In this double-blind randomized clinical trial, singleton pregnant women with gestational age between 11 to 15 weeks in prenatal clinic, Qazvin Kosar hospital are evaluated by uterine artery doppler sonography. Women with underlying disease, history of asthma, sensitivity to aspirin, termination of pregnancy before 20 weeks of gestation are excluded. One hundred pregnant women with abnormal findings in doppler sonography are randomly assigned to the intervention and control groups. Intervention group received aspirin 80 mg daily between 14 - 16 weeks of gestation until 37 weeks. The control group received a placebo pill daily. The two groups are followed until the end of pregnancy and pregnancy outcome in terms of preeclampsia, intrauterine growth restriction, preterm labor, mode of delivery, birth weight, first and fifth minutes apgar score are investigated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505103025N5
Registration date:2015-06-08, 1394/03/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Farideh Movahed
Name of organization / entity
Qazvin University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1335 0307
Email address
fmovahed@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aspirin adminstration for prevention of preeclampsia in pregnant women with abnormal findings in uterine artery doppler sonography
Public title
Effect of aspirin for prevention of preeclampsia in women with abnormal
ultrasonic findings in uterine artery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women; singletone; gestational age 11-15 weeks; abnormal finding in uterine artery doppler sonography
exclusion criteria: underlying medical condition; history of asthma; allergic to aspirin; termination of pregnancy before 20 weeks of pregnancy
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Qazvin University of Medical Sciences
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
Postal code
4321102589
Approval date
2014-06-12, 1393/03/22
Ethics committee reference number
28/20/8853
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O13
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria
2
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
Primary outcomes
1
Description
Preeclampsia
Timepoint
Measurement of Blood pressure every two weeks until 28 w then every week until termination of pregnancy
Method of measurement
Barometer, mmHg
Secondary outcomes
1
Description
Intrauterine Growth Retardation
Timepoint
Every two weeks until 28 w then every week until termination of pregnancy
Method of measurement
Doppler Ultrasound If fetal growth retardation is suspected
2
Description
1 and 5 min apgar
Timepoint
1 and 5 min after birth
Method of measurement
Standard apgar score
3
Description
Neonatal Weight
Timepoint
After Birth
Method of measurement
Digital Scale(gram)
Intervention groups
1
Description
Intervention Group: aspirine tablet 80 mili gram daily after 14-16 week of gestation until 37 week of pregnancy
Category
Prevention
2
Description
Control Group: placebo tablet daily after 14-16 week of gestation until 37 week of pregnancy
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Farideh Movahed
Street address
Iran,Qazvin, Taleghani St, Kosar Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Farideh Movahed
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Farideh Movahed
Position
Associate Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 33242661
Email
fmovahed@qums.ac.irdrmovahed@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Farideh Movahed
Position
Associate Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
Postal code
4321102589
Phone
+98 28 3333 6001
Fax
+98 33242661
Email
fmovahed@qums.ac.irdrmovahed@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)