The aim of this study was to evaluate the effect of myoinositol on gestational diabetes in high risk women.
Design
This is a randomized, multi-center, clinical trial with parallel groups. Our sample size is 276 people.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: family history of type 2 diabetes, previous history of GDM, glucosoria, glucose metabolism disorder and a history of infant macrosomia.
Intervention groups
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.
Main outcome variables
the rate of gestational diabetes and other side effects of gestational diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120826010664N4
Registration date:2019-05-08, 1398/02/18
Registration timing:registered_while_recruiting
Last update:2019-05-08, 1398/02/18
Update count:1
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Reihaneh Pirjani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3288
Email address
pirjani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of myoinositol supplementation on the prevention of gestational diabetes mellitus in high-risk women
Public title
The effect of myoinositol supplementation on the prevention of gestational diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
276
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Tehran University of Medical Sciences , Deputy of Research
Street address
Qods Street, Keshavarz Bulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1101
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus (GDM)
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
gestational diabetes mellitus
Timepoint
24- 28 weeks of pregnancy
Method of measurement
glucose tolerance test
Secondary outcomes
1
Description
type of delivery
Timepoint
end of pregnancy
Method of measurement
observational
2
Description
Macrosomia
Timepoint
After child birth
Method of measurement
observational
3
Description
preterm labor
Timepoint
end of pregnancy
Method of measurement
observational
4
Description
Preeclampsia
Timepoint
end of pregnancy
Method of measurement
observational
5
Description
premature rupture of membranes (PROM)
Timepoint
end of pregnancy
Method of measurement
observational
6
Description
Intrauterine growth restriction (IUGR)
Timepoint
end of pregnancy
Method of measurement
observational
Intervention groups
1
Description
Intervention group: 2 gr of myoinositol plus 200 micro gr folic acid twice a day orally, from 14th week of gestation until 28th week.
Category
Treatment - Drugs
2
Description
Control group: 200 micro gr folic acid twice a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr Reyhaneh Pirjani
Street address
Eastern 162th St.,Baghdarnia st.,Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
pirjani@Razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Laleh Eslamian
Street address
Jalal-e-Al-e-Ahmad Hwy, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
leslamian@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Tehran University of Medical Science, Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
2
Sponsor
Name of organization / entity
Health Parsian
Full name of responsible person
Dr Melina Makhmour Najafabadi
Street address
No. 492, Unit 16, Dowlat St, Pasdaran St, Teharn, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2259 0539
Fax
+98 21 2257 6449
Email
info@healthparsian.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Health Parsian
Proportion provided by this source
99
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihaneh Pirjani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihaneh Pirjani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
pirjani@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Reihaneh Pirjani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3288
Fax
+98 21 7788 3196
Email
pirjani@razi.tums.ac.ir
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 decision yet.
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