DVA Risk Pregnancy

Pregnancy Clinical Trial

Official title:

Retinal Vessel Analysis in Low Risk and High Risk Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02340442
• Other study ID #: OPHT-060513
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2015
• Last updated: August 31, 2015
• Start date: October 2013

Study information

• Verified date: August 2015
• Source: Medical University of Vienna
• Contact: Harald Zeisler, Prof. MD
• Phone: 01/40400 - 2881
• Email: harald.zeisler[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• High Risk Pregnancies
• Pregnancy

Intervention

Other:
• Obstetrical care parameters

• DVA measurements

• Fundus photographs

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna
Austria	Department of Gynecology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flicker-induced retinal vasodilatation		at inclusion, 3 Trimenon, post partum	No
Secondary	adverse pregnancy outcome		post partum	No