Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
This study will be conducted in two parts: in the first stage thyroid hormones are tested in 1600 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody are identified. Three times urine during a week are also sampled for iodine measurement. Women with TPOAb negative (more than 50 kIU/l) and TSH between 2.5 and 10 mIU/ liter in the first 20 weeks of pregnancy, will enter into the second phase of the study. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly (based on the odd or even sample code) into two groups. The first group, intervention group, is treated with levothyroxine. The second group, control group, received placebo. In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery and abnormal cases are recorded. In the second and third trimester, women’s serum samples are evaluated for TSH, T4 and T3uptake and newborns’ serum samples are collected for TSH analysis. The intervention groups is compared with control group according to pregnancy outcome including: abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membrane, third trimester hemorrhage and newborns’ thyroid hormone levels at birth.
empty
This study will be conducted in two parts: in the first stage thyroid hormones are tested in 1600 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody are identified. Three times urine during a week are also sampled for iodine measurement. Women with TPOAb negative (more than 50 kIU/l) and TSH between 2.5 and 10 mIU/ liter in the first 20 weeks of pregnancy, will enter into the second phase of the study. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly (based on the odd or even sample code) into two groups. The first group, intervention group, is treated with levothyroxine. The second group, control group, received placebo. In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery and abnormal cases are recorded. In the second and third trimester, women’s serum samples are evaluated for TSH, T4 and T3uptake and newborns’ serum samples are collected for TSH analysis. The intervention groups is compared with control group according to pregnancy outcome including: abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membrane, third trimester hemorrhage and newborns’ thyroid hormone levels at birth.
این مطالعه در دو بخش انجام می شود در مرحله اول با بررسی آزمایشات تیروئیدی 1600 خانم باردار در 20 هفته اول بارداری، افراد مبتلا به هیپوتیروئیدی نهفته با آنتی بادی پراکسیداز تیروئید منفی شناسایی می شوند. برای هر فرد مورد مطالعه سه نمونه ادرار جهت اندازه گیری ید ادرار نیز بررسی می گردند. افراد TPOAb منفی (تیتر پایین تر از 50 کیلو واحد بین المللی در لیتر) با TSH بین 2.5 تا 10 میلی واحد بین المللی در لیتر در 20 هفته اول بارداری به مرحله دوم مطالعه راه می یابند. در مرحله دوم زنان مبتلا به هیپوتیروئیدی نهفته با TPOAb منفی بطور تصادفی ساده (بر اساس زوج یا فرد بودن کد نمونه ها) به دو گروه مداخله و کنترل تقسیم می شوند. گروه اول گروه مداخله می باشند که تحت درمان با لووتیروکسین قرار می گیرند و گروه دوم دارونما دریافت می نمایند. نمونه های سرمی مادر در سه ماهه دوم، سوم تهیه می گردد. هر دو گروه تا زمان زایمان مورد پیگیری قرار می گیرند و موارد غیر طبیعی ثبت می گردند. نمونه های سرمی سه ماهه دوم، و سوم از نظر TSH ، T4 وT3uptake و نمونه سرمی نوزاد از نظر TSH مورد ارزیابی قرار می گیرند. گروه های مداخله و کنترل از نظر پیامدهای حاملگی و زایمان شامل سقط، زایمان زودرس، وزن کم هنگام تولد، محدودیت رشد داخل رحمی، پارگی زودرس کیسه آب، خونریزی سه ماهه سوم و سطح هورمونهای تیروئیدی بدو تولد نوزاد مورد مقایسه قرار می گیرند.
empty
این مطالعه در دو بخش انجام می شود در مرحله اول با بررسی آزمایشات تیروئیدی 1600 خانم باردار در 20 هفته اول بارداری، افراد مبتلا به هیپوتیروئیدی نهفته با آنتی بادی پراکسیداز تیروئید منفی شناسایی می شوند. برای هر فرد مورد مطالعه سه نمونه ادرار جهت اندازه گیری ید ادرار نیز بررسی می گردند. افراد TPOAb منفی (تیتر پایین تر از 50 کیلو واحد بین المللی در لیتر) با TSH بین 2.5 تا 10 میلی واحد بین المللی در لیتر در 20 هفته اول بارداری به مرحله دوم مطالعه راه می یابند. در مرحله دوم زنان مبتلا به هیپوتیروئیدی نهفته با TPOAb منفی بطور تصادفی ساده (بر اساس زوج یا فرد بودن کد نمونه ها) به دو گروه مداخله و کنترل تقسیم می شوند. گروه اول گروه مداخله می باشند که تحت درمان با لووتیروکسین قرار می گیرند و گروه دوم دارونما دریافت می نمایند. نمونه های سرمی مادر در سه ماهه دوم، سوم تهیه می گردد. هر دو گروه تا زمان زایمان مورد پیگیری قرار می گیرند و موارد غیر طبیعی ثبت می گردند. نمونه های سرمی سه ماهه دوم، و سوم از نظر TSH ، T4 وT3uptake و نمونه سرمی نوزاد از نظر TSH مورد ارزیابی قرار می گیرند. گروه های مداخله و کنترل از نظر پیامدهای حاملگی و زایمان شامل سقط، زایمان زودرس، وزن کم هنگام تولد، محدودیت رشد داخل رحمی، پارگی زودرس کیسه آب، خونریزی سه ماهه سوم و سطح هورمونهای تیروئیدی بدو تولد نوزاد مورد مقایسه قرار می گیرند.
empty
Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody.
Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody.
empty
تعیین اثربخشی مداخله با لووتیروکسین بر پیامد بارداری در زنان حامله مبتلا به هیپوتیروئیدی نهفته و آنتی بادی تیروئید پراکسیداز منفی
تعیین اثربخشی مداخله با لووتیروکسین بر پیامد بارداری در زنان حامله مبتلا به هیپوتیروئیدی نهفته و آنتی بادی تیروئید پراکسیداز منفی
empty
]n the first stage thyroid hormones are tested in 160 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and TPOAb negative are identified. The urines of these women are also sampled for iodine measurement. The second stage is a parallel group randomised clinical trial with control group, community based and one blinded study. it is phase two of clinical trials. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly into two groups using permuted block randomization . The first group, intervention group, is treated with levothyroxine. The second group, as control group did not receive intervention.In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery.
]n the first stage thyroid hormones are tested in 160 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and TPOAb negative are identified. The urines of these women are also sampled for iodine measurement. The second stage is a parallel group randomised clinical trial with control group, community based and one blinded study. it is phase two of clinical trials. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly into two groups using permuted block randomization . The first group, intervention group, is treated with levothyroxine. The second group, as control group did not receive intervention.In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery.
empty
در مرحله اول با بررسی آزمایشات تیروئیدی 160 خانم باردار در 20 هفته اول بارداری، افراد مبتلا به هیپوتیروئیدی نهفته با آنتی بادی پراکسیداز تیروئید منفی شناسایی می شوند. برای هر فرد مورد مطالعه سه نمونه ادرار جهت اندازه گیری ید ادرار نیز بررسی می گردند. مرحله دوم، یک مطالعه کارآزمایی بالینی تصادفی دارای گروه کنترل، مبتنی بر جامعه با گروههای موازی یک سو کور می باشد و فاز دو کارآزمایی بالینی است. در این مرحله زنان مبتلا به هیپوتیروئیدی نهفته با TPOAb منفی بطور تصادفی سازی بلوک به دو گروه مداخله و کنترل تقسیم می شوند. گروه اول گروه مداخله می باشند که تحت درمان با لووتیروکسین قرار می گیرند و گروه دوم بعنوان گروه کنترل مداخله ای دریافت نمی کنند. نمونه های سرمی مادر در سه ماهه دوم، سوم تهیه می گردد. هر دو گروه تا زمان زایمان مورد پیگیری قرار می گیرند.
در مرحله اول با بررسی آزمایشات تیروئیدی 160 خانم باردار در 20 هفته اول بارداری، افراد مبتلا به هیپوتیروئیدی نهفته با آنتی بادی پراکسیداز تیروئید منفی شناسایی می شوند. برای هر فرد مورد مطالعه سه نمونه ادرار جهت اندازه گیری ید ادرار نیز بررسی می گردند. مرحله دوم، یک مطالعه کارآزمایی بالینی تصادفی دارای گروه کنترل، مبتنی بر جامعه با گروههای موازی یک سو کور می باشد و فاز دو کارآزمایی بالینی است. در این مرحله زنان مبتلا به هیپوتیروئیدی نهفته با TPOAb منفی بطور تصادفی سازی بلوک به دو گروه مداخله و کنترل تقسیم می شوند. گروه اول گروه مداخله می باشند که تحت درمان با لووتیروکسین قرار می گیرند و گروه دوم بعنوان گروه کنترل مداخله ای دریافت نمی کنند. نمونه های سرمی مادر در سه ماهه دوم، سوم تهیه می گردد. هر دو گروه تا زمان زایمان مورد پیگیری قرار می گیرند.
empty
Data collection from pregnant women is done in prenatal care clinics. A comprehensive questionnaire including demographics, reproductive, medical and prenatal history was completed. Thyroid tests are performed to diagnose pregnant women with subclinical hypothyroidism TPOAb negative.
Data collection from pregnant women is done in prenatal care clinics. A comprehensive questionnaire including demographics, reproductive, medical and prenatal history was completed. Thyroid tests are performed to diagnose pregnant women with subclinical hypothyroidism TPOAb negative.
empty
جمع آوری اطلاعات از خانمهای باردار مورد بررسی در درمانگاههای مراقبتهای دوران بارداری انجام می گردد. یک پرسشنامه جامع شامل اطلاعات دموگرافیک، سابقه مامایی و پزشکی تکمیل می گردد. آزمایشات تیروئیدی برای تشخیص خانمهای باردار مبتلا به هیپوتیروئیدی نهفته TPOAb منفی انجام می شود.
جمع آوری اطلاعات از خانمهای باردار مورد بررسی در درمانگاههای مراقبتهای دوران بارداری انجام می گردد. یک پرسشنامه جامع شامل اطلاعات دموگرافیک، سابقه مامایی و پزشکی تکمیل می گردد. آزمایشات تیروئیدی برای تشخیص خانمهای باردار مبتلا به هیپوتیروئیدی نهفته TPOAb منفی انجام می شود.
empty
pregnant women during the first 20 weeks of pregnancy should not have contraindications for taking levothyroxine contraindication of
pregnant women during the first 20 weeks of pregnancy should not have contraindications for taking levothyroxine contraindication of
empty
خانمهای باردار 20 هفته اول بارداری می باشند که دارای منع مصرفی برای مصرف لووتیروکسین نمی باشند.
خانمهای باردار 20 هفته اول بارداری می باشند که دارای منع مصرفی برای مصرف لووتیروکسین نمی باشند.
empty
The intervention group, is treated with levothyroxine. The control group does not receive intervention.
The intervention group, is treated with levothyroxine. The control group does not receive intervention.
empty
گروه مداخله تحت درمان با لووتیروکسین قرار می گیرند و گروه کنترل مداخله ای دریافت نمی کنند.
گروه مداخله تحت درمان با لووتیروکسین قرار می گیرند و گروه کنترل مداخله ای دریافت نمی کنند.
empty
Abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membranes and third trimester hemorrhage
Abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membranes and third trimester hemorrhage
empty
سقط، زایمان زودرس، وزن کم هنگام تولد، محدودیت رشد داخل رحمی، پارگی زودرس کیسه آب و خونریزی سه ماهه سوم
سقط، زایمان زودرس، وزن کم هنگام تولد، محدودیت رشد داخل رحمی، پارگی زودرس کیسه آب و خونریزی سه ماهه سوم
General information
1
1
1
1
Used
Not used
usednused
160
1600
1601600
Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
Assessment of the effect of Levothyroxine on pregnancy outcome in comparison with placebo in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
تعیین اثربخشی مداخله با لووتیروکسین بر پیامد بارداری در مقایسه با دارونما در زنان حامله مبتلا به هیپوتیروئیدی نهفته و آنتی بادی تیروئید پراکسیداز منفی
تعیین اثربخشی مداخله با لووتیروکسین بر پیامد بارداری در زنان حامله مبتلا به هیپوتیروئیدی نهفته و آنتی بادی تیروئید پراکسیداز منفی
تعیین اثربخشی مداخله با لووتیروکسین بر پیامد بارداری در مقایسه با دارونما در زنان حامله مبتلا به هیپوتیروئیدی نهفته و آنتی بادی تیروئید پراکسیداز منفی
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.
شرایط ورود: خانمهای باردار 20 هفته اول بارداری می باشند که دارای منع مصرفی برای مصرف لووتیروکسین نمی باشند.
شرایط ورود: خانمهای باردار 20 هفته اول بارداری می باشند که دارای منع مصرفی برای مصرف لووتیروکسین نمی باشند.
contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension
contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension
بیماری های وخیم قلبی عروقی همچون نارسایی عروق کرونر،
سابقه سکته قلبی،
فشار خون کنترل نشده
بیماری های وخیم قلبی عروقی همچون نارسایی عروق کرونر، سابقه سکته قلبی، فشار خون کنترل نشده
In this clinical trial no subject knows whether she is receiving particular treatments (levothyroxine) or lack of treatment (placebo), but the administrator does have that information.
In this clinical trial no subject knows whether she is receiving particular treatments (levothyroxine) or lack of treatment (placebo), but the administrator does have that information.
در این کارآزمایی بالینی هیچ یک از نمونه ها نمی دانند که آیا درمان ویژه (لووتیروکسین) را دریافت می دارند یا بدون درمان (دارونما) می باشند ولی فرد اداره کننده از این موضوع مطلع می باشد.
در این کارآزمایی بالینی هیچ یک از نمونه ها نمی دانند که آیا درمان ویژه (لووتیروکسین) را دریافت می دارند یا بدون درمان (دارونما) می باشند ولی فرد اداره کننده از این موضوع مطلع می باشد.
empty
Study subjects are randomly divided into two groups using permuted block randomization to achieve balance across treatment groups. The number of subjects per block will be four.
Study subjects are randomly divided into two groups using permuted block randomization to achieve balance across treatment groups. The number of subjects per block will be four.
empty
افراد مورد مطالعه با استفاده از روش تصادفی سازی بلوک به دو گروه برای به دست آوردن تعادل در میان گروه های درمان تقسیم می شوند. تعداد افراد در هر بلوک چهار نفر خواهد بود.
افراد مورد مطالعه با استفاده از روش تصادفی سازی بلوک به دو گروه برای به دست آوردن تعادل در میان گروه های درمان تقسیم می شوند. تعداد افراد در هر بلوک چهار نفر خواهد بود.
empty
A sealed opaque envelope will be assigned to each subject, only the midwife treating the women, who will not participate in any subsequent phase of the study, knows in which group each patient is.
A sealed opaque envelope will be assigned to each subject, only the midwife treating the women, who will not participate in any subsequent phase of the study, knows in which group each patient is.
empty
یک پاکت غیرشفاف مهر و موم شده به هر شرکت کننده اختصاص داده می شود، تنها ماما مرتبط با درمان زنان، که در هیچ مرحله بعدی مطالعه شرکت نمی کنند، می داند که هر بیمار در کدام گروه است.
یک پاکت غیرشفاف مهر و موم شده به هر شرکت کننده اختصاص داده می شود، تنها ماما مرتبط با درمان زنان، که در هیچ مرحله بعدی مطالعه شرکت نمی کنند، می داند که هر بیمار در کدام گروه است.
Intervention groups
#1
Placebo
N/A
placebona
Will take placebo.
The control group does not receive intervention.
Will take placeboThe control group does not receive intervention.
گروه دوم پلاسبو دریافت می نمایند.
گروه کنترل مداخله ای دریافت نمی دارند.
گروه دوم پلاسبوکنترل مداخله ای دریافت می نمایندنمی دارند.
Recruitment centers
#1
Name of recruitment center - English: Health centers of Varamin, Pishva and Qarchak
Name of recruitment center - Persian: مراکز بهداشتی درمانی ورامین، پیشوا و قرچک
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Street address - English: Varamin, Pishva , Qarchak
Street address - Persian: ورامین، پیشوا، قرچک
City - English: Varamin
City - Persian: ورامین
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Health centers of Varamin, Pishva and Qarchak
Name of recruitment center - Persian: مراکز بهداشتی درمانی ورامین، پیشوا و قرچک
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Street address - English: Varamin, Pishva , Qarchak
Street address - Persian: ورامین، پیشوا، قرچک
City - English: Varamin
City - Persian: ورامین
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2243 2500
Fax:
Email: snazarpour@gmail.com
Web page address:
Name of recruitment center - English: Health centers of Varamin, Pishva and Qarchak Name of recruitment center - Persian: مراکز بهداشتی درمانی ورامین، پیشوا و قرچک Full name of responsible person - English: Sima Nazarpour Full name of responsible person - Persian: سیما نظرپور Street address - English: Varamin, Pishva , Qarchak Street address - Persian: ورامین، پیشوا، قرچک City - English: Varamin City - Persian: ورامین Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2243 2500 Fax: Email: snazarpour@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Afshin Zarghi (Vice chancellor for research, Shahid Beheshti University of Medical Sciences)
Full name of responsible person - Persian: افشین زرقی (معاون پژوهشی دانشگاه علوم پزشکی شهید بهشتی)
Street address - English: Velenjak Street , Shahid Chamran Highway, Tehran.
Street address - Persian: تهران، بزرگراه شهید چمران، خیابان ولنجک
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Afshin Zarghi (Vice chancellor for research, Shahid Beheshti University of Medical Sciences)
Full name of responsible person - Persian: افشین زرقی (معاون پژوهشی دانشگاه علوم پزشکی شهید بهشتی)
Street address - English: Velenjak Street , Shahid Chamran Highway, Tehran.
Street address - Persian: تهران، بزرگراه شهید چمران، خیابان ولنجک
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2243 2500
Fax:
Email: fah.tehrani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Afshin Zarghi (Vice chancellor for research, Shahid Beheshti University of Medical Sciences) Full name of responsible person - Persian: افشین زرقی (معاون پژوهشی دانشگاه علوم پزشکی شهید بهشتی) Street address - English: Velenjak Street , Shahid Chamran Highway, Tehran. Street address - Persian: تهران، بزرگراه شهید چمران، خیابان ولنجک City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2243 2500 Fax: Email: fah.tehrani@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences, Midwifery and Nursing department
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی، دانشکده پرستاری و مامایی
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Position - English: PhD student in the field of Reproductive Health
Position - Persian: دانشجوی دکترای بهداشت باروری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8865 5366
Mobile: +98 912 389 5124
Fax:
Email: simanazarpour@sbmu.ac.ir; nazarpoursima@yahoo
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Position - English: Assistant Professor, PhD of Reproductive Health
Position - Persian: استادیار، دکترای بهداشت باروری
Latest degree: phd
Area of specialty/work: 1
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 8865 5366
Mobile: +98 912 389 5124
Fax:
Email: simanazarpour@sbmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University of Medical Sciences, Midwifery and Nursing department Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی، دانشکده پرستاری و مامایی Full name of responsible person - English: Sima Nazarpour Full name of responsible person - Persian: سیما نظرپور Position - English: Assistant Professor, PhD student in the field of Reproductive Health Position - Persian: دانشجویاستادیار، دکترای بهداشت باروری Latest degree: phd Area of specialty/work: 01 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 8865 5366 Mobile: +98 912 389 5124 Fax: Email: simanazarpour@sbmu.ac.ir; nazarpoursima@yahoo Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشکده علوم غدد درون ریز و متابولیسم دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Fahimeh Ramezani Tehrani
Full name of responsible person - Persian: فهیمه رمضانی تهرانی
Position - English: Gynecologist
Position - Persian: متخصص زنان و زایمان
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Street address - Persian: ایران، تهران، بزرگراه شهید چمران، خیابان ولنجک
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 2243 2500
Mobile: +98 912 601 8211
Fax:
Email: fah.tehrani@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Name of organization / entity - Persian: پژوهشکده علوم غدد درون ریز و متابولیسم دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Fahimeh Ramezani Tehrani
Full name of responsible person - Persian: فهیمه رمضانی تهرانی
Position - English: Gynecologist
Position - Persian: متخصص زنان و زایمان
Latest degree: specialist
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Velenjak St. , Shahid Chamran Highway, Tehran, Iran
Street address - Persian: ایران، تهران، بزرگراه شهید چمران، خیابان ولنجک
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2243 2500
Mobile: +98 912 601 8211
Fax:
Email: fah.tehrani@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Name of organization / entity - Persian: پژوهشکده علوم غدد درون ریز و متابولیسم دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Fahimeh Ramezani Tehrani Full name of responsible person - Persian: فهیمه رمضانی تهرانی Position - English: Gynecologist Position - Persian: متخصص زنان و زایمان Latest degree: specialist Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Velenjak St. , Shahid Chamran Highway, Tehran, Iran Street address - Persian: ایران، تهران، بزرگراه شهید چمران، خیابان ولنجک City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2243 2500 Mobile: +98 912 601 8211 Fax: Email: fah.tehrani@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences, Nursing and Midwifery department
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی، دانشکده پرستاری و مامایی
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Position - English: PhD student in the field of Reproductive Health
Position - Persian: دانشجوی دکترای بهداشت باروری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: +98 912 389 5124
Fax:
Email: nazarpoursima@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University of Medical Sciences, Nursing and Midwifery department
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی، دانشکده پرستاری و مامایی
Full name of responsible person - English: Sima Nazarpour
Full name of responsible person - Persian: سیما نظرپور
Position - English: Assistant Professor,PhD of Reproductive Health
Position - Persian: استادیار، دکترای بهداشت باروری
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: 00
Mobile: +98 912 389 5124
Fax:
Email: nazarpoursima@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University of Medical Sciences, Nursing and Midwifery department Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی، دانشکده پرستاری و مامایی Full name of responsible person - English: Sima Nazarpour Full name of responsible person - Persian: سیما نظرپور Position - English: PhD student in the fieldAssistant Professor,PhD of Reproductive Health Position - Persian: دانشجویاستادیار، دکترای بهداشت باروری Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran Street address - Persian: تهران، خیابان ولی عصر، تقاطع نیایش، دانشکده پرستاری و مامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: 00 Mobile: +98 912 389 5124 Fax: Email: nazarpoursima@yahoo.com Web page address:
Context
Currently, there is no consensus on universal thyroid screening and levothyroxine (LT4) treatment of pregnant women with subclinical hypothyroidism (SCH) who are negative for thyroid peroxidase antibody (TPOAb−).
Objective
We aimed to evaluate the benefits of LT4 treatment on pregnancy outcomes in SCH-TPOAb− women.
Design
This study was conducted within the framework of the Tehran Thyroid and Pregnancy Study. A single-blind randomized clinical trial was undertaken in pregnant women who were SCH-TPOAb−.
Setting
Prenatal care centers of the Shahid Beheshti University of Medical Sciences.
Patients
Using the thyrotropin (TSH) cut point of 2.5 mIU/L, 366 SCH-TPOAb− and 1092 euthyroid TPOAb− women were recruited.
Intervention
SCH-TPOAb− women were randomly assigned to two groups: group A (n = 183) who were treated with LT4 and group B (n = 183) who received no treatment. A total of 1,028 euthyroid TPOAb− women served as the control group (group C).
Main Outcome Measure
The primary outcome was the rate of preterm delivery.
Results
Using the TSH cutoff of 2.5 mIU/L, no significant difference in preterm delivery was observed between groups A and B [relative risk (RR): 0.86; 95% confidence interval (CI): 0.47 to 1.55; P = 0.61]. However, log-binomial model analysis based on a cut point of 4.0 mIU/L demonstrated a significantly lower rate of preterm delivery in LT4-treated women compared with those who received no treatment (RR: 0.38; 95% CI: 0.15 to 0.98; P = 0.04).
Conclusions
Despite no beneficial effect of LT4 therapy in reducing preterm delivery in SCH-TPOAb− women with a TSH cut point of 2.5 to 4 mIU/L, LT4 could precisely decrease this complication using the newly recommended cutoff ≥4.0 mIU/L.
Context Currently, there is no consensus on universal thyroid screening and levothyroxine (LT4) treatment of pregnant women with subclinical hypothyroidism (SCH) who are negative for thyroid peroxidase antibody (TPOAb−). Objective We aimed to evaluate the benefits of LT4 treatment on pregnancy outcomes in SCH-TPOAb− women. Design This study was conducted within the framework of the Tehran Thyroid and Pregnancy Study. A single-blind randomized clinical trial was undertaken in pregnant women who were SCH-TPOAb−. Setting Prenatal care centers of the Shahid Beheshti University of Medical Sciences. Patients Using the thyrotropin (TSH) cut point of 2.5 mIU/L, 366 SCH-TPOAb− and 1092 euthyroid TPOAb− women were recruited. Intervention SCH-TPOAb− women were randomly assigned to two groups: group A (n = 183) who were treated with LT4 and group B (n = 183) who received no treatment. A total of 1,028 euthyroid TPOAb− women served as the control group (group C). Main Outcome Measure The primary outcome was the rate of preterm delivery. Results Using the TSH cutoff of 2.5 mIU/L, no significant difference in preterm delivery was observed between groups A and B [relative risk (RR): 0.86; 95% confidence interval (CI): 0.47 to 1.55; P = 0.61]. However, log-binomial model analysis based on a cut point of 4.0 mIU/L demonstrated a significantly lower rate of preterm delivery in LT4-treated women compared with those who received no treatment (RR: 0.38; 95% CI: 0.15 to 0.98; P = 0.04). Conclusions Despite no beneficial effect of LT4 therapy in reducing preterm delivery in SCH-TPOAb− women with a TSH cut point of 2.5 to 4 mIU/L, LT4 could precisely decrease this complication using the newly recommended cutoff ≥4.0 mIU/L.
Protocol summary
Study aim
Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody.
Design
]n the first stage thyroid hormones are tested in 160 pregnant women in the first 20 weeks of pregnancy and pregnant women with subclinical hypothyroidism and TPOAb negative are identified. The urines of these women are also sampled for iodine measurement. The second stage is a parallel group randomised clinical trial with control group, community based and one blinded study. it is phase two of clinical trials. In the second stage of study, pregnant women with subclinical hypothyroidism and negative TPOAb are divided simple randomly into two groups using permuted block randomization . The first group, intervention group, is treated with levothyroxine. The second group, as control group did not receive intervention.In the second and third trimester, maternal serum samples are taken. Both groups are followed up until delivery.
Settings and conduct
Data collection from pregnant women is done in prenatal care clinics. A comprehensive questionnaire including demographics, reproductive, medical and prenatal history was completed. Thyroid tests are performed to diagnose pregnant women with subclinical hypothyroidism TPOAb negative.
Participants/Inclusion and exclusion criteria
pregnant women during the first 20 weeks of pregnancy should not have contraindications for taking levothyroxine contraindication of
Intervention groups
The intervention group, is treated with levothyroxine. The control group does not receive intervention.
Main outcome variables
Abortion, preterm labor, low birth weight, intrauterine growth restriction, premature rupture of membranes and third trimester hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2013121214849N3
Registration date:2014-01-06, 1392/10/16
Registration timing:registered_while_recruiting
Last update:2018-07-17, 1397/04/26
Update count:1
Registration date
2014-01-06, 1392/10/16
Registrant information
Name
Sima Nazarpour
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 0340
Email address
simanazarpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of Levothyroxine on pregnancy outcome in pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
Public title
The effect of Levothyroxine on pregnancy outcome of pregnant women with subclinical hypothyroidism and negative thyroid peroxidase antibody
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: pregnant women during the first 20 weeks of pregnancy.
Exclusion criteria:
contraindication of Levothyroxine use include: patients with severe cardiovascular diseases such as coronary heart failure, history of myocardial infarction, uncontrolled hypertension
Age
From 15 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
1600
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects are randomly divided into two groups using permuted block randomization to achieve balance across treatment groups. The number of subjects per block will be four.
Blinding (investigator's opinion)
Single blinded
Blinding description
A sealed opaque envelope will be assigned to each subject, only the midwife treating the women, who will not participate in any subsequent phase of the study, knows in which group each patient is.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Blood pressure measuring devices
3
Description
Edema
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist
4
Description
Fetal heart rate (FHR)
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Pinard Stethoscope
5
Description
Headache
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist
6
Description
Vaginal bleeding
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation) and during labor
Method of measurement
Checklist
7
Description
Uterine contractions
Timepoint
After the intervention, during routine care in pregnancy (16 to 20 weeks, 26 to 30 weeks, 31 to 34 weeks, 35 to 37 weeks, 38 weeks, 39 weeks, 40 or 41 weeks of gestation)
Method of measurement
Checklist
8
Description
Type of delivery
Timepoint
Delivery (5 to 7 months after intervention)
Method of measurement
Checklist
9
Description
Postpartum atonia
Timepoint
Postpartum (5 to 7 months after intervention)
Method of measurement
Checklist
10
Description
Postpartum hemorrhage
Timepoint
Postpartum (5 to 7 months after intervention)
Method of measurement
Checklist
11
Description
Newborn Apgar
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Apgar Apgar scoring
12
Description
Hospitalization in neonatal intensive care unit (NICU)
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist
13
Description
Newborn convulsion
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist
14
Description
Newborn icterus
Timepoint
After birth (5 to 7 months after intervention)
Method of measurement
Checklist
Intervention groups
1
Description
Intervention group will treat with Levoxine (Levothyroxine sodium). These patients will receive 1 mg per kg of body weight daily levothyroxine. Dosages will maintain throughout pregnancy until delivery. In this study are used from Levothyroxine sodium 0.1 mg manufactured by Iran Hormone.
Category
Treatment - Drugs
2
Description
The control group does not receive intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Varamin, Pishva and Qarchak
Full name of responsible person
Sima Nazarpour
Street address
Varamin, Pishva , Qarchak
City
Varamin
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
snazarpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi (Vice chancellor for research, Shahid Beheshti University of Medical Sciences)
Street address
Velenjak Street , Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
fah.tehrani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sima Nazarpour
Position
Assistant Professor, PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 8865 5366
Fax
Email
simanazarpour@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Ramezani Tehrani
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Street address
Velenjak St. , Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Fax
Email
fah.tehrani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Nursing and Midwifery department
Full name of responsible person
Sima Nazarpour
Position
Assistant Professor,PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Niayesh st., Vali Asr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
00
Fax
Email
nazarpoursima@yahoo.com
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
-
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document