The aim of this study is to evaluate the effect of Aspirin on endothelial dysfunction in preeclamptic patients. Pregnancy and suffering from preeclampsia are inclusion criteria and patients with major underlying disease and who consumed drug incompletely, will be excluded from the study. Eighty five patients are divided randomly into two groups. Aspirin 80 mg or placebo will be taken daily by oral administration from the initiation of diagnosis until 2 months after delivery by the trial participant. Every patient’s Flow Mediated Dilation will be evaluated at the beginning of study and 2 months after delivery with the same experienced operator at a same period of the time (3-5 p.m.) by High resolution B-mode ultrasonographic.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040527135N2
Registration date:2016-06-04, 1395/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
Registrant information
Name
Saeide Bahrani
Name of organization / entity
Isfahn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 435 0474
Email address
isrc_info@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low dose Aspirin on endothelial dysfunction in preeclamptic patients
Public title
Effect of aspirin on prevention of preeclamsia consequences
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnancy; preeclampsia
Exclusion criteria: Major underlying diseases; incomplete drug consumption
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahn University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
ir.mui.rec.1394.3.649
Health conditions studied
1
Description of health condition studied
Pre-eclampsia
ICD-10 code
O14.9
ICD-10 code description
Pre-eclampsia, unspecified
Primary outcomes
1
Description
flow mediated dilation of brachial artery
Timepoint
before and after intervention
Method of measurement
High resolution B-mode ultrasonographic
Secondary outcomes
1
Description
lipid profile
Timepoint
before and after intervention
Method of measurement
laboratory test
Intervention groups
1
Description
asprin, tablet, 80 mg, oral, from the initiation of diagnosis until 2 months after delivery
Category
Treatment - Drugs
2
Description
placebo, tablet, 80 mg, oral, daily, from the initiation of diagnosis until 2 months after delivery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
St-zahra Educational Hospital
Full name of responsible person
Forouz Baktash
Street address
Isfahan University of Medical Sciences, Hezar jarib St, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mrs Eshghi
Street address
Isfahan University of Medical Sciences, Hezar jarib St, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Forouz Baktash
Position
Cardiovascular resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
saeide.bahrani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Kian Heshmat
Position
cardiology resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3333 3333
Fax
Email
kiyan-heshmat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahn University of Medical Sciences
Full name of responsible person
Forouz Basktash
Position
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
saeide.bahrani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)