Protocol summary
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Study aim
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The aim of this study was to evaluate the effect of myoinositol on gestational diabetes in high risk women.
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Design
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This is a randomized, multi-center, clinical trial with parallel groups. Our sample size is 276 people.
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Settings and conduct
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This randomized trial will be conducted on 276 eligible women, attending to Shariati and Arash hospitals. Fasting blood glucose and oral glucose tolerance test (GTT 75gm) and HbA1c tests will be performed for all women and they will be randomly divided into two groups. All participants will be tested again for GTT 75gm in 24- 28 gestational weeks. Then they will be followed up to the end of the pregnancy.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria are: family history of type 2 diabetes, previous history of GDM, glucosoria, glucose metabolism disorder and a history of infant macrosomia.
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Intervention groups
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Group 1 will receive 2 gr of myoinositol plus 200 micro gr of folic acid, twice a day orally from the 14th week of gestation until the 28th week. The second group will receive 200 micro gr folic acid twice a day orally.
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Main outcome variables
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the rate of gestational diabetes and other side effects of gestational diabetes
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120826010664N4
Registration date:
2019-05-08, 1398/02/18
Registration timing:
registered_while_recruiting
Last update:
2024-08-17, 1403/05/27
Update count:
1
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Registration date
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2019-05-08, 1398/02/18
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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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Tehran University of Medical Science
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Expected recruitment start date
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2019-02-20, 1397/12/01
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Expected recruitment end date
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2020-05-21, 1399/03/01
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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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The effect of myoinositol supplementation on the prevention of gestational diabetes mellitus in high-risk women
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Public title
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The effect of myoinositol supplementation on the prevention of gestational diabetes mellitus
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
BMI>30
Family history of type 2 diabetes
Previous history of GDM
Glucosoria
Glucose metabolism disorder
history of infant macrosomia
Exclusion criteria:
History of diabetes mellitus
Multiple pregnancy
Acute infection during pregnancy
Impaired GTT in first-trimester routine tests
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Age
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No age limit
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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:
276
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Our sample size is 276, with 138 participants in each group. Given the multi-central design of the study, 138 patients in each center will be selected according to the following manner. We have two randomization lists with a length of 138 (69 participants in each group) that the number of treatments in each list is equal, with a 1:1 ratio. Block randomization method will be designed by the head epidemiologist using STATA software version 13. The number of blocks considered is 6.
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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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2019-10-01, 1398/07/09
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.618
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes mellitus (GDM)
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ICD-10 code
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O24.4
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ICD-10 code description
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Gestational diabetes mellitus
Primary outcomes
1
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Description
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gestational diabetes mellitus
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Timepoint
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24- 28 weeks of pregnancy
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Method of measurement
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glucose tolerance test
Secondary outcomes
1
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Description
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type of delivery
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Timepoint
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end of pregnancy
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Method of measurement
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observational
2
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Description
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Macrosomia
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Timepoint
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After child birth
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Method of measurement
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observational
3
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Description
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preterm labor
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Timepoint
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end of pregnancy
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Method of measurement
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observational
4
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Description
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Preeclampsia
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Timepoint
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end of pregnancy
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Method of measurement
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observational
5
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Description
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premature rupture of membranes (PROM)
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Timepoint
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end of pregnancy
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Method of measurement
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observational
6
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Description
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Intrauterine growth restriction (IUGR)
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Timepoint
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end of pregnancy
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Method of measurement
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observational
Intervention groups
1
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Description
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Intervention group: 2 gr of myoinositol plus 200 micro gr folic acid twice a day orally, from 14th week of gestation until 28th week.
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Category
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Treatment - Drugs
2
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Description
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Control group: 200 micro gr folic acid twice a day.
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Category
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Treatment - Drugs
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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Tehran University of Medical Sciences
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Proportion provided by this source
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1
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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
2
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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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Health Parsian
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Proportion provided by this source
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99
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Public or private sector
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Private
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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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Industry
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 decision yet.
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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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available