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The Impact of Myo- inositol supplementation to prevent gestational diabetes in overweight pregnant women

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History
# Registration date Revision Id
2 2019-09-16, 1398/06/25 107735
1 2017-12-14, 1396/09/23 29686
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  • Protocol summary

    In this study, 114 pregnant women with a gestational age of at least 14 weeks who are referred to the prenatal clinics of Rouhani and Yahya Nejad Hospitals are selected. The participants were divided With a block size of 4, into two groups of A and B (intervention and control) by selecting the number of (0 - 6) are randomly assigned using computer software.
    114 pregnant women who are referred to the obstetric clinics are selected. The participants were divided With a block size of 4, into two groups of A and B by selecting the number of (0 - 6) are randomly assigned.
    در این مطالعه ۱۱۴ خانم باردار با سن حاملگی حداقل ۱۴ هفته، از میان مراجعه کنندگان به درمانگاه های پره ناتال بیمارستان روحانی و یحیی نژاد انتخاب می شوند. شرکت کنندگان به روش بلوک ۴ تایی به دو گروه B و A (مداخله وکنترل)، با انتخاب عدد (۰ـ۶) به روش تصادفی با استفاده از نرم افزار کامپیوتری تقسیم می شوند.
    ۱۱۴ خانم باردار، از میان مراجعه کنندگان به درمانگاه های مامایی انتخاب می شوند. شرکت کنندگان به روش بلوک ۴ تایی به دو گروه B و A با انتخاب عدد (۰ـ۶) به روش تصادفی تقسیم می شوند.
    In this study, the participants, if the fasting glucose is less than 92 mg / dl or randomized glucose is less than 200, and other conditions for entry into the study are included. After describing the method of research and side effects of the drug and obtaining written consent, they are included in the study. Triglyceride, cholesterol, LDL, HDL, fasting blood sugar , fasting insulin, insulin sensitivity are checked according to routine laboratory tests and then them randomly divided into two groups. In group A( n = 57 ), people treated with myo-inositol supplementation powder containing 1000 mg of myo-inositol and 200 mcg of folic acid (manufactured by the company Lo.Li Pharma) once a day (one sachet dissolved in a glass of water every night) from the gestational age of (from 14 weeks to 24 weeks) and the group B ( n = 57 ) are received placebo once a day for a total of 10 weeks.
    The participants, if the fasting glucose is less than 92 mg / dl or randomized glucose is less than 200, and other conditions for entry into the study are included.Triglyceride, cholesterol, LDL, HDL, fasting blood sugar , fasting insulin, insulin sensitivity are checked according to routine laboratory tests and then them randomly divided into two groups. In group A (n = 30), people treated with myo-inositol of folic acid once a day from the gestational age of and the group B (n = 30) are received placebo.
    در این مطالعه شرکت کنندگان،در صورتیکه گلوکز ناشتا کمتر از 92 میلی گرم در دسی لیتر باشد یا گلوکز تصادفی کمتر از 200 باشد و شرایط دیگر ورود به مطالعه را نیز داشته باشند بعد از توضیح روش کار و عوارض دارو و اخذ رضایت کتبی وارد مطالعه می شوند. آزمایشات تری گلیسرید، کلسترول، LDL ، HDL، قند خون ناشتا، انسولین ناشتا، حساسیت به انسولین طبق روتین آزمایشگاهی بررسی می شود. سپس به طور تصادفی به دو گروه تقسیم می شوند در گروهA (57 نفر) افراد تحت درمان با پودر مکمل میواینوزیتول به اسم تجارتی اینوفولیک حاوی 2000 میلی گرم میواينوزيتول و 200 میکروگرم اسیدفولیک (ساخت شرکت سازنده Lo.Li Pharma) به صورت 1 بار در روز ( هرشب یک ساشه در یک لیوان آب حل شود) از سن بارداري 14هفته تا 24 هفته و گروه B (57 نفر) دارونما به صورت 1 بار در روز در مجموع به مدت 10 هفته دریافت می کنند.
    شرکت کنندگان،در صورتیکه گلوکز ناشتا کمتر از 92 میلی گرم در دسی لیتر باشد یا گلوکز تصادفی کمتر از 200 باشد و شرایط دیگر ورود به مطالعه را نیز داشته باشند. آزمایشات تری گلیسرید، کلسترول، LDL ، HDL، قند خون ناشتا، انسولین ناشتا، حساسیت به انسولین طبق روتین آزمایشگاهی بررسی می شود. سپس به طور تصادفی به دو گروه تقسیم می شوند در گروهA (30 نفر) افراد تحت درمان با میواینوزیتول و گروه B (30 نفر) دارونما به صورت 1 بار در روز دریافت می کنند.
    Inclusion criteria: Conscious written consent, pregnant women with singleton pregnancy, age above 18 years old, gestational age 14 weeks, per-pregnancy BMI >= 25 and less than 30 kg /m2, fasting glucose less than 92 mg /dL or Random glucose less than 200 mg /dL, no chronic diseases such as diabetes, high blood pressure and cardiovascular disease, non-smoking and alcohol. Exclusion criteria: The death experience of one of the first-degree relatives during pregnancy, Treatment with corticosteroids during pregnancy.
    Inclusion criteria: Written consent, pregnant women with singleton pregnancy, age above 18 years old, gestational age 14 weeks, per-pregnancy BMI >= 25 and less than 30 kg /m2, fasting glucose less than 92 mg /dL or Random glucose less than 200 mg /dL, no chronic diseases, non-smoking and alcohol. Exclusion criteria: The death experience of one of the first-degree relatives during pregnancy, treatment with corticosteroid during pregnancy.
    شرایط ورود:رضايت کتبی آگاهانه، خانم‌هاي باردار با حامگی تك قلو ، سن بالاتر از 18 سال، سن بارداري 14 هفته، شاخص توده بدن قبل از بارداری 25 و بیشتر و كمتر از 30 کیلوگرم/مترمربع، گلوکز ناشتا کمتر از 92 میلی گرم در دسی لیتر یا گلوکز تصادفی کمتر از 200 میلی گرم در دسی لیتر، عدم ابتلا به بيماري‌هاي جسمي مزمن مانند دیابت، فشار خون بالا و بیماری های قلبی عروقی، عدم مصرف سيگار و الكل شرایط خروج:تجربه‌ي مرگ يكي از بستگان درجه یک در طی بارداری، درمان با كورتون در طی بارداری
    شرایط ورود:رضايت کتبی آگاهانه، خانم‌هاي باردار با حامگی تك قلو ، سن بالاتر از 18 سال، سن بارداري 14 هفته، شاخص توده بدن قبل از بارداری 25 و بیشتر و كمتر از 30 کیلوگرم/مترمربع، گلوکز ناشتا کمتر از 92 میلی گرم در دسی لیتر یا گلوکز تصادفی کمتر از 200 میلی گرم در دسی لیتر، عدم ابتلا به بيماري‌هاي جسمي مزمن، عدم مصرف سيگار و الكل شرایط خروج:تجربه‌ي مرگ يكي از بستگان درجه یک در طی بارداری، درمان با كورتون در طی بارداری
    Intervention group: Myo-inositol supplementation powder the inofulic commercial name containing 2000 mg of myo-inositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day (one sachet dissolved in a glass of water every night) from the gestational age of 14 weeks to 24 weeks in Lo.Li Pharma Manufacturer company) for a total of 10 weeks. Control group: Placebo (folic acid powder 400 mcg + wheat flour total 1 grams) Once a day (one sachet dissolved in a glass of water every night) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks .
    Intervention group: Myo-inositol containing 2000 mg of myo-inositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day from the gestational age of 14 weeks to 24 weeks Control group: Placebo (folic acid powder 400 mcg + wheat flour total 2 grams) once a day from the gestational age 14 weeks to 24 weeks
    گروه مداخله : پودر مکمل میواینوزیتول به اسم تجارتی اینوفولیک حاوی 2000 میلی گرم میواينوزيتول و 200 میکروگرم اسیدفولیک (ساخت شرکت سازندهLo.Li Pharma) به صورت 1 بار در روز ( هرشب یک ساشه در یک لیوان آب حل شود از سن بارداري 14هفته تا 24 هفته درLo.Li Pharmaشرکت سازنده مجموع به مدت 10 هفته گروه كنترل: دارونما (پودر اسیدفولیک 400 میکروگرم + آرد گندم مجموع دو گرم) به صورت 1 بار در روز ( هرشب یک ساشه در یک لیوان آب حل شود) از سن بارداري 14هفته تا 24 هفته ) در مجموع به مدت 10 هفته
    گروه مداخله : میواینوزیتول حاوی 2000 میلی گرم میواينوزيتول و 200 میکروگرم اسیدفولیک (ساخت شرکت سازندهLo.Li Pharma) به صورت 1 بار در روز از سن بارداري 14هفته تا 24 هفته گروه كنترل: دارونما (پودر اسیدفولیک 400 میکروگرم + آرد گندم مجموع دو گرم) به صورت 1 بار در روز از سن بارداري 14هفته تا 24 هفته

  • General information

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    2017-12-05, 1396/09/14
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    2018-12-22, 1397/10/01
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    بازنگری اشکالات
    گروه های کور شده شامل: شرکت کننده، مراقب بالینی، محقق، ارزیابی کننده پیامد، آنالیزکننده داده می باشد. مطالعه از نوع دوسویه کور می باشد. داروها و پلاسبو توسط فرد دیگری غیر از محقق کد گذاری می شود به صورت گروه(2و1) و محقق اطلاعی ندارد که کدام گروه مربوط به دارو می باشد. از افراد مورد مطالعه رضایت گرفته میشود و به آن ها اطلاع داده می شود که ممکن است به جای دارو ، دارونما به آن ها داده شود.شیوه ی توزیع با تخصیص تصادفی،به روش بلوک های چهار تایی ، در یکی از دو گروه درمانی A و B با انتخاب اعداد تصادفی (0-6) با کمک نرم افزار کامپیوتری انجام می شود.
    گروه های کور شده شامل: شرکت کننده، مراقب بالینی، محقق، ارزیابی کننده پیامد، آنالیزکننده داده می باشد. مطالعه از نوع دوسویه کور می باشد. داروها و پلاسبو توسط فرد دیگری غیر از محقق کد گذاری می شود به صورت گروه (2و1) و محقق اطلاعی ندارد که کدام گروه مربوط به دارو می باشد. از افراد مورد مطالعه رضایت گرفته میشود و به آن ها اطلاع داده می شود که ممکن است به جای دارو ، دارونما به آن ها داده شود.شیوه ی توزیع با تخصیص تصادفی،به روش بلوک های چهار تایی ، در یکی از دو گروه درمانی A و B با انتخاب اعداد تصادفی (0-6) با کمک نرم افزار کامپیوتری انجام می شود.
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  • Recruitment centers

    #1
    Name of recruitment center - English: Prenatal Centers of Hospitals Affiliated to Babol University of Medical Sciences
    Name of recruitment center - Persian: مراکز پره ناتال بیمارستان های وابسته دانشگاه علوم پزشکی بابل
    Full name of responsible person - English: molood aghajani delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Street address - English: Babol University of Medical Sciences, GanjAfroz
    Street address - Persian: بابل، جاده گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone:
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:
    Name of recruitment center - English: Prenatal Centers of Hospitals Affiliated to Babol University of Medical Sciences
    Name of recruitment center - Persian: مراکز پره ناتال بیمارستان های وابسته دانشگاه علوم پزشکی بابل
    Full name of responsible person - English: Molood Aghajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Street address - English: Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
    Street address - Persian: ایران، استان مازندران، شهر بابل، جاده گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3236 0714
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Molood Aghajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Street address - English: Babol University of Medical Sciences
    Street address - Persian: دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone:
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Ali Bijani
    Full name of responsible person - Persian: علی بیژنی
    Street address - English: Babol University of Medical Sciences, GanjAfroz Avenue, Babol
    Street address - Persian: دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 1219 9592
    Fax:
    Email: alibijani@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Molood Aghajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Position - English: PhD in Womens Health
    Position - Persian: دکترای تخصصی بهداشت زنان
    Latest degree: phd
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
    Street address - Persian: ایران، مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3236 0714
    Mobile: +98 911 112 2866
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mouloud Agajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Position - English: PhD in Womens Health
    Position - Persian: دکترای تخصصی بهداشت زنان
    Latest degree: phd
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
    Street address - Persian: ایران، مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3236 0714
    Mobile: +98 911 112 2866
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Molood Aghajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Position - English: PhD in Womens Health
    Position - Persian: دکترای تخصصی بهداشت زنان
    Latest degree: phd
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
    Street address - Persian: ایران، مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3236 0714
    Mobile: +98 11 22866
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mouloud Agajani Delavar
    Full name of responsible person - Persian: مولود آقاجانی دلاور
    Position - English: PhD in Womens Health
    Position - Persian: دکترای تخصصی بهداشت زنان
    Latest degree: phd
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
    Street address - Persian: ایران، مازندران، بابل، خیابان گنج افروز، دانشگاه علوم پزشکی بابل
    City - English: Babol
    City - Persian: بابل
    Province: Mazandaran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۴۷۱۷۶-۴۷۷۴۵
    Phone: +98 11 3236 0714
    Mobile: +98 11 22866
    Fax:
    Email: moloodaghajani@yahoo.com
    Web page address:

  • Sharing plan

    empty
    There is no further information.
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    اطلاعات بیشتری وجود ندارد.

Protocol summary

Study aim
Determine the effect of myo_inositol supplementation to prevent gestational diabetes in overweight pregnant women.
Design
114 pregnant women who are referred to the obstetric clinics are selected. The participants were divided With a block size of 4, into two groups of A and B by selecting the number of (0 - 6) are randomly assigned.
Settings and conduct
The participants, if the fasting glucose is less than 92 mg / dl or randomized glucose is less than 200, and other conditions for entry into the study are included.Triglyceride, cholesterol, LDL, HDL, fasting blood sugar , fasting insulin, insulin sensitivity are checked according to routine laboratory tests and then them randomly divided into two groups. In group A (n = 30), people treated with myo-inositol of folic acid once a day from the gestational age of and the group B (n = 30) are received placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Written consent, pregnant women with singleton pregnancy, age above 18 years old, gestational age 14 weeks, per-pregnancy BMI >= 25 and less than 30 kg /m2, fasting glucose less than 92 mg /dL or Random glucose less than 200 mg /dL, no chronic diseases, non-smoking and alcohol. Exclusion criteria: The death experience of one of the first-degree relatives during pregnancy, treatment with corticosteroid during pregnancy.
Intervention groups
Intervention group: Myo-inositol containing 2000 mg of myo-inositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day from the gestational age of 14 weeks to 24 weeks Control group: Placebo (folic acid powder 400 mcg + wheat flour total 2 grams) once a day from the gestational age 14 weeks to 24 weeks
Main outcome variables
primary outcome: Gestational diabetes mellitus (Abnormal oral glucose tolerance test). Secondary outcomes: Neonatal and pregnancy outcomes and side effect of drug

General information

Reason for update
Revising sentence errors
Acronym
IRCT registration information
IRCT registration number: IRCT20160208026446N2
Registration date: 2017-12-14, 1396/09/23
Registration timing: registered_while_recruiting

Last update: 2019-10-15, 1398/07/23
Update count: 1
Registration date
2017-12-14, 1396/09/23
Registrant information
Name
Mouloud Agajani Delavar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 0714
Email address
m.aghajani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences,Governmental
Expected recruitment start date
2017-12-05, 1396/09/14
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Myo- inositol supplementation to prevent gestational diabetes in overweight pregnant women
Public title
The Impact of Myo- inositol supplementation to gestational diabetes in overweight pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious written consent Pregnant women with singleton pregnancy Age above 18 years old Gestational age 14 weeks Pr-pregnancy BMI>= 25 and less than 30 kg / m 2 Fasting glucose less than 92 mg / dL or Random glucose less than 200 mg / dL No chronic diseases such as diabetes, high blood pressure and cardiovascular disease Non-smoking and alcohol
Exclusion criteria:
The death experience of one of the first-degree relatives during pregnancy Treatment with corticosteroids during pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blind groups include: participant, clinical caregiver, researcher, outcome evaluator, data analyst. Double blind study. Medications and placebo are coded by someone other than the investigator as group (1 and 2) and the investigator do not know which group is related to the drug. The subjects are satisfied and informed that they may be Instead of medication, placebo is given to them. The distribution method With a block size of 4, for two groups (A, B). Random numbers (0 - 6) was generated using computer software.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic commitee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2017-08-20, 1396/05/29
Ethics committee reference number
MUBABOL.HRI.REC.1396.82

Health conditions studied

1

Description of health condition studied
Diabetes mellitus arising in pregnancy
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
Triglyceride
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

2

Description
Total cholesterol
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

3

Description
LDL
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

4

Description
HDL
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

5

Description
Fasting blood sugar
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

6

Description
Glucose tolerance test of 1 and 2 hours with 75 g of oral glucose
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

7

Description
Fasting insulin
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

8

Description
Insulin sensitivity
Timepoint
In the second trimester of the week( 24-28 )
Method of measurement
Testes based on laboratorial rutine( Detailed description in the proposal)

Secondary outcomes

1

Description
Neonatal and pregnancy outcomes
Timepoint
The end of pregnancy for the outcome of pregnancy and infancy
Method of measurement
Questionnaire and complete the checklist using patient file

2

Description
Side effect of drug
Timepoint
In the second trimester of pregnancy (week 24-28) and the third trimester of pregnancy (week 37_38)
Method of measurement
Drug side effect Checklist

Intervention groups

1

Description
Intervention group: Myoinositol supplementation powder the ino fulic commercial name containing 2000 mg of myoinositol and 200 μg of folic acid (manufactured by the company Lo.Li Pharma ) once a day(one sachet per night in a glass of water is dissolved)
Category
Prevention

2

Description
: Placebo (folic acid powder 400 mcg + wheat flour total 2 grams) Once a day (one hour a sachet is dissolved in a glass of water) from the gestational age 14 weeks to 24 weeks for a total of 10 weeks . Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Prenatal Centers of Hospitals Affiliated to Babol University of Medical Sciences
Full name of responsible person
Molood Aghajani Delavar
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3236 0714
Email
moloodaghajani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Babol University of Medical Sciences, GanjAfroz Avenue, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 1219 9592
Email
alibijani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Agajani Delavar
Position
PhD in Womens Health
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3236 0714
Fax
Email
moloodaghajani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Agajani Delavar
Position
PhD in Womens Health
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3236 0714
Fax
Email
moloodaghajani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Molood Aghajani Delavar
Position
Associated Prof. / Phd.
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
ایران
Phone
+98 11 3236 0714
Fax
Email
moloodaghajani@yahoo.com
Web page address

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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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