Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- Medical University of Vienna
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- flicker-induced retinal vasodilatation
- Last Updated
- 10 years ago
Overview
Brief 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. 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.
Investigators
Harald, Zeisler
Prof. Dr.
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •• 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:
- •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:
Exclusion Criteria
- •Diabetes mellitus type I or II
- •Renal failure requiring dialysis
- •Cirrhosis of liver
- •Collagenosis
- •Vasculitis
- •Paraproteinaemia
- •Alcohol abuse
- •Amyloidosis
- •Clinical signs of polyneuropathy
- •Any other clinical finding, unless the clinical investigator considers a finding to be non clinically significant.
Outcomes
Primary Outcomes
flicker-induced retinal vasodilatation
Time Frame: at inclusion, 3 Trimenon, post partum
Secondary Outcomes
- adverse pregnancy outcome(post partum)