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Protocol summary
Among patients with GDM referred to Beheshti gynecology Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Among patients with GDM referred to Shahid Beheshti gynecology and obstetrics Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Among patients with GDM referred to Shahid Beheshti gynecology and obstetrics Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any supplements 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, Smokers, and Unwillingness to cooperate.
Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any antioxidant agents 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, and Unwillingness to cooperate.
Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any supplementsantioxidant agents 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, Smokers, and Unwillingness to cooperate.
معیار ورود به مطالعه: زنان مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: دیابت شیرین آشکار، مصرف هر نوع مکمل 3 ماه قبل از مداخله، نیاز به درمان با انسولین، کم کاری و یا پر کاری تیروئید، سیگاری ها، عدم تمایل به همکاری.
معیار ورود به مطالعه: زنان مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: دیابت شیرین آشکار، مصرف هر نوع مکمل آنتی اکسیدان 3 ماه قبل از مداخله، نیاز به درمان با انسولین، کم کاری و یا پر کاری تیروئید، عدم تمایل به همکاری.
معیار ورود به مطالعه: زنان مبتلا به دیابت بارداری در محدوده سنی 18 تا 40 سال. معیار عدم ورود به مطالعه: دیابت شیرین آشکار، مصرف هر نوع مکمل آنتی اکسیدان 3 ماه قبل از مداخله، نیاز به درمان با انسولین، کم کاری و یا پر کاری تیروئید، سیگاری ها، عدم تمایل به همکاری.
Intervention group: Tab N-acetylcysteine 600 mg three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally. Control group: Tab Placebo three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
IIntervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
InterventionIIntervention group: Tab N-acetylcysteine 600 mg three times a dayTablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Control group: Tab Placebo three times a daytablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران) برای 6 هفته به صورت خوراکی. گروه کنترل: قرص دارونما، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران) برای 6 هفته
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین(شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی. گروه کنترل: قرص دارونما (شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین، 3 بار در روز (شرکتسیستئین(شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی. گروه کنترل: قرص دارونما، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
General information
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The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
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پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Overt diabetes mellitus
Taking any supplements 3 months before the intervention
Needing insulin therapy
Hypo and hyperthyroidism
Smokers
Unwillingness to cooperate
Overt diabetes mellitus
Taking any antioxidant agents 3 months before the intervention
Needing insulin therapy
Hypo and hyperthyroidism
Unwillingness to cooperate
Overt diabetes mellitus Taking any supplementsantioxidant agents 3 months before the intervention Needing insulin therapy Hypo and hyperthyroidism Smokers Unwillingness to cooperate
دیابت آشکار
مصرف هر نوع مکمل 3 ماه قبل از مداخله
نیاز به درمان با انسولین
کم کاری و یا پر کاری تیروئید
سیگاری ها
عدم تمایل به ادامه همکاری.
دیابت آشکار
مصرف هر نوع مکمل آنتی اکسیدان 3 ماه قبل از مداخله
نیاز به درمان با انسولین
کم کاری و یا پر کاری تیروئید
عدم تمایل به ادامه همکاری.
دیابت آشکار مصرف هر نوع مکمل آنتی اکسیدان 3 ماه قبل از مداخله نیاز به درمان با انسولین کم کاری و یا پر کاری تیروئید سیگاری ها عدم تمایل به ادامه همکاری.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک زنان بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده داروها را تخصیص خواهد داد. داروها و پلاسبو ها در شرکت داروسازی اسوه در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود.بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک زنان شهید بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده داروها را تخصیص خواهد داد. داروها و پلاسبو ها در شرکت داروسازی اسوه در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود.بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک زنان شهید بهشتی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده داروها را تخصیص خواهد داد. داروها و پلاسبو ها در شرکت داروسازی اسوه در بسته بندی های مشابه قرار می گیرند و بر روی آنها فقط کد گذاشته می شود.بیمار و محقق از نوع مداخله بی خبرند و بعد از آنالیز داده ها، کدهای بسته ها رمز گشایی میشود. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند.
Secondary outcomes
#1
Newborn's head circumference
Cesarean section rate
Newborn's head circumferenceCesarean section rate
دور سر نوزادان
درصد زایمان سزارین
دور سر نوزاداندرصد زایمان سزارین
Tape
checklist
Tapechecklist
متر نواری
چک لیست
متر نواریچک لیست
#2
Newborn's weight
Preterm delivery
Newborn's weightPreterm delivery
وزن نوزادان
زایمان زودرس
وزن نوزادانزایمان زودرس
Scale
checklist
Scalechecklist
ترازو
چک لیست
ترازوچک لیست
#3
Newborn length
Pre-eclampsia rate
Newborn lengthPre-eclampsia rate
قد نوزاد
میزان پره اکلامپسی
قد نوزادمیزان پره اکلامپسی
The first 24 h after birth
During intervention
The first 24 h after birthDuring intervention
ساعت اول بعد از تولد
در طول مداخله
ساعت اول بعد از تولددر طول مداخله
Girth measuring tape
checklist
Girth measuring tapechecklist
متر نواری
چک لیست
متر نواریچک لیست
#4
empty
Macrosomia rate
Macrosomia rate
empty
درصد ماکروزومی
درصد ماکروزومی
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
checklist
checklist
empty
چک لیست
چک لیست
#5
empty
Low birth weight
Low birth weight
empty
ورن کم موقع تولد
ورن کم موقع تولد
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
checklist
checklist
empty
چک لیست
چک لیست
#6
empty
Newborns’ hyperbilirubinemia
Newborns’ hyperbilirubinemia
empty
بیلی روبینمی نوزاد
بیلی روبینمی نوزاد
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
checklist
checklist
empty
چک لیست
چک لیست
#7
empty
Newborns’ hospitalization
Newborns’ hospitalization
empty
میزان بستری شدن نوزاد
میزان بستری شدن نوزاد
empty
Delivery time
Delivery time
empty
زمان زایمان
زمان زایمان
empty
checklist
checklist
empty
چک لیست
چک لیست
Intervention groups
#1
Intervention group: Tab N-acetylcysteine 600 mg three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
Intervention group: Tab N-acetylcysteine 600 mg three times a dayTablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران) برای 6 هفته به صورت خوراکی.
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین(شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
گروه مداخله: قرص 600 میلی گرم ان استیل سیستئین، 3 بار در روز (شرکتسیستئین(شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
#2
Control group: Tab Placebo three times a day (Osve Pharmaceutical Co., Tehran, Iran), for 6 weeks orally.
Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
Control group: Tab Placebo three times a daytablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
گروه کنترل: قرص دارونما، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران) برای 6 هفته
گروه کنترل: قرص دارونما (شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
گروه کنترل: قرص دارونما، 3 بار در روز (شرکت داروسازی اسوه، تهران، ایران)، 1 بار در روز برای 6 هفته به صورت خوراکی.
Recruitment centers
#1
Name of recruitment center - English: Beheshti Gynecology Clinic
Name of recruitment center - Persian: کلینیک بهشتی
Full name of responsible person - English: Dr. Zohreh Tabasi
Full name of responsible person - Persian: دکتر زهره طبسی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: Tabasi.z@gmail.com
Web page address:
Name of recruitment center - English: Gynecology and Obstetrics Clinic of Shahid Beheshti Hospital
Name of recruitment center - Persian: کلینیک زنان و زایمان بیمارستان شهید بهشتی
Full name of responsible person - English: Dr. Zohreh Tabassi
Full name of responsible person - Persian: دکتر زهره طبسی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Fax:
Email: tabassiz@yahoo.com
Web page address:
Name of recruitment center - English: Gynecology and Obstetrics Clinic of Shahid Beheshti Gynecology ClinicHospital Name of recruitment center - Persian: کلینیک زنان و زایمان بیمارستان شهید بهشتی Full name of responsible person - English: Dr. Zohreh TabasiTabassi Full name of responsible person - Persian: دکتر زهره طبسی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Fax: Email: Tabasi.ztabassiz@gmail.comyahoo.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: Dr. Susan Asadpour
Full name of responsible person - Persian: دکتر سوزان اسدپور
Position - English: Resident of gynecology and obstetrics
Position - Persian: رزیدنت بیماری های زنان و زایمان
Latest degree: med_doctor
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 31 5546 3378
Fax:
Email: Asadpou.s@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Susan Assadpour
Full name of responsible person - Persian: دکتر سوزان اسدپور
Position - English: Resident of gynecology and obstetrics
Position - Persian: رزیدنت بیماری های زنان و زایمان
Latest degree: med_doctor
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 31 5546 3378
Fax:
Email: susanassadpour67@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Susan AsadpourAssadpour Full name of responsible person - Persian: دکتر سوزان اسدپور Position - English: Resident of gynecology and obstetrics Position - Persian: رزیدنت بیماری های زنان و زایمان Latest degree: med_doctor Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 31 5546 3378 Fax: Email: Asadpou.ssusanassadpour67@gmail.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: Dr. Zohreh Tabasi
Full name of responsible person - Persian: دکتر زهره طبسی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: Tabasi.z@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Zohreh Tabassi
Full name of responsible person - Persian: دکتر زهره طبسی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: tabassiz@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Zohreh TabasiTabassi Full name of responsible person - Persian: دکتر زهره طبسی Position - English: Associate Professor Position - Persian: دانشیار Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: Tabasi.ztabassiz@gmail.comyahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Zohreh Tabasi
Full name of responsible person - Persian: دکتر زهره طبسی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: Tabasi.z@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Zohreh Tabassi
Full name of responsible person - Persian: دکتر زهره طبسی
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: tabassiz@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Zohreh TabasiTabassi Full name of responsible person - Persian: دکتر زهره طبسی Position - English: Associate Professor Position - Persian: دانشیار Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: Tabasi.ztabassiz@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with GDM.
Design
Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive N-acetyl cystein (n=38) or placebo (n=38).
Settings and conduct
Among patients with GDM referred to Shahid Beheshti gynecology and obstetrics Clinic affiliated to Kashan University of Medical Sciences, 76 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Drugs and placebos are similar. Fasting blood samples will be taken at baseline and 6 weeks after the intervention. At the beginning and the end of the intervention: 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with gestational diabetes aged 18 to 40 years. Exclusion criteria: Overt diabetes mellitus, taking any antioxidant agents 3 months before the intervention, needing insulin therapy, Hypo and hyperthyroidism, and Unwillingness to cooperate.
Intervention groups
IIntervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally. Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
Main outcome variables
Outcomes: Insulin resistance (primary outcome) and lipid profiles, biomarkers of inflammation and oxidative stress, and pregnancy outcomes (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N71
Registration date:2020-04-21, 1399/02/02
Registration timing:registered_while_recruiting
Last update:2021-01-16, 1399/10/27
Update count:1
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of N-acetylcysteine administration on pregnancy outcomes and metabolic profiles in women with gestational diabetes mellitus
Public title
Effects of N-acetylcysteine administration in treatment of women with gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational diabetes mellitus.
Individuals aged 18 to 40 years.
Exclusion criteria:
Overt diabetes mellitus
Taking any antioxidant agents 3 months before the intervention
Needing insulin therapy
Hypo and hyperthyroidism
Unwillingness to cooperate
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 76 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Gynecology Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. Drugs and placebos are in the same packaging at the Osve pharmaceutical company. Only the code is written on the packages. Patients and researcher will not know the type of drug. After analyzing the data, packet codes will be decoded. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.126
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Unspecified diabetes mellitus in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Calculation using HOMA formula
Secondary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
2
Description
Total cholesterol
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
HDL
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Hs-CRP
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Elisa kit
6
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
7
Description
Glutathione
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
8
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 6 weeks of intervention
Method of measurement
Spectrophotometry
9
Description
Cesarean section rate
Timepoint
Delivery time
Method of measurement
checklist
10
Description
Preterm delivery
Timepoint
Delivery time
Method of measurement
checklist
11
Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonography
12
Description
Pre-eclampsia rate
Timepoint
During intervention
Method of measurement
checklist
13
Description
Macrosomia rate
Timepoint
Delivery time
Method of measurement
checklist
14
Description
Low birth weight
Timepoint
Delivery time
Method of measurement
checklist
15
Description
Newborns’ hyperbilirubinemia
Timepoint
Delivery time
Method of measurement
checklist
16
Description
Newborns’ hospitalization
Timepoint
Delivery time
Method of measurement
checklist
Intervention groups
1
Description
Intervention group: N-acetylcysteine 600 mg Tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo tablet (Osve Pharmaceutical Co., Tehran, Iran), once a day, for 6 weeks orally.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Obstetrics Clinic of Shahid Beheshti Hospital
Full name of responsible person
Dr. Zohreh Tabassi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
tabassiz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
banafshe.hr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Susan Assadpour
Position
Resident of gynecology and obstetrics
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
susanassadpour67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabassi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
tabassiz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Zohreh Tabassi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
tabassiz@yahoo.com
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
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