Comparison of the effect of 80 and 150 mg aspirin on maternal and fetal factors in first trimester of pregnancy in women who is high risk for preeclampsia in patients referred to teaching hospitals of Shiraz University of Medical Sciences
Comparison of the effect of 80 and 150 mg aspirin on maternal and fetal factors in first trimester of pregnancy in women who is high risk for preeclampsia in patients referred to teaching hospitals of Shiraz University of Medical Sciences
Design
In our research, we will select 100 high risk pregnant women for preterm labor based on first trimester doppler sonography, then with block randomizing method we will place them on two groups. 50 patient will receive 80 mg aspirin and other group will receive 100 mg aspirin. Treatment starts since 11-13 week of pregnancy until 34 week or delivery time.
Settings and conduct
Between all pregnant women who will come to educational hospital in Shiraz city until 21/3/2021, 100 person who are high risk for preterm labor based on first trimester doppler ultrasonography will be selected and they will be assigned in two groups with bloc randomizing method. 50 patients will receive 80 mg aspirin and the other will receive 100 mg aspirin. Finally the results between two groups will be compared .it needs to be mentioned that all tablets will be used in two groups have the same shape ,color and size. . The nurse of research center has the list of randomized and grouping and tablets, and she will give drugs to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: singleton pregnant women who are at high risk for uteroplacental ischemia and preterm labor according to increased uterine artery resistant in first trimester doppler ultrasonography. Exclusion criteria: multiple pregnancy; fetal aneuploidy; fetal anomaly; coagulation disorder; allergy to aspirin; women who use aspirin or heparin before starting study.
Intervention groups
50 person will receive 80 mg aspirin and the other 50 person will receive 150 mg aspirin.
Main outcome variables
Decrease fetal mortality and morbidity due to severe preeclamsia & GDM
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140317017035N7
Registration date:2020-11-28, 1399/09/08
Registration timing:prospective
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 80 and 150 mg aspirin on maternal and fetal factors in first trimester of pregnancy in women who is high risk for preeclampsia in patients referred to teaching hospitals of Shiraz University of Medical Sciences
Public title
Effect of Aspirin on on maternal and fetal factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The singleton pregnant women who are high risk for uteroplacental preeclamsia and GDM based on increased uterine artery resistant on first trimester doppler ultarasonography.
Exclusion criteria:
Multiple pregnancy
Fetal aneuploidy
Fetal anomaly
Coagulation disorder
Allergy to aspirin
Women who use aspirin or heparin before starting study
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In our research, we will select 100 high risk pregnant women for preterm severe preeclamsia & GDM based on first trimester doppler sonography, then with block randomizing method with 4th and 6th block, we will place them on two groups. 50 patient will receive 80 mg aspirin and other group will receive 150 mg aspirin. Treatment starts since 11-13 week of pregnancy until 34 week or delivery time(each one occur sooner.)
Blinding (investigator's opinion)
Double blinded
Blinding description
All tablet use in two groups are the same shape, color and size. Patients and doctors are unaware about dosages that is chosen in each person. The nurse of research center has the list of randomized and grouping and tablets and she will give drugs to the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Cmmittee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
Headquarters Of Shir
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.SUMS.MED.REC.1398.642
Health conditions studied
1
Description of health condition studied
Severe preeclampsia
ICD-10 code
JA24
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Decrease fetal mortality and morbidity due to preeclampsia
Timepoint
َAfter birth
Method of measurement
Vital Signs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 person will receive 80 mg aspirin untill 34 weeks
Category
Treatment - Drugs
2
Description
Intervention group: 50 person will receive 150 mg aspirin untill 34 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez hospital of Shiraz University of Medical Sciences
Full name of responsible person
Syedeh Fateme Khaleghi
Street address
Hafez Hospital; Shahid Chamran blvd
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
alifatijoon1396@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sydeh Fateme Khaleghi
Position
Resident of obstetrics and gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3233 2365
Email
alifatijoon1396@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
maryamkasraeian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasreian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
maryamkasraeian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD: Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2020Ethic form: 2020
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document