodilatation (time frame: at inclusion, 3 Trimenon, post partum). 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 1 Sep 2015.