DVA Risk Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women

Conditions
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Pregnancy, High Risk Pregnancies

Intervention / Treatment
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* Other: Obstetrical care parameters
* Other: DVA measurements
* Other: Fundus photographs


Participation Criteria
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Eligibility Criteria
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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: • 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low risk group<br>40 subjects: Healthy, pregnant women | Other: Obstetrical care parameters<br> <br> Other: DVA measurements<br> <br> Other: Fundus photographs<br> <br> |
| High risk group<br>40 pregnant women: 20 Pregnant women with preeclampsia 20 Obese pregnant women | Other: Obstetrical care parameters<br> <br> Other: DVA measurements<br> <br> Other: Fundus photographs<br> <br> |
| Healthy control subjects<br>40 subjects | Other: Obstetrical care parameters<br> <br> Other: DVA measurements<br> <br> Other: Fundus photographs<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flicker-induced retinal vasodilatation |  | at inclusion, 3 Trimenon, post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse pregnancy outcome |  | post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteriovenous ratio, retinal flicker stimulation, Dynamic vessel analyzer