DVA Risk Pregnancy

• Register: ClinicalTrials.gov
• Last refreshed on: 14 September 2015
• Main ID: NCT02340442
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: DVA Risk Pregnancy
• Scientific title: Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women
• Date of first enrolment: October 2013
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02340442
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Harald Zeisler, Prof. MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy

High Risk Pregnancies

Intervention(s)

Other: DVA measurements

Other: Fundus photographs

Other: Obstetrical care parameters

Primary Outcome(s)

flicker-induced retinal vasodilatation [Time Frame: at inclusion, 3 Trimenon, post partum]

Secondary Outcome(s)

adverse pregnancy outcome [Time Frame: post partum]

Secondary ID(s)

OPHT-060513

Source(s) of Monetary Support

Please refer to primary and secondary sponsors