Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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The incidence of pre-eclampsia
General information
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Reason for update
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number of groups and participants has changed
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Acronym
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IRCT registration information
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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
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Registration date
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2018-12-26, 1397/10/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-11-22, 1398/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of two various aspirin dosage (80mg and 120mg daily) on prevention of pre-eclampsia in high risk pregnant women
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Public title
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Comparison of the effect of two doses of aspirin on the prevention of pre-eclampsia in high risk pregnant women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
729
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-23, 1397/08/01
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Ethics committee reference number
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IR.SBMU.MSP.REC.1397.531
Health conditions studied
1
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Description of health condition studied
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Preeclampsia
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ICD-10 code
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O14
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ICD-10 code description
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Pre-eclampsia
Primary outcomes
1
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Description
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The incidence of pre-eclampsia
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Timepoint
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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
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Method of measurement
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Blood pressure measurement and clinical examination
Secondary outcomes
1
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Description
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Gastrointestinal complications of aspirin (heartburn, gastrointestinal bleeding)
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Timepoint
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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
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Method of measurement
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Question from patient and clinical examination
2
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Description
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The incidence of intra-uterine growth retardation (IUGR)
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Timepoint
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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
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Method of measurement
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Clinical examination
3
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Description
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The incidence of preterm delivery
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Timepoint
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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
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Method of measurement
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Gestational age at delivery
4
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Description
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Vaginal bleeding as side effect of aspirin
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Timepoint
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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
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Method of measurement
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Question from patient and clinical examination
Intervention groups
1
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Description
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Intervention group: Daily oral aspirin (80mg)
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Daily oral aspirin (120mg)
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Category
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Treatment - Drugs
3
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Description
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Control group: Placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No need for publication
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available