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Clinical Trials/NCT02340442
NCT02340442
Unknown
Not Applicable

Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women

Medical University of Vienna2 sites in 1 country120 target enrollmentOctober 2013

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (2)

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