Comparison of Aspirin dose (80 and 160 mg) in prevention of preeclampsia and maternal fetal complications
Design
A controlled clinical trial, with parallel groups, randomized
Settings and conduct
This randomized clinical trial will be conducted in Shahid Akbarabadi Medical Center in 1398. Simple sampling will be done from pregnant women with gestational age of 12 to 16 weeks who referred to the hospital's prenatal clinic would be selected based on inclusion criteria. Samples will be randomly assigned to two groups (each group of 40): the group receiving aspirin 80 mg and the group receiving aspirin 160 mg. Demographic characteristics including age, body mass index, pregnancy number, systolic and diastolic blood pressure were recorded at the first visit. Pregnant mothers will be visited every two weeks until gestational age of 28 weeks and after that will be visited weekly until the termination of pregnancy.
Participants/Inclusion and exclusion criteria
Pregnant women at 12 to 16 weeks of gestation referring to the prenatal clinic of Shahid Akbarabadi Hospital have at least one of the following conditions:
Previous history of preeclampsia, chronic hypertension, type 1 and type 2 diabetes, kidney disease, autoimmune disease,
Or have at least two of the following conditions:
nulliparity, obesity, over 35 years old, low socioeconomic status, Pregnancy interval over 10 years, history of stillbirth
Intervention groups
Intervention group 1: Pregnant women receiving 80 mg aspirin.
Intervention group II: Pregnant women receiving 160 mg aspirin.
Main outcome variables
preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190826044619N1
Registration date:2020-02-04, 1398/11/15
Registration timing:retrospective
Last update:2020-02-04, 1398/11/15
Update count:0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Maryam Chamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8856 2080
Email address
chamani.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Aspirin dose (80 and 160 mg) in prevention of preeclampsia and maternal fetal complications
Public title
Comparison of Aspirin dose in prevention of preeclampsia and maternal fetal complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The pregnant mother has completed the consent form to participate in the study.
Pregnant mother is 12 to 16 weeks pregnant.
The pregnant mother has at least one of the following criteria: a history of previous preeclampsia, polygamy, chronic hypertension, type 1 and type 2 diabetes, kidney disease, autoimmune disease (such as lupus). Or the pregnant mother has at least two of the following criteria: nulliparity, obesity, age over 35, low level of socioeconomic status, gap between pregnancies over 10 years, adverse pregnancy outcome (stillbirth, etc.)
Exclusion criteria:
The pregnant mother has peptic ulcer.
The pregnant mother has gout.
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into study groups based on random allocation rule (each group of 40) . Forty sample will be selected randomly by lottery method from the entire sample, and assigned to the 80 mg aspirin group and the remaining sample assigned to the 160 mg aspirin 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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.IUMS.FMD.REC.1398.133
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
Each 2 week from 20 to 28 weeks of gestational age and after that weekly until the termination of pregnancy.
Method of measurement
Systolic blood pressure greater than 1 mmHg or diastolic blood pressure greater than 1 mmHg
Secondary outcomes
1
Description
Preterm delivery
Timepoint
Mother's delivery
Method of measurement
Maternal gestational age is less than 37 weeks.
2
Description
Method of childbirth
Timepoint
Mother's delivery
Method of measurement
Cesarean section or Vaginal delivery
3
Description
Intrauterine fetal growth restriction
Timepoint
Every two weeks from the start of the intervention until the 28th week of pregnancy
Method of measurement
sonography
4
Description
Apgar score minute1
Timepoint
1 minute after birth
Method of measurement
Grading to Appearance, Pulse, Grimace, Activity and Respiration of baby
5
Description
Apgar score minute 5
Timepoint
5 minutes after birth
Method of measurement
Grading to Appearance, Pulse, Grimace, Activity and Respiration of baby
Intervention groups
1
Description
Intervention group: Pregnant women who will take aspirin 160 mg.The 80 mg Aspirin by the Jalinus Pharmaceutical Company will be used orally 2 times a day from the time of study until the end of the 36th week of pregnancy.
Category
Treatment - Drugs
2
Description
control group: Pregnant women who will take aspirin 80 mg.The 80 mg Aspirin by the Jalinus Pharmaceutical Company will be used orally once a day from the time of study until the end of the 36th week of pregnancy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Perinatal clinic of Shahid Akbarabadi hospital
Full name of responsible person
Maryam Chamani
Street address
Bagh Ferdows Station., Mowlavi St
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Chamani
Street address
Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8856 2080
Email
chamani.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Chamani
Position
َAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
1st Floor, Unit 6, Pearl Complex, North Motahhari St, Darya Boulevard, Saadat Abad Ave.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 8856 2080
Email
chamani.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Chamani
Position
َAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
1st Floor, Unit 6, Pearl Complex, North Motahhari St, Darya Boulevard, Saadat Abad Ave.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 8856 2080
Email
chamani.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Chamani
Position
َAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
1st Floor, Unit 6, Pearl Complex, North Motahhari St, Darya Boulevard, Saadat Abad Ave.
City
Tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 8856 2080
Email
chamani.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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