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Protocol summary
In this clinical trial, 464 pregnant women older than 18 years of age eligible for the study are randomly assigned into two groups of 80 mg or 120 mg daily oral aspirin, according to the random number table.
In this clinical trial, 729 pregnant women older than 18 years of age eligible for the study are randomly assigned into two groups of 80 mg or 120 mg daily oral aspirin, according to the random number table.
In this clinical trial, 464729 pregnant women older than 18 years of age eligible for the study are randomly assigned into two groups of 80 mg or 120 mg daily oral aspirin, according to the random number table.
در این کارآزمایی بالینی، تعداد 464 زن حامله بالاتر از 18 سال واحد شرایط به ترتیب ورود و بر اساس جدول اعداد تصادفی بطور تصادفی به دو گروه درمان روزانه با آسپیرین خوراکی 80mg یا 120mg تقسیم می شوند.
در این کارآزمایی بالینی، تعداد 729 زن حامله بالاتر از 18 سال واحد شرایط به ترتیب ورود و بر اساس جدول اعداد تصادفی بطور تصادفی به دو گروه درمان روزانه با آسپیرین خوراکی 80mg یا 120mg تقسیم می شوند.
در این کارآزمایی بالینی، تعداد 464729 زن حامله بالاتر از 18 سال واحد شرایط به ترتیب ورود و بر اساس جدول اعداد تصادفی بطور تصادفی به دو گروه درمان روزانه با آسپیرین خوراکی 80mg یا 120mg تقسیم می شوند.
Aspirin 80mg Group: Daily intake of oral aspirin (80mg) from enterence to the study up to delivery time
Aspirin 120mg Group: Daily intake of oral aspirin (120mg) from enterence to the study up to delivery time
Aspirin 80mg Group: Daily intake of oral aspirin (80mg) from entrance to the study up to delivery time
Aspirin 120mg Group: Daily intake of oral aspirin (120mg) from entrance to the study up to delivery time
Control group: Placebo
Aspirin 80mg Group: Daily intake of oral aspirin (80mg) from enterenceentrance to the study up to delivery time Aspirin 120mg Group: Daily intake of oral aspirin (120mg) from enterenceentrance to the study up to delivery time Control group: Placebo
گروه آسپیرین 80mg: مصرف روزانه 80mg آسپیرین خوراکی از زمان مراجعه تا زایمان
گروه آسپیرین 120mg: مصرف روزانه 120mg آسپیرین خوراکی از زمان مراجعه تا زایمان
گروه آسپیرین 80mg: مصرف روزانه 80mg آسپیرین خوراکی از زمان مراجعه تا زایمان
گروه آسپیرین 120mg: مصرف روزانه 120mg آسپیرین خوراکی از زمان مراجعه تا زایمان
گروه کنترل : دارونما
گروه آسپیرین 80mg: مصرف روزانه 80mg آسپیرین خوراکی از زمان مراجعه تا زایمان گروه آسپیرین 120mg: مصرف روزانه 120mg آسپیرین خوراکی از زمان مراجعه تا زایمان گروه کنترل : دارونما
General information
464
729
464729
empty
number of groups and participants has changed
number of groups and participants has changed
empty
تغییر تعداد گروه ها و نمونه ها
تغییر تعداد گروه ها و نمونه ها
A 22-by-22 table, which is randomly generated by the computer and contains numbers from 1 to 484, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the aspirin 80mg group and even numbers are assigned to the aspirin 120mg group.
A 22-by-22 table, which is randomly generated by the computer and contains numbers from 1 to 729, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the aspirin 80mg group and even numbers are assigned to the aspirin 120mg group.
A 22-by-22 table, which is randomly generated by the computer and contains numbers from 1 to 484729, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the aspirin 80mg group and even numbers are assigned to the aspirin 120mg group.
از یک جدول ۲۲ در ۲۲ که بصورت تصادفی توسط کامپیوتر تولید شده و حاوی اعداد 1 تا ۴۸۴ می باشد استفاده می شود. انتخاب نمونه از خانه اول در بالا و چپ شروع شده و در جهت چپ به راست و بالا به پایین ادامه می یابد. اعداد فرد به گروه آسپیرین ۸۰mg و اعداد زوج به گروه آسپیرین ۱۲۰mg تخصیص می یابند.
از یک جدول ۲۲ در ۲۲ که بصورت تصادفی توسط کامپیوتر تولید شده و حاوی اعداد 1 تا 729 می باشد استفاده می شود. انتخاب نمونه از خانه اول در بالا و چپ شروع شده و در جهت چپ به راست و بالا به پایین ادامه می یابد. اعداد فرد به گروه آسپیرین ۸۰mg و اعداد زوج به گروه آسپیرین ۱۲۰mg تخصیص می یابند.
از یک جدول ۲۲ در ۲۲ که بصورت تصادفی توسط کامپیوتر تولید شده و حاوی اعداد 1 تا ۴۸۴729 می باشد استفاده می شود. انتخاب نمونه از خانه اول در بالا و چپ شروع شده و در جهت چپ به راست و بالا به پایین ادامه می یابد. اعداد فرد به گروه آسپیرین ۸۰mg و اعداد زوج به گروه آسپیرین ۱۲۰mg تخصیص می یابند.
Intervention groups
#1
empty
Placebo
placebo
empty
Control group: Placebo
Control group: Placebo
empty
گروه کنترل: دارو نما
گروه کنترل: دارو نما
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Ali Ziayee
Full name of responsible person - Persian: دکتر علی ضیایی
Street address - English: Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
Street address - Persian: بزرگراه شهید چمران، خیابان یــمن، خیابان شهید اعــرابی، جنب بیمارستان آیت الله طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717443
Phone: +98 21 23871
Fax:
Email: info@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Ali Ziayee
Full name of responsible person - Persian: دکتر علی ضیایی
Street address - English: Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
Street address - Persian: بزرگراه شهید چمران، خیابان یــمن، خیابان شهید اعــرابی، جنب بیمارستان آیت الله طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717443
Phone: +98 21 2243 9780
Fax:
Email: Mpajouhesh@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Ali Ziayee Full name of responsible person - Persian: دکتر علی ضیایی Street address - English: Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway Street address - Persian: بزرگراه شهید چمران، خیابان یــمن، خیابان شهید اعــرابی، جنب بیمارستان آیت الله طالقانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717443 Phone: +98 21 238712243 9780 Fax: Email: infoMpajouhesh@sbmu.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of two various doses of aspirin (80mg and 120mg daily) on preventing pre-eclampsia in high risk pregnant women referred to Mahdieh Hospital
Design
In this clinical trial, 729 pregnant women older than 18 years of age eligible for the study are randomly assigned into two groups of 80 mg or 120 mg daily oral aspirin, according to the random number table.
Settings and conduct
Pregnant women admitted to Mahdieh Hospital in Tehran, who are at high risk of pre-eclampsia and eligible for the study, are selected and randomly assigned to either 80mg or 120mg daily oral aspirin treatment group and treated up to 36 weeks. Participants will be visited monthly up to 28 weeks and every two weeks thereafter. In each visit, in addition to measuring blood pressure, the participants will be asked about the drug complications. All patients are carefully monitored for pregnancy outcomes such as pre-eclampsia, IUGR, and preterm delivery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women over 18 years of age, gestational age of 12-20 weeks, high risk factors for pre-eclampsia (such as multiple pregnancy, chronic hypertension, diabetes mellitus type 1 or 2, chronic kidney disease, autoimmune disease (antiphospholipid syndrome, lupus), history of pre-eclampsia or bad outcomes in previous pregnancies and the presence of a viable fetus
Exclusion criteria: Cardiovascular, liver, thyroid, hemorrhagic or peptic ulcer disease, history of asthma, sensitivity to aspirin , major fetal disorders, and long-term use of NSAIDs
Intervention groups
Aspirin 80mg Group: Daily intake of oral aspirin (80mg) from entrance to the study up to delivery time
Aspirin 120mg Group: Daily intake of oral aspirin (120mg) from entrance to the study up to delivery time
Control group: Placebo
Main outcome variables
The incidence of pre-eclampsia
General information
Reason for update
number of groups and participants has changed
Acronym
IRCT registration information
IRCT registration number:IRCT20120918010876N6
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2023-10-09, 1402/07/17
Update count:1
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Masumeh Mirza Moradi
Name of organization / entity
Prinatalogy department of Mahdieh hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5506 6263
Email address
m-bakhtiyari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two various aspirin dosage (80mg and 120mg daily) on prevention of pre-eclampsia in high risk pregnant women
Public title
Comparison of the effect of two doses of aspirin on the prevention of pre-eclampsia in high risk pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women over 18 years of age
Gestational age of 12-20 weeks
High risk factors for pre-eclampsia (such as multiple pregnancy, chronic hypertension, diabetes mellitus type 1 or 2 , chronic kidney disease, autoimmune disease (antiphospholipid syndrome, lupus)
History of pre-eclampsia or bad outcomes in previous pregnancies
The presence of a viable fetus
Exclusion criteria:
Existence of Cardiovascular, liver, thyroid, hemorrhagic or peptic ulcer diseases
History of asthma
Sensitivity to aspirin
Major fetal disorders
Prolonged use of NSAIDs
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
729
Randomization (investigator's opinion)
Randomized
Randomization description
A 22-by-22 table, which is randomly generated by the computer and contains numbers from 1 to 729, is used. Selecting a sample starts at the first cell from top and left of the table and goes left to right and up to down. Odds numbers are assigned to the aspirin 80mg group and even numbers are assigned to the aspirin 120mg group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.SBMU.MSP.REC.1397.531
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
The incidence of pre-eclampsia
Timepoint
Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time
Method of measurement
Blood pressure measurement and clinical examination
Secondary outcomes
1
Description
Gastrointestinal complications of aspirin (heartburn, gastrointestinal bleeding)
Timepoint
Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time
Method of measurement
Question from patient and clinical examination
2
Description
The incidence of intra-uterine growth retardation (IUGR)
Timepoint
Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time
Method of measurement
Clinical examination
3
Description
The incidence of preterm delivery
Timepoint
Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time
Method of measurement
Gestational age at delivery
4
Description
Vaginal bleeding as side effect of aspirin
Timepoint
Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time
Method of measurement
Question from patient and clinical examination
Intervention groups
1
Description
Intervention group: Daily oral aspirin (80mg)
Category
Treatment - Drugs
2
Description
Intervention group: Daily oral aspirin (120mg)
Category
Treatment - Drugs
3
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Masoome Mirzamoradi
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh-haspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Ali Ziayee
Street address
Next to Taleghani Hospital, Shahid Arabi St., Yemen St., Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
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
Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
mahdie hospital- shoosh sq- -tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoome Mirzamoradi
Position
Perinatologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdieh Hospital, Shoosh Sq.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 6263
Fax
Email
drmoradi000@yahoo.com
Web page address
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
No need for publication
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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