Comparison of the effect of Aspirin at doses of 80 and 160 mg on the prevention of preeclampsia in women with abnormal Doppler ultrasound of the uterine artery
Comparison of the effectiveness of aspirin with doses of 80 and 160 mg on the prevention of preeclampsia in women with abnormal Doppler ultrasound of the uterine artery
Design
This study includes two groups of intervention and control, which were divided into two groups of 150 people using a randomization table.
Settings and conduct
This study will be performed as a three-blind study in Sabzevar Medical Sciences Clinic in all women with impaired uterine artery Doppler. The patient and the assistant researcher and statistical analyst are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant mothers 18-22 weeks with abnormal uterine artery Doppler
Exclusion criteria: Lack of cooperation and unwillingness of the mother to continue the plan, preterm delivery for reasons other than blood pressure
Intervention groups
Intervention group 1: Daily consumption of 80 mg of aspirin
Intervention group 2: Daily consumption of 160 mg of aspirin
Main outcome variables
Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210804052071N1
Registration date:2022-03-03, 1400/12/12
Registration timing:registered_while_recruiting
Last update:2022-03-03, 1400/12/12
Update count:0
Registration date
2022-03-03, 1400/12/12
Registrant information
Name
Mahboobeh Nikanjam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 8100
Email address
nikanjam_dr@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Aspirin at doses of 80 and 160 mg on the prevention of preeclampsia in women with abnormal Doppler ultrasound of the uterine artery
Public title
Comparison of the effect of Aspirin at doses of 80 and 160 mg on the prevention of preeclampsia in women with abnormal Doppler ultrasound of the uterine artery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers at 18 to 22 weeks with impaired uterine artery Doppler
Being single
Exclusion criteria:
Premature birth for reasons other than blood pressure
The mother's unwillingness to continue cooperating
Not taking the right medication
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
atients with the above conditions in two groups are randomly entered into one of the two intervention or control groups by blocking method (quadruple blocks). Thus, various quadrilateral blocks were created (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks will be randomly selected and patients will be divided into one of two groups A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The way of participant blindness is that she will receive and use a certain number of drugs in an unnamed and labeled envelopes.The investigators, participants, and evaluators will be blinded to assignment into the two groups (the groups taking the ASA+ ASA or taking the ASA+ placebo).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Mobini Haspital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.MEDSAB.REC.1400.128
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Preeclampsia
Timepoint
During pregnancy up to 40 days after delivery
Method of measurement
Mercury sphygmomanometer, urine test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women who will take aspirin 80 mg. Aspirin 80 mg from Galenus Pharmaceutical Company will be taken orally once a day from the time of enrollment until the end of pregnancy.
Category
Treatment - Drugs
2
Description
Intervention group: Pregnant women who will take aspirin 160 mg. Aspirin 80 mg from Galenus Pharmaceutical Company will be taken orally 2 times a day from the time of enrollment until the end of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Eftekhari Yazdi
Street address
Kashefi St, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Phone
+98 51 4423 8100
Email
m_eftekhari1144@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Eftekhari Yazdi
Street address
Kashefi St, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Phone
+98 51 4423 8100
Email
m_eftekhari1144@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Eftekhari Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashefi St, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Phone
+98 51 4423 8100
Email
m_eftekhari1144@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Eftekhari Yazdi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashefi St., Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Phone
+98 51 4423 8100
Email
m_eftekhari1144@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mitra Eftekhari Yazdi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashefi St, Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9313856776
Phone
+98 51 4423 8100
Email
m_eftekhari1144@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
A piece of data such as information about the main outcome or the possibility of sharing.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Necessary conditions for sending a request for access to the data or documents of the plan approval form in medical universities.
From where data/document is obtainable
The request for data will be sent via email and will be answered within a week after review.
What processes are involved for a request to access data/document
The request for data will be sent via email and will be answered within a week after review.