Protocol summary
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Study aim
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To compare the effectiveness of aspirin and aspririn metformin combination preventing preeclampsia in high risk pregnant women with abnormal ultrasonic findings in uterine artery
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Design
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In our research,we will select161high risk pregnant women for preclampsia based on first trimester Doppler sonography,then with block randomizing method we will place them on two groups.161patient will receive aspirin& Metformin and other group will receive aspirin&placebo.Treatment starts since11-13week of pregnancy until34 week or delivery time.
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Settings and conduct
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Between all pregnant women who will come to educational hospital in Shiraz city,322 person who are high risk based on first trimester Doppler sono will be selected and they will be assigned in two groups with block randomizing method.Group1will receive aspirin&metformin and the other will receive aspirin&placebo.Finally the results between two groups will be compared.It needs to be mentioned that all tablets will be used in two groups have the same shape ,color and size.The staff of research center has the list of randomized and grouping and tablets,and she will give drugs to the patients.
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Participants/Inclusion and exclusion criteria
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The singleton pregnant women who are high risk for utero-placental ischemia according to increased uterine artery resistant in first trimester Doppler sono.Exclusion criteria:Multiple pregnancy;Fetal aneuploidy;Fetal anomaly;Coagulation disorder;Allergy to aspirin
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Intervention groups
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Group A patients are prescribed two Aspirin 80 tablets made by Jalinous Pharmaceutical Company and two placebo tablets(placebo will be made by the Faculty of Pharmacy of SUMS)and for Group B two Aspirin80 tablets made by Jalinous Pharmaceutical Company and two Metformin tablets of500ml are prescribed.
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Main outcome variables
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Prevention of preclampsia and decrease fetal mortality and morbidity due to preclampsia
General information
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Reason for update
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correction some words
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140317017035N9
Registration date:
2024-05-18, 1403/02/29
Registration timing:
prospective
Last update:
2024-05-23, 1403/03/03
Update count:
1
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Registration date
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2024-05-18, 1403/02/29
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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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2024-05-21, 1403/03/01
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Expected recruitment end date
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2025-01-20, 1403/11/01
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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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To compare the effectiveness of aspirin and aspririnmetformin combination preventing preeclampsia in high risk pregnant women with abnormal ultrasonic findings in uterine artery a randomized clinical trial
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Public title
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Effectiveness of aspirin and aspririnmetformin combination preventing preeclampsia
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
The singleton pregnant women who are high risk for uteroplacental ischemia and preclampsia based on increased uterine artery resistant on first trimester doppler ultarasonography.
Exclusion criteria:
Multiple pregnancy
Fetal aneuploidy
Fetal anomaly
Allergy to aspirin
Women who use aspirin or heparin before starting study
Coagulation disorder
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Age
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From 18 years old to 45 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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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
322
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In our research ,we will select 322 high risk pregnant women for preeclampsia based on first trimester doppler sonography ,then with block randomizing method we will place them on two groups. 161 patient will receive aspirin & pelacbo and other group will receive Metformine & aspirin .treatment starts since 11-13 week of pregnancy until 34 week or delivery time(each one occur sooner.)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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All tablet use in two groups are the same shape , color and size. Patients and doctors are unaware about dosages that is choosed in each person. The nurse of research center has the list of randomized and grouping and tablets and she will give drugs to the patients.
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Placebo
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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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2024-04-13, 1403/01/25
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Ethics committee reference number
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IR.SUMS.REC.1403.047
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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Decrease fetal mortality and morbidity due to preeclampsia
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Timepoint
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After birth
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Method of measurement
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Vital Signs
Intervention groups
1
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Description
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Intervention group: Aspirin 160 mg and metformin 1000 mg
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Category
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Treatment - Drugs
2
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Description
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Control group: Aspirin with a dose of 160 mg and 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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Shiraz 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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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2024و Ethic form: 2024
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To whom data/document is available
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IPD: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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IPD: Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery Ethic form: Vice chancellery
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Comments
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