Evaluation of the effect of aspirin administration on prevention of preeclampsia and fetal growth restriction in obese pregnant women
Design
This study is a randomized clinical trial that will be performed on 187 obese pregnant women referred to Yasuj Shahid Mofteh Clinic affiliated with Yasuj University of Medical Sciences in 2018-2019.
Settings and conduct
Intervention group: Aspirin, one dose of aspirin 1 mg daily until 34 weeks of preganncy was used.
Control group: placebo was used one day until 34 weeks of pregnancy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-40
Single pregnancy
Tends to participate in the study
Non underlying known disease such as chronic hypertension, liver disease, kidney disease, diabetes mellitus
No using aspirin or allergy history
BMI≥30
No ultrasound findings On NT, mean PI Ut>1.5 or PAPPA <0.4
No history of previous preeclampsia
No history of previous fetal growth restriction
Normality of tests and screening
Exclusion criteria:
Unwillingness to participate in study Not available for evaluations Abortion and preterm delivery for reasons other than preeclampsia and fetal growth restriction
Intervention groups
Aspirin compared to placebo
Main outcome variables
Preeclamsia, fetal growth restriction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160524028038N5
Registration date:2019-10-02, 1398/07/10
Registration timing:registered_while_recruiting
Last update:2019-10-02, 1398/07/10
Update count:0
Registration date
2019-10-02, 1398/07/10
Registrant information
Name
Fatemeh Bazarganipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
bazarganipour@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aspirin on the incidence of preeclampsia and fetal growth restriction in obese pregnant women
Public title
Aspirin and preeclampsia and fetal growth restriction in obese pregnant Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-40
Single pregnancy
Tends to participate in the study
Non underlying known disease such as chronic hypertension, liver disease, kidney disease, diabetes mellitus
No using aspirin or allergy history
BMI≥30
No ultrasound findings On NT, mean PI Ut>1.5 or PAPPA <0.4
No history of previous preeclampsia
No history of previous fetal growth restriction
Normality of tests and screening
Exclusion criteria:
Unwillingness to participate in study
Not available for evaluations
Abortion and preterm delivery for reasons other than preeclampsia and fetal growth restriction
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. The sealed envelopes encoded and non-transparent (A and B) for the allocation of subjects to intervention (A) and control (B) groups will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, kohgiluyeh and boyer-ahmad
City
yasuj
Postal code
7916839319
Approval date
2019-02-16, 1397/11/27
Ethics committee reference number
IR.YUMS.REC.1397.152
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14.0
ICD-10 code description
Mild to moderate pre-eclampsia
2
Description of health condition studied
Fetal growth restriction
ICD-10 code
P05.1
ICD-10 code description
Newborn small for gestational age
Primary outcomes
1
Description
Preeclamsia
Timepoint
End of pregnancy
Method of measurement
questionnaire
Secondary outcomes
1
Description
Fetal growth retardation
Timepoint
End of pregnancy
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: Take one dose of aspirin 80 mg daily until 34 weeks of gestation
Category
Treatment - Drugs
2
Description
Control group: Take one dose of placebo daily until 34 weeks of gestation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yasuj University of Medical Sciences
Full name of responsible person
Maryam Sadeghian
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Kohgiluyeh and Boyer-Ahmad
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.sadeghiyan64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari-Oriad
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.sadeghiyan64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Sadeghian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.sadeghiyan64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Sadeghian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.sadeghiyan64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maryam Sadeghian
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 7916839319, Shahid Jalil Ave., Yasuj Town, Kohgiluyeh and Boyer-Ahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7916839319
Phone
+98 74 3333 7251
Email
dr.sadeghiyan64@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD