Clinical trial NCT02340442: DVA Risk Pregnancy
Official title: Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
High Risk Pregnancies
Keywords: arteriovenous ratio
retinal flicker stimulation
Dynamic vessel analyzer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited form the gynecology department and the department of clinical pharmacology

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.


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:

• 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.

Primary outcomes:
measure: flicker-induced retinal vasodilatation
timeFrame: at inclusion, 3 Trimenon, post partum
Secondary outcomes:
measure: adverse pregnancy outcome
timeFrame: post partum
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology
city: Vienna
country: Austria
facility: Department of Gynecology
Study officials:
References: