DVA Risk Pregnancy

August 31, 2015 updated by: Harald, Zeisler, Medical University of Vienna

Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1080
        • Recruiting
        • Department of Clinical Pharmacology
        • Contact:
        • Sub-Investigator:
          • Reinhard Told, MD
      • Vienna, Austria, 1080
        • Recruiting
        • Department of Gynecology
        • Contact:
        • Principal Investigator:
          • Harald Zeisler, Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited form the gynecology department and the department of clinical pharmacology

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low risk group
40 subjects: Healthy, pregnant women
Other: Obstetrical care parameters
Other: DVA measurements
Other: Fundus photographs
High risk group

40 pregnant women:

  • 20 Pregnant women with preeclampsia
  • 20 Obese pregnant women
Other: Obstetrical care parameters
Other: DVA measurements
Other: Fundus photographs
Healthy control subjects
40 subjects
Other: Obstetrical care parameters
Other: DVA measurements
Other: Fundus photographs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse pregnancy outcome
Time Frame: post partum
post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPHT-060513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe