DVA Risk Pregnancy

• Conditions: Pregnancy; High Risk Pregnancies
• Interventions: Other: Obstetrical care parameters; Other: DVA measurements; Other: Fundus photographs

• Registration Number: NCT02340442
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low risk group	Fundus photographs	40 subjects: Healthy, pregnant women
Healthy control subjects	Fundus photographs	40 subjects
Low risk group	Obstetrical care parameters	40 subjects: Healthy, pregnant women
Low risk group	DVA measurements	40 subjects: Healthy, pregnant women
High risk group	Obstetrical care parameters	40 pregnant women: * 20 Pregnant women with preeclampsia * 20 Obese pregnant women
High risk group	DVA measurements	40 pregnant women: * 20 Pregnant women with preeclampsia * 20 Obese pregnant women
High risk group	Fundus photographs	40 pregnant women: * 20 Pregnant women with preeclampsia * 20 Obese pregnant women
Healthy control subjects	DVA measurements	40 subjects
Healthy control subjects	Obstetrical care parameters	40 subjects

Primary Outcome Measures

Name	Time	Method
flicker-induced retinal vasodilatation	at inclusion, 3 Trimenon, post partum

Secondary Outcome Measures

Name	Time	Method
adverse pregnancy outcome	post partum

Trial Locations

Locations (2)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria

Department of Gynecology; 🇦🇹 Vienna, Austria