NCT02340442

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

January 13, 2015

Last Update Submit

August 31, 2015

Conditions

PregnancyHigh Risk Pregnancies

Keywords

arteriovenous ratioretinal flicker stimulationDynamic vessel analyzer

Outcome Measures

Primary Outcomes (1)

  • flicker-induced retinal vasodilatation

    at inclusion, 3 Trimenon, post partum

Secondary Outcomes (1)

  • adverse pregnancy outcome

    post partum

Study Arms (3)

Low risk group

40 subjects: Healthy, pregnant women

Other: Obstetrical care parametersOther: DVA measurementsOther: Fundus photographs

High risk group

40 pregnant women: * 20 Pregnant women with preeclampsia * 20 Obese pregnant women

Other: Obstetrical care parametersOther: DVA measurementsOther: Fundus photographs

Healthy control subjects

40 subjects

Other: Obstetrical care parametersOther: DVA measurementsOther: Fundus photographs

Interventions

Obstetrical care parametersOTHER
Healthy control subjectsHigh risk groupLow risk group
DVA measurementsOTHER
Healthy control subjectsHigh risk groupLow risk group
Fundus photographsOTHER
Healthy control subjectsHigh risk groupLow risk group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)
  • +8 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical Pharmacology

Vienna, Vienna, 1080, Austria

RECRUITING

Department of Gynecology

Vienna, Vienna, 1080, Austria

RECRUITING

Central Study Contacts

Harald Zeisler, Prof. MD

CONTACT

01/40400 - 2881harald.zeisler@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

AU(2)