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Comparison of the effect of Aspirin at a dose of 160 mg per day with the usual dose of Aspirin (80 mg daily) in the prevention of preeclampsia in high-risk pregnant women

Protocol summary

Study aim
The aim of this study was to compare the effect of aspirin at a dose of 160 mg per day with the usual dose of aspirin (80 mg daily) in preventing preeclampsia in high-risk pregnant women referred to Mahdieh Hospital.
Design
In this randomized clinical trial, 216 pregnant women at 12-20 weeks of gestation with high risk of preeclampsia are selected. Patients are randomly assigned to one of the two groups of aspirin at a dose of 80 mg daily or the aspirin group at a dose of 160 mg daily and are treated for 36 weeks, respectively, based on a random number table.
Settings and conduct
In this randomized clinical trial, 216 pregnant women at 12-20 weeks of gestation with high risk of preeclampsia are selected. For the first group, aspirin at a dose of 80 mg per day and for the second group, aspirin at a dose of 160 mg per day were considered. This research is performed in Mahdieh Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria encompass age over 18 years, presence of high-risk factors for preeclampsia (e.g., multiplet pregnancy,history of preeclampsia or inappropriate consequences in previous pregnancies. Patients with a history of heart, liver, thyroid, bleeding disorders, peptic ulcer, asthma, aspirin sensitivity, the presence of major fetal disorders and long-term use of NSAIDs are also excluded from the study.
Intervention groups
This study has 2 intervention groups. For the first group, aspirin at a dose of 80 mg per day and for the second group, aspirin at a dose of 160 mg per day were considered.
Main outcome variables
Preeclampsia; IUGR; Premature birth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220410054469N1
Registration date: 2022-05-14, 1401/02/24
Registration timing: prospective

Last update: 2022-05-14, 1401/02/24
Update count: 0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Paria Panahinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3333 9458
Email address
drpanahinia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Aspirin at a dose of 160 mg per day with the usual dose of Aspirin (80 mg daily) in the prevention of preeclampsia in high-risk pregnant women
Public title
The effect of Aspirin in preventing preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women at 12-20 weeks of gestation at high risk for Preeclampsia.
Exclusion criteria:
Patients who find it difficult to follow a regular pattern of medication. Patients with heart, liver, thyroid, peptic ulcer diseases and bleeding disorder. Patients with a history of asthma, aspirin sensitivity, and the presence of major fetal disorders.
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 216
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of an individual using the rand function of EXCEL software. In this method, each person is assigned a number and based on software randomization, each person enters one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the researcher themselves were unaware of which control group (receiving the current routine drug, ie, 80 mg of aspirin daily) or intervention (receiving the dose of 80 mg of aspirin per day) belonged. For this purpose, patients in the control group are given two similar pills, one of which is a placebo.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Evin, Shahid Shahriari Square
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-01-22, 1400/11/02
Ethics committee reference number
IR.SBMU.MSP.REC.1400.689

Health conditions studied

1

Description of health condition studied
Pre-eclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia

Primary outcomes

1

Description
Incidence of Preeclampsia
Timepoint
From 12-20 to 36 weeks of pregnancy
Method of measurement
Mercury sphygmomanometer / laboratory abnormalities (including doubling of liver enzymes, doubling of serum creatinine and drop in platelets below 100,000)

Secondary outcomes

1

Description
Type of delivery (cesarean section or vaginal)
Timepoint
Time of delivery
Method of measurement
Based on medical file and disease progression

2

Description
Term or preterm delivery
Timepoint
Time of pregnancy termination
Method of measurement
Based on medical file and disease progression

Intervention groups

1

Description
Intervention group 1: Pregnant women in the 12-20 weeks of pregnancy who are at high risk of preeclampsia are treated with aspirin at a dose of 160 mg daily for 36 weeks. Aspirin tablets are provided by Sami Saz Company and are prescribed to patients. One 160 aspirin tablet is proscribed a day.
Category
Prevention

2

Description
Control group: Pregnant women who are prescribed aspirin 80 mg daily until the 36th week of pregnancy due to risk factors from 12-20 weeks of pregnancy. Aspirin 80 mg tablets are provided daily.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdiyeh Educational Hospital
Full name of responsible person
Paria Panahinia
Street address
Mahdieh Hospital, Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/index.jsp?siteid=110

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Web page address
https://en.sbmu.ac.ir/index.jsp?siteid=256&fkeyid=&siteid=24&pageid=13079&siteid=256
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Paria Panahinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdiyeh Hospital, Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
drpanahinia@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Paria Panahinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdiyeh Educational Hospital, Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Fax
Email
drpanahinia@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Paria Panahinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shishe Gar khaneh Alley, Fadaian Islam Ave, Shoosh Sq
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
drpanahinia@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
inclusion population and main outcome data
When the data will become available and for how long
Six months after the official release of the results
To whom data/document is available
Researchers, academics and industrial sectors
Under which criteria data/document could be used
The data will be used in meta-analysis research.
From where data/document is obtainable
Applicants can request the data by sending an email to Dr. Paria Panahinia. drpariapanahinia@yahoo.com
What processes are involved for a request to access data/document
While introducing themselves and explaining the need for access, data will be sent to them within 10 days to 1 month.
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