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DVA Risk Pregnancy

Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02340442
Enrollment
120
Registered
2015-01-16
Start date
2013-10-31
Completion date
Unknown
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Pregnancies, Pregnancy

Keywords

arteriovenous ratio, retinal flicker stimulation, Dynamic vessel analyzer

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.

Interventions

OTHERObstetrical care parameters
OTHERDVA measurements
OTHERFundus photographs

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
flicker-induced retinal vasodilatationat inclusion, 3 Trimenon, post partum

Secondary

MeasureTime frame
adverse pregnancy outcomepost partum

Countries

Austria

Contacts

Primary ContactHarald Zeisler, Prof. MD
harald.zeisler@meduniwien.ac.at01/40400 - 2881

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026