This is a randomized single blind clinical trial in preventing of preeclampsia and its complication in women with abnormal uterine Artery Doppler ultrasound. Inclusion criteria are included pregnant women in 16-18 week with preeclampsia risk such as: vascular disease, chronic hypertension, diabetes mellitus, age under 20 and more than 40 years old. Exclusion criteria are women with heart disease, liver disease, thyroid disease, chronic renal disease and peptic ulcer. Eighty women in 16-18 week of pregnancy that refers to the Shabihkhany hospital in kashan and had preeclampsia risk were selected. All underwent uterine Artery Doppler ultra sonography in 16-18 week and if results were abnormal they divided in two groups randomly. First group received 100 mg Aspirin tablet daily and second group didn't received any drug. Then all of patient visited every two week until beginning labor and checked their blood pressure. Then Pregnancy outcome include preeclampsia prevalence, IUGR, Preterm labor, Neonatal Apgar score at 1 and 5 minute, type of delivery, and neonatal weight will assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809232854N1
Registration date:2010-04-24, 1389/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Masoumeh Abedzadeh Kalahroudi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
abedzadeh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of resarch
Kashan University of Medical Sciences
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aspirin in prevention of pre eclampcia and its complication in women with abnormal uteirn Artery Doppler ultrasound
Public title
The effect of Aspirin in prevention of pre eclampcia and its complication in women with abnormal uteirn Artery Doppler ultrasound
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
pregnant women in 16-18 week with preeclampsia risk such as: vascular diseas,chronic hypertension, diabet melitus, age under 20 and more than 40 years old.
Exclusion criteria: women with heart disease, liver disease, thyroid disease, chronic renal disease and peptic ulcer.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravand Road Kashan University of Medical Sciences
City
Kashan
Postal code
Approval date
2010-03-17, 1388/12/26
Ethics committee reference number
5224/1/5/29/پ
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
014.9
ICD-10 code description
Pre-eclampsia, unspecified
Primary outcomes
1
Description
in prevention of pre eclampcia and its complication in women with abnormal uteirn Artery Doppler ultrasound
Timepoint
every two weeks
Method of measurement
patient visit and blood presure chek
Secondary outcomes
1
Description
delivery type
Timepoint
after delivery
Method of measurement
Documented data
2
Description
preterm labor
Timepoint
after delivery
Method of measurement
documented data
3
Description
neonatal Apgar score
Timepoint
1 and 5 minute after delivery
Method of measurement
heart rate, respiratory rate, tone,skin color and grimace
4
Description
neonatal weight
Timepoint
after delivery
Method of measurement
neonatal weight asses
5
Description
Intra uterine Growth Restriction
Timepoint
after delivery
Method of measurement
based on age and weight
Intervention groups
1
Description
Administration of 100 mg Aspirin tablet daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhany Hospital
Full name of responsible person
Dr Mesdaghinia Elahe
Street address
Beheshti Street ,Shabihkhany Hospital
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of resarch
Full name of responsible person
Dr Hamidy Gholamali
Street address
Ravand road Kashan University of Medical Sciences . Vice Chancellor of resarch
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of resarch
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
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Abedzadeh kalahroudi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Ravand road Kashan University of Medical Sciences Midwifery College - Midwifery Department
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
abedzadeh@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mesdaghinia Elahe
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Beheshti Street Shabihkhany Hospitak
City
Kashan
Postal code
Phone
+98 36 1446 0180
Fax
Email
Mesdaghiniaelaheh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Abedzadeh kalahroudi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Kashan University of Medical Sciences Midwifery College - Midwifery Department
City
Kashan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)