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
Comparison of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimester in high-risk pregnant mothers for preeclampsia
prevention of occurrence of early and late preeclampsia
Comparisonprevention of the effectoccurrence of the early start of aspirin in the early first trimester to pregnant women's compared to theand late first trimester in high-risk pregnant mothers for preeclampsia
مقایسه ی میزان تاثیر شروع زودرس آسپرین در اوایل تریمستر اول جهت پیشگیری از پره اکلامپسی نسبت به اواخر تریمستر اول در مادران باردار پرخطر
پیشگیری از بروز پره اکلامپسی زودرس و دیررس
مقایسه ی میزان تاثیر شروع زودرس آسپرین در اوایل تریمستر اول جهت پیشگیری از بروز پره اکلامپسی نسبت به اواخر تریمستر اول در مادران باردار پرخطرزودرس و دیررس
Randomized clinical trial. Phase 3. Double-blind. Two intervention groups and control group with randomization of two-allele random blocks of size 6 with ratio of intervention to control: one to one on 100 samples in each group
Randomized clinical trial.Assessor-blinded. Two intervention groups and control group.
Randomized clinical trial. Phase 3. Doubletrial.Assessor-blindblinded. Two intervention groups and control group with randomization of two-allele random blocks of size 6 with ratio of intervention to control: one to one on 100 samples in each group.
کارآزمایی بالینی تصادفی.فاز3.دوسوکور.دو گروه مداخله و کنترل. تصادفی سازی بلوکهای تصادفی دو آللی سایز 6 با نسبت مداخله به کنترل: یک به یک بر روی 100 نمونه در هر گروه
کارآزمایی بالینی تصادفی.یک سوکور.دو گروه مداخله و کنترل.
کارآزمایی بالینی تصادفی.فاز3.دوسوکور.دوتصادفی.یک سوکور.دو گروه مداخله و کنترل. تصادفی سازی بلوکهای تصادفی دو آللی سایز 6 با نسبت مداخله به کنترل: یک به یک بر روی 100 نمونه در هر گروه
In a study designed based on the demographic characteristics and maternal medical and obstetric history of high-risk women (including a history of pre-eclampsia in the patient or in the mother and sister-kidney diseases or overt diabetes or autoimmune diseases or obstetric complications such as eclampsia or chronic high blood pressure -Pregnancy-distance between pregnancies and other cases) are identified and the above women are randomly divided into two equal groups. In the first group, low-dose aspirin with a daily dose of 80 mg started at the beginning of the first trimester with the formation of the fetal heart rate and continued until the end of the 36th week of pregnancy or until delivery if it occurs before this time.
In the second group, aspirin with a dose of 80 mg started from 11-13 weeks and 6 days and until the end of 36 week or until delivery
At each visit, the presence of edema or preeclampsia symptoms are noted and recorded. In addition, participants are assessed for possible aspirin side effects.
Participants are randomly selected to receive low-dose aspirin, either before 11 weeks’ gestation (optimally from the detection of the fetal heart beat) in the intervention group or after 11 weeks in the control group. The cut-off gestational age to receive aspirin is 16 weeks in the control group. In both groups, the initial dose of aspirin is 80 mg per day. In both groups, aspirin will be continued until 36 weeks or in the case of premature delivery.
At 11_13 weeks and 6 days, when the gestational age is confirmed by an ultrasound study of the CRL measurement through the fetal NT measurement, the UTA-PI of uterine arteries is assessed transabdominally. In addition, a combined test for aneuploidy screening is requested through measuring the maternal serum free β-hcG and PAPP-A.
If there are criteria in both groups including:
PAPP-A < 0.4 in the first trimester or
preeclampsia risk more than or equal1 ̸ 100 to in aneuploidy screening test or
in color doppler ultrasound (the mean UTA-PI>95th percentile or bilateral notching), the initial dose of aspirin, which is 80 mg, is changed to 150 mg per day.
In a study designed based onAt each visit, the demographic characteristicspresence of edema or preeclampsia symptoms are noted and maternal medical and obstetric history of high-risk women (including a history of pre-eclampsia in the patient or in the mother and sister-kidney diseases or overt diabetes or autoimmune diseases or obstetric complications such as eclampsia or chronic high blood pressure -Pregnancy-distance between pregnancies and other cases)recorded. In addition, participants are identified and the above womenassessed for possible aspirin side effects. Participants are randomly divided into two equal groups. In the first group,selected to receive low-dose aspirin with a daily dose of 80 mg started at, either before 11 weeks’ gestation (optimally from the beginning of the first trimester with the formationdetection of the fetal heart rate andbeat) in the intervention group or after 11 weeks in the control group. The cut-off gestational age to receive aspirin is 16 weeks in the control group. In both groups, the initial dose of aspirin is 80 mg per day. In both groups, aspirin will be continued until 36 weeks or in the endcase of the 36th week of pregnancy or untilpremature delivery if it occurs before this time. In the second group, aspirin with a dose of 80 mg started fromAt 11-_13 weeks and 6 days, when the gestational age is confirmed by an ultrasound study of the CRL measurement through the fetal NT measurement, the UTA-PI of uterine arteries is assessed transabdominally. In addition, a combined test for aneuploidy screening is requested through measuring the maternal serum free β-hcG and untilPAPP-A. If there are criteria in both groups including: PAPP-A < 0.4 in the endfirst trimester or preeclampsia risk more than or equal1 ̸ 100 to in aneuploidy screening test or in color doppler ultrasound (the mean UTA-PI>95th percentile or bilateral notching), the initial dose of 36 week or until deliveryaspirin, which is 80 mg, is changed to 150 mg per day.
در مطالعه طراحی شده بر اساس ویژگی های دموگرافیک و شرح حال طبی و مامایی مادری زنان پرخطر(شامل سابقه پره اکلامپسی در بیمار یا در مادر و خواهر-بیماریهای کلیوی یا دیابت اشکار یا بیماریهای اتوایمیون یا عوارض مامایی مثل دکولمان جغت یا فشار خون مزمن بالا-گراویدیتی-فاصله بین حاملگیها و سایر موارد) شناسایی شده و زنان فوق به صورت رندوم به دو گروه مساوی تقسیم می شوند. در گروه اول دوز پایین آسپرین با دوز ۸۰ میلی گرم روزانه؛همزمان با تشکیل ضربان قلب جنین ازاوایل تریمستر اول شروع شده وتا انتهای ۳۶ هفته کامل حاملگی یا تا زمان زایمان د رصورت رخ دادن قبل این زمان ادامه می یابد.
در گروه دوم بر اساس غربالگری ترکیبی شامل تغییرات دموگرافیک-داپلر شریان رحمی-سطح سرمیPAPP-A (طبق گایدلاین های حال حاضر) آسپرین با دوز ۸۰ میلی گرم از ۱۱-۱۳هفته و ۶ روز شروع شده(طبق الگوریتمهای فعلی) و تا پایان ۳۶ هفته یا تا زمان زایمان در صورت رخ دادن قبل از این زمان ادامه می یابد.
پس از گرفتن رضایت نامه کتبی آگاهانه که به تایید کمیته اخلاق رسیده است آسپرین در گروه مداخله از زمان تشکیل ضربان قلب جنین با سونو با دوز 80 میلی و در گروه کنترل از بعد از 11 هفته در گروه کنترل با همان دوز شروع میشود و در 11-13هفته و 6 روز سونوگرافی NT و آزمایش سرم برای غربالگری آناپلوییدی بر اساس اندازه گیری سطح سرمی B-hcG و PAPP-A دخواست میشود که در صورت وجود /ریسک پره اکلامپسی >= 1/100 یا میزان PAPP-A<0.4 یا در داپلر شریانهای رحمی وجود Mean PI>=95% یا notching(دندانه دار شدن موج داپلر) / دوز آسپرین در هر دو گوه به 150 میلی افزایش می یابد.30 روز بعد از شروع آسپرین یک مصاحبه تلفنی در مورد عواض احتمالی دارو انجام میشود . در هر ویزیت علاوه بر چک علایم حیاتی و BMI شرکت کننده وجود احتمالی علایم پره اکلامپسی مثل ادم- تاری دید- درد ناحیه فوقانی چپ شکم یا قفسه سینه وسردرد و سرگیجه و همچنین عوارض جانبی دارو بررسی میشوند.در هر دو گروه تا 36 هفته دارو ادامه می یابد.
در مطالعه طراحی شده بر اساس ویژگی های دموگرافیک و شرح حال طبی و مامایی مادری زنان پرخطر(شامل سابقه پره اکلامپسی در بیمار یا در مادر و خواهر-بیماریهای کلیوی یا دیابت اشکار یا بیماریهای اتوایمیون یا عوارض مامایی مثل دکولمان جغت یا فشار خون مزمن بالا-گراویدیتی-فاصله بین حاملگیها و سایر موارد) شناسایی شده و زنان فوقپس از گرفتن رضایت نامه کتبی آگاهانه که به صورت رندوم به دو گروه مساوی تقسیم می شوند.تایید کمیته اخلاق رسیده است آسپرین در گروه اول دوز پایین آسپرین با دوز ۸۰ میلی گرم روزانه؛همزمان بامداخله از زمان تشکیل ضربان قلب جنین ازاوایل تریمستر اولبا سونو با دوز 80 میلی و در گروه کنترل از بعد از 11 هفته در گروه کنترل با همان دوز شروع شده وتا انتهای ۳۶میشود و در 11-13هفته و 6 روز سونوگرافی NT و آزمایش سرم برای غربالگری آناپلوییدی بر اساس اندازه گیری سطح سرمی B-hcG و PAPP-A دخواست میشود که در صورت وجود /ریسک پره اکلامپسی >= 1/100 یا میزان PAPP-A<0.4 یا در داپلر شریانهای رحمی وجود Mean PI>=95% یا notching(دندانه دار شدن موج داپلر) / دوز آسپرین در هر دو گوه به 150 میلی افزایش می یابد.30 روز بعد از شروع آسپرین یک مصاحبه تلفنی در مورد عواض احتمالی دارو انجام میشود . در هر ویزیت علاوه بر چک علایم حیاتی و BMI شرکت کننده وجود احتمالی علایم پره اکلامپسی مثل ادم- تاری دید- درد ناحیه فوقانی چپ شکم یا قفسه سینه وسردرد و سرگیجه و همچنین عوارض جانبی دارو بررسی میشوند.در هر دو گروه تا 36 هفته کامل حاملگی یا تا زمان زایمان د رصورت رخ دادن قبل این زماندارو ادامه می یابد. در گروه دوم بر اساس غربالگری ترکیبی شامل تغییرات دموگرافیک-داپلر شریان رحمی-سطح سرمیPAPP-A (طبق گایدلاین های حال حاضر) آسپرین با دوز ۸۰ میلی گرم از ۱۱-۱۳هفته و ۶ روز شروع شده(طبق الگوریتمهای فعلی) و تا پایان ۳۶ هفته یا تا زمان زایمان در صورت رخ دادن قبل از این زمان ادامه می یابد.
All high-risk pregnant women for preeclampsia
Without any drug sensitivity to aspirin
History of abortion less than 2 times
No medical contraindications for taking aspirin
The participants are pregnant women at high-risk for preeclampsia according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria:
mentioned on he previous page.
AllThe participants are pregnant women at high-risk pregnant women for preeclampsia Without any drug sensitivityaccording to aspirin History of abortion less than 2 times No medical contraindications for taking aspirinthe ACOG and USPSTF and SMFM guidelines. Exclusion criteria: mentioned on he previous page.
تمام زنان باردار پرخطر جهت پره اکلامپسی
بدون هر گونه حساست دارویی به آسپرین
سابقه سقطکمتر از 2 بار
بدون کنترااندیکاسیون طبی دریافت آسپرین
تمام زنان باردار پرخطر جهت پره اکلامپسی بر اساس گایدلاینهای ACOG-USPSTF-SMFM که فاقد نواقص یادگیری و منتال شدید باشند
کرایتریهای خروج: حساسیت شدید دارویی/ آسم-رینیت -پولیپ بینی/ اختلالات شدید کلیوی و کبدی/ شرح حال خونریزی گواشی یا زخم پپتیک/ خونریزی واژینال یا هماتوم وسیع در سونو.
تمام زنان باردار پرخطر جهت پره اکلامپسی بدون هر گونه حساستبر اساس گایدلاینهای ACOG-USPSTF-SMFM که فاقد نواقص یادگیری و منتال شدید باشند کرایتریهای خروج: حساسیت شدید دارویی به آسپرین سابقه سقطکمتر از 2 بار بدون کنترااندیکاسیون طبی دریافت آسپرین/ آسم-رینیت -پولیپ بینی/ اختلالات شدید کلیوی و کبدی/ شرح حال خونریزی گواشی یا زخم پپتیک/ خونریزی واژینال یا هماتوم وسیع در سونو.
Preeclampsia
Early and late preeclampsia
PreeclampsiaEarly and late preeclampsia
پره اکلامپسی
پره اکلامپسی زودرس و دیررس
پره اکلامپسی زودرس و دیررس
General information
Double blinded
Single blinded
doublsingl
1
1
1
1
1
1
2022-12-22, 1401/10/01
2023-01-08, 1401/10/18
20222023-1201-2208 00:00:00
2023-06-22, 1402/04/01
2023-12-08, 1402/09/17
2023-0612-2208 00:00:00
empty
Hello, No major change have been made in the process and metodology of the trial,except for subtleties that help the audience to better and secondly,our tudy include two main parts. The first part, which has been approed in this center,is being done and the results will be announced later. And in the from of a pilo study, as well as the feaibility of conducting the main study and solving possible problems and defects on it way, it has started with 200 participants from January 2023. The second part includes the main RCT with the same metodology. For this eason, this request was made to provide a possibility to accelerate the start of the main trial, considering the success of the pilot tudy process for feasibility in he last 6 months. Thank you very much.
Hello, No major change have been made in the process and metodology of the trial,except for subtleties that help the audience to better and secondly,our tudy include two main parts. The first part, which has been approed in this center,is being done and the results will be announced later. And in the from of a pilo study, as well as the feaibility of conducting the main study and solving possible problems and defects on it way, it has started with 200 participants from January 2023. The second part includes the main RCT with the same metodology. For this eason, this request was made to provide a possibility to accelerate the start of the main trial, considering the success of the pilot tudy process for feasibility in he last 6 months. Thank you very much.
empty
با سلام. تغییرات عمده ای در روند و متدولوژی مطالعه انجام نشده است بجز ظرایفی که به فهم بهتر و واضح تر مخاطبان د روش کار کمک میکند و دوم اینکه مطالعه ما شامل دو بخش اصلی است. بخش اول که در این مرکز کد تایید گرفته است در حال انجام است و نتایج متعاقبا اعلام خواهد شد. و بصورت مطالعه پایلوت و همینطور امکان سنجی انجام مطالعه اصلی و رفع مشکلات و ایرادات احتمالی در مسیر آن با 200 شرکت کننده از ژانویه 2023 شروع شده است.بخش دوم شامل RCT اصلی است با همان متدولوژی. به همین دلیل این درخواست داده شد تا امکانی جهت تسریع در شروع کارازمایی اصلی با توجه به موفقیت امیز بودن بررسی روند مطالعه پایلوت جهت امکان سنجی طی تقریبا 6 ماه گذشته بدست آمد فراهم کند.سپاس فراوان
با سلام. تغییرات عمده ای در روند و متدولوژی مطالعه انجام نشده است بجز ظرایفی که به فهم بهتر و واضح تر مخاطبان د روش کار کمک میکند و دوم اینکه مطالعه ما شامل دو بخش اصلی است. بخش اول که در این مرکز کد تایید گرفته است در حال انجام است و نتایج متعاقبا اعلام خواهد شد. و بصورت مطالعه پایلوت و همینطور امکان سنجی انجام مطالعه اصلی و رفع مشکلات و ایرادات احتمالی در مسیر آن با 200 شرکت کننده از ژانویه 2023 شروع شده است.بخش دوم شامل RCT اصلی است با همان متدولوژی. به همین دلیل این درخواست داده شد تا امکانی جهت تسریع در شروع کارازمایی اصلی با توجه به موفقیت امیز بودن بررسی روند مطالعه پایلوت جهت امکان سنجی طی تقریبا 6 ماه گذشته بدست آمد فراهم کند.سپاس فراوان
Investigation the effect of early initiation of Aspirin in the prevention of preeclampsia in high_ risk mothers.
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
Investigation the effect ofAspirin administration from early pregnancy versus initiation of Aspirin in theafter 11 week’s gestations, for prevention of preeclampsiapre-eclampsia in high_ -risk motherspregnant women.
Comparison of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimester in high-risk pregnant mothers for preeclampsia .
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
ComparisonAspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of the effect of the early start of aspirin in the early first trimester to pregnant women's compared to the late first trimesterpre-eclampsia in high-risk pregnant mothers for preeclampsia women.
All high_ risk pregnant mothers for preeclampsia
The participants are pregnant women at high-risk for preeclampsia based on demographic characteristics and personal and obstetrics history, according to the ACOG and USPSTF and SMFM guidelines.
All high_ riskThe participants are pregnant motherswomen at high-risk for preeclampsia based on demographic characteristics and personal and obstetrics history, according to the ACOG and USPSTF and SMFM guidelines.
تمامی مادران باردار پرخطر از نظر مسمومیت حاملگی(پره اکلامپسی)
تمامی مادران باردار پرخطر از نظر مسمومیت حاملگی(پره اکلامپسی) مطابق با کرایتریهای گایدلاینهای SPSTFACOG-SFMF-U
تمامی مادران باردار پرخطر از نظر مسمومیت حاملگی(پره اکلامپسی) مطابق با کرایتریهای گایدلاینهای SPSTFACOG-SFMF-U
Drug sensitivity to Aspirin
history of more than twice abortion
Any Asprin contraindication
1) Hypersensitivity to nonsteroidal anti-inflammatory drug products
2) Asthma-rhinitis and nasal polyps
3) Sever renal or sever hepatic impairment.
4) History of gastrointestinal bleeding or active peptic ulcer disease
5) vaginal bleeding or significant hematoma on ultrasound.
Drug sensitivity1) Hypersensitivity to Aspirin historynonsteroidal anti-inflammatory drug products 2) Asthma-rhinitis and nasal polyps 3) Sever renal or sever hepatic impairment. 4) History of more than twice abortion Any Asprin contraindicationgastrointestinal bleeding or active peptic ulcer disease 5) vaginal bleeding or significant hematoma on ultrasound.
حساسیت دارویی به آسپرین
یش از دو بار سابقه سقط
کنترااندیکاسیون طبی مصرف آسپرین
حساسیت دارویی به آسپرین
آسم -رینیت -پولیپ نازال
اختلالات شدید کلیوی یا کبدی
هیستوری خونریزی گوارشی یا بیماری اولسر پپتیک
خونریزی واژینال یا هماتوم قابل توجه در سونو
حساسیت دارویی به آسپرین یش از دو بار سابقه سقط کنترااندیکاسیون طبی مصرف آسپرینآسم -رینیت -پولیپ نازال اختلالات شدید کلیوی یا کبدی هیستوری خونریزی گوارشی یا بیماری اولسر پپتیک خونریزی واژینال یا هماتوم قابل توجه در سونو
empty
We calculated that the enrollment of 1792 patients in a 1:1 ratio of distribution (896 patients in each group) would provide the trial with a power of 90% (alpha level of 5%). If we allow for a 10% loss to follow-up, the sample size will reach 986 participants in each group. A total of 1972 eligible participants will be randomly entered into the trial arms. We proposed the sample size of 200 high-risk pregnancies for the pilot study and quality control of the center to perform the main RCT. We reached this sample size by screening 1686 pregnant women who referred to Maternal- Fetal Hospital Clinic. After taking written conscious consent, from January 2023, the trial with 100 participants in each group started with a ratio of 1:1, randomly.
We calculated that the enrollment of 1792 patients in a 1:1 ratio of distribution (896 patients in each group) would provide the trial with a power of 90% (alpha level of 5%). If we allow for a 10% loss to follow-up, the sample size will reach 986 participants in each group. A total of 1972 eligible participants will be randomly entered into the trial arms. We proposed the sample size of 200 high-risk pregnancies for the pilot study and quality control of the center to perform the main RCT. We reached this sample size by screening 1686 pregnant women who referred to Maternal- Fetal Hospital Clinic. After taking written conscious consent, from January 2023, the trial with 100 participants in each group started with a ratio of 1:1, randomly.
empty
برای مطالعه RCT اصلی ما 1792 بیمار با نسبت توزیع 1:1(896 نفر در هر گروه) و محاسبه کردیم.که با محاسبه 10% ریزش در فالوآپ شرکت کنندگان در مجموع به 1972 نفر واجد شرایط( زن باردار پرخطر) یعنی 986 شرکت کننده در هر گروه نیاز داریم. برای مطالعه پایلوت به 200 بیمار نیاز بود که بعد از غربالگری 1686 زن باردار به این حجم رسیدیم. و بعد از کسب رضایت آگاهانه از آنها از ژانویه 2023 مطالعه پایلوت شروع شده است.
برای مطالعه RCT اصلی ما 1792 بیمار با نسبت توزیع 1:1(896 نفر در هر گروه) و محاسبه کردیم.که با محاسبه 10% ریزش در فالوآپ شرکت کنندگان در مجموع به 1972 نفر واجد شرایط( زن باردار پرخطر) یعنی 986 شرکت کننده در هر گروه نیاز داریم. برای مطالعه پایلوت به 200 بیمار نیاز بود که بعد از غربالگری 1686 زن باردار به این حجم رسیدیم. و بعد از کسب رضایت آگاهانه از آنها از ژانویه 2023 مطالعه پایلوت شروع شده است.
Block Randomization, block with 2 alleles and size6
Group A is the intervention group and B is the control group
Pregnant women who go to the prenatal clinic for pregnancy care are checked for eligibility for the study based on the study criteria. People who meet the study conditions will be candidates for the study. Based on the following blocks, they will be assigned to the intervention or control group, respectively. The intervention group or A will receive aspirin earlier and in the first trimester of pregnancy in the form of packages containing pills that have no name and address and the number of which they should take until the end of pregnancy, and the people who will be assigned to the control group or B according to They receive the routine protocol of aspirin in similar packages for the second trimester of pregnancy.
How to randomly: will be based on random 4 allelic blocks: AABBAA _ AAAABB _BBAAAA _ BBBABA _ BBAABB ....
In the execution method for randomization we use the following site to determine the sequences :
https://www.sealdenvelope.com/simple -randomiser/v1/lists
Block Randomization, block with 2 alleles and size6
Group A is the intervention group and B is the control group
Pregnant women who go to the prenatal clinic for pregnancy care are checked for eligibility for the study based on the study criteria. People who meet the study conditions will be candidates for the study. Based on the following blocks, they will be assigned to the intervention or control group, respectively. The intervention group or A will started aspirin earlier and in the beginning of first trimester of pregnancy , and the participants who will be assigned to the control group or B according to They receive the routine protocol of aspirin in the end of first trimster.
How to randomly: will be based on random 4 allelic blocks: AABBAA _ AAAABB _BBAAAA _ BBBABA _ BBAABB ....
In the execution method for randomization we use the following site to determine the sequences :
https://www.sealdenvelope.com/simple -randomiser/v1/lists
Block Randomization, block with 2 alleles and size6 Group A is the intervention group and B is the control group Pregnant women who go to the prenatal clinic for pregnancy care are checked for eligibility for the study based on the study criteria. People who meet the study conditions will be candidates for the study. Based on the following blocks, they will be assigned to the intervention or control group, respectively. The intervention group or A will receivestarted aspirin earlier and in the beginning of first trimester of pregnancy in the form of packages containing pills that have no name and address and the number of which they should take until the end of pregnancy, and the peopleparticipants who will be assigned to the control group or B according to They receive the routine protocol of aspirin in similar packages for the second trimesterend of pregnancyfirst trimster. How to randomly: will be based on random 4 allelic blocks: AABBAA _ AAAABB _BBAAAA _ BBBABA _ BBAABB .... In the execution method for randomization we use the following site to determine the sequences : https://www.sealdenvelope.com/simple -randomiser/v1/lists
تصادفی سازی بر اساس بلوک های تصادفی-۴ آللی و سایز 6 خواهد بود.
گروهAگروه مداخله و Bکنترل است:
خانمهای باردار ی که برای مراقبتهای بارداری به درمانگاه پره ناتال مراجعه میکنند از نظر واجد شرایط بودن مطالعه بر مبنای معیارهای مطالعه بررسی می شوند.افرادی که شرایط مطالعه را دارند کاندید مطالعه خواهند بود.بر اساس بلوکهای زیر به ترتیب برای گروه مداخله یا کنترل تخصیص داده میشوند.گروه مداخله یا Aآسپیرین را زودتر و در سه ماهه اول بارداری بصورت بسته های حاوی قرص که اسم و نشانی ندارد و به تعدادی که باید تا پایان بارداری مصرف کنند،دریافت می کنندوافرادی که به گروه کنترل یا B تخصیص داده می شوند مطابق پروتکل روتین داروی آسپیرین را در بسته های مشابه برای سه ماهه دوم بارداری دریافت می کنند.
نحوه تصادفی سازی : بر اساس بلوکهای تصادفی 4 آللی خواهد بود.)AABBAA_AAAABB_BBAAAA_AAABAB-BBBABA_BBAABB_......
در روش اجرا جهت تصادفی سازی برای تعیین توالی ها از سایت ذیر استفاده می کنیم:
https://www.sealdenvelope.com/simple -randomiser/v1/lists
تصادفی سازی بر اساس بلوک های تصادفی-۴ آللی و سایز 6 خواهد بود.
گروهAگروه مداخله و Bکنترل است:
خانمهای باردار ی که برای مراقبتهای بارداری به درمانگاه پره ناتال مراجعه میکنند از نظر واجد شرایط بودن مطالعه بر مبنای معیارهای مطالعه بررسی می شوند.افرادی که شرایط مطالعه را دارند کاندید مطالعه خواهند بود.بر اساس بلوکهای زیر به ترتیب برای گروه مداخله یا کنترل تخصیص داده میشوند.گروه مداخله یاA -آسپیرین را زودتر و در سه ماهه اول بارداری شروع میکنند. افرادی که به گروه کنترل یا B -تخصیص داده می شوند مطابق پروتکل روتین داروی آسپیرین را از انتهای تریمستر اول شروع می کنند.
نحوه تصادفی سازی : بر اساس بلوکهای تصادفی 4 آللی خواهد بود.)AABBAA_AAAABB_BBAAAA_AAABAB-BBBABA_BBAABB_......
در روش اجرا جهت تصادفی سازی برای تعیین توالی ها از سایت ذیر استفاده می کنیم:
https://www.sealdenvelope.com/simple -randomiser/v1/lists
تصادفی سازی بر اساس بلوک های تصادفی-۴ آللی و سایز 6 خواهد بود. گروهAگروه مداخله و Bکنترل است: خانمهای باردار ی که برای مراقبتهای بارداری به درمانگاه پره ناتال مراجعه میکنند از نظر واجد شرایط بودن مطالعه بر مبنای معیارهای مطالعه بررسی می شوند.افرادی که شرایط مطالعه را دارند کاندید مطالعه خواهند بود.بر اساس بلوکهای زیر به ترتیب برای گروه مداخله یا کنترل تخصیص داده میشوند.گروه مداخله یا AآسپیرینیاA -آسپیرین را زودتر و در سه ماهه اول بارداری بصورت بسته های حاوی قرص که اسم و نشانی ندارد و به تعدادی که باید تا پایان بارداری مصرف کنند،دریافت می کنندوافرادیشروع میکنند. افرادی که به گروه کنترل یا B -تخصیص داده می شوند مطابق پروتکل روتین داروی آسپیرین را در بسته های مشابه برای سه ماهه دوم بارداری دریافتاز انتهای تریمستر اول شروع می کنند. نحوه تصادفی سازی : بر اساس بلوکهای تصادفی 4 آللی خواهد بود.)AABBAA_AAAABB_BBAAAA_AAABAB-BBBABA_BBAABB_...... در روش اجرا جهت تصادفی سازی برای تعیین توالی ها از سایت ذیر استفاده می کنیم: https://www.sealdenvelope.com/simple -randomiser/v1/lists
The samples assigned to each group receive similar drug packages that contain the same type of drug with the same shape. The time of taking the drug in the two groups is different, and the samples of each group are unaware of the timing of the others. At the end, he records and analyzes the data and is unaware of the type of groups (A-B). Therefore, the study is double-blind.
Due to the nature of the intervention, neither participants nor researchers can be blinded to allocation. However, assessments will be conducted by a blind analyzer for trial allocation.
The samples assignedDue to each group receive similar drug packages that contain the same type of drug with the same shape. The time of taking the drug in the two groups is different, and the samples of each group are unawarenature of the timing of the othersintervention, neither participants nor researchers can be blinded to allocation. At the endHowever, he records and analyzes the data and is unaware of the type of groups (A-B)assessments will be conducted by a blind analyzer for trial allocation. Therefore, the study is double-blind.
نمونه های تخصیص یافته به هر گروه بسته های دارویی مشابه هم که حاوی یک نوع دارو با یک شکل است را دریافت می کنند.زمان مصرف دارو در دو گروه متفاوت است که نمونه های هر دسته از زمانبندی سایرین بی اطلاع است.فردی هم که در پایان داده ها را ثبت و آنالیز می کند از نوع گروهها (A-B) بی اطلاع است .لذا مطالعه دو سو کور می باشد.
به دلیل ماهیت مطالعه نه برای شرکت کنندگان و نه برای محقق مطالعه کور نمی باشد ولی برای ارزیاب و آنالیزور ور است.
نمونه های تخصیص یافته به هر گروه بسته های دارویی مشابه هم که حاوی یک نوع دارو با یک شکل است را دریافت می کنند.زمان مصرف دارو در دو گروه متفاوت است که نمونه های هر دسته از زمانبندی سایرین بی اطلاع است.فردی هم که در پایان داده ها را ثبتدلیل ماهیت مطالعه نه برای شرکت کنندگان و آنالیز می کند از نوع گروهها (A-B) بی اطلاع است .لذانه برای محقق مطالعه دو سو کور مینمی باشد ولی برای ارزیاب و آنالیزور ور است.
Primary outcomes
#1
18 weeks of pregnancy and at the end of pregnancy
The visit intervals of the participants are montly, up to 28 weeks, every two weeks up to 32 weeks, and weekly up to 36 weeks.
18The visit intervals of the participants are montly, up to 28 weeks, every two weeks of pregnancyup to 32 weeks, and at the end of pregnancyweekly up to 36 weeks.
18 هفته بارداری و در انتهای بارداری
فواصل ویزیت شرکت کنندگان ماهانه تا 28 هفته و سپس هر دوهفته تا 32 هفته و سپس هر هفته تا 36 هفته می باشد.
18فواصل ویزیت شرکت کنندگان ماهانه تا 28 هفته بارداریو سپس هر دوهفته تا 32 هفته و در انتهای بارداریسپس هر هفته تا 36 هفته می باشد.
Secondary outcomes
#1
empty
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
empty
محدودیت رشد داخل حمی <5% نیازمند زایمان قبل از 34 و 37 هفته
محدودیت رشد داخل حمی <5% نیازمند زایمان قبل از 34 و 37 هفته
empty
by performing serial biometrics during pregnancy
by performing serial biometrics during pregnancy
empty
با انجام بیومتریهای سریال طی حاملگی
با انجام بیومتریهای سریال طی حاملگی
empty
ulrasound
ulrasound
empty
سونوگرافی
سونوگرافی
#2
empty
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
empty
مردهزایی یا مرگ داخل رحمی د 20 هفته یا بیشتر
مردهزایی یا مرگ داخل رحمی د 20 هفته یا بیشتر
empty
by performing serial ultrasound during pregnancy
by performing serial ultrasound during pregnancy
empty
با سونوهای سریال
با سونوهای سریال
empty
ultrasound
ultrasound
empty
سونوگرافی
سونوگرافی
#3
empty
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
empty
زایمان زودرس خودبخود قبل 34 و 37 هفته
زایمان زودرس خودبخود قبل 34 و 37 هفته
empty
routine visits
routine visits
empty
ویزیت های روتین
ویزیت های روتین
empty
history and examination
history and examination
empty
شرح حال و معاینه
شرح حال و معاینه
#4
empty
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
empty
دیسترس تنفسی نوزاد که نیاز به تجویز سورفاکتانت و تهویه مکانیکی باشد
دیسترس تنفسی نوزاد که نیاز به تجویز سورفاکتانت و تهویه مکانیکی باشد
empty
after the birth
after the birth
empty
بعد از تولد نوزاد
بعد از تولد نوزاد
empty
examination
examination
empty
معاینه نوزاد
معاینه نوزاد
#5
empty
Neonate intensive care unit admission.
Neonate intensive care unit admission.
empty
بستری در NICU
بستری در NICU
empty
After the birth
After the birth
empty
بعد از تولد
بعد از تولد
empty
examination of newborn
examination of newborn
empty
معاینه نوزاد
معاینه نوزاد
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arezoo Behzadian
Full name of responsible person - Persian: آرزو بهزادیان
Position - English: Perinatology Fellowship resident
Position - Persian: دانشجوی فلوشیپ پریناتولوژی
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
Street address - Persian: شهر زیبا-خ سازمان آب-خ نیلوفر ششم شرقی-برجهای دو قلوی میکا-
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1487646987
Phone: +98 21 4614 1652
Mobile: +98 912 430 1658
Fax:
Email: dr.behzadian@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Arezoo Behzadian
Full name of responsible person - Persian: آرزو بهزادیان
Position - English: Perinatology Fellowship resident
Position - Persian: دستیار فلوشیپ پریناتولوژی
Latest degree: specialist
Area of specialty/work: 49
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
Street address - Persian: شهر زیبا-خ سازمان آب-خ نیلوفر ششم شرقی-برجهای دو قلوی میکا-
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1487646987
Phone: +98 21 4614 1652
Mobile: +98 912 430 1658
Fax:
Email: dr.behzadian@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Arezoo Behzadian Full name of responsible person - Persian: آرزو بهزادیان Position - English: Perinatology Fellowship resident Position - Persian: دانشجویدستیار فلوشیپ پریناتولوژی Latest degree: specialist Area of specialty/work: 49 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower Street address - Persian: شهر زیبا-خ سازمان آب-خ نیلوفر ششم شرقی-برجهای دو قلوی میکا- City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1487646987 Phone: +98 21 4614 1652 Mobile: +98 912 430 1658 Fax: Email: dr.behzadian@yahoo.com Web page address:
Protocol summary
Study aim
prevention of occurrence of early and late preeclampsia
Design
Randomized clinical trial.Assessor-blinded. Two intervention groups and control group.
Settings and conduct
At each visit, the presence of edema or preeclampsia symptoms are noted and recorded. In addition, participants are assessed for possible aspirin side effects.
Participants are randomly selected to receive low-dose aspirin, either before 11 weeks’ gestation (optimally from the detection of the fetal heart beat) in the intervention group or after 11 weeks in the control group. The cut-off gestational age to receive aspirin is 16 weeks in the control group. In both groups, the initial dose of aspirin is 80 mg per day. In both groups, aspirin will be continued until 36 weeks or in the case of premature delivery.
At 11_13 weeks and 6 days, when the gestational age is confirmed by an ultrasound study of the CRL measurement through the fetal NT measurement, the UTA-PI of uterine arteries is assessed transabdominally. In addition, a combined test for aneuploidy screening is requested through measuring the maternal serum free β-hcG and PAPP-A.
If there are criteria in both groups including:
PAPP-A < 0.4 in the first trimester or
preeclampsia risk more than or equal1 ̸ 100 to in aneuploidy screening test or
in color doppler ultrasound (the mean UTA-PI>95th percentile or bilateral notching), the initial dose of aspirin, which is 80 mg, is changed to 150 mg per day.
Participants/Inclusion and exclusion criteria
The participants are pregnant women at high-risk for preeclampsia according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria:
mentioned on he previous page.
Intervention groups
intervention group: early start of aspirin
Control group: routine intervention
Main outcome variables
Early and late preeclampsia
General information
Reason for update
Hello, No major change have been made in the process and metodology of the trial,except for subtleties that help the audience to better and secondly,our tudy include two main parts. The first part, which has been approed in this center,is being done and the results will be announced later. And in the from of a pilo study, as well as the feaibility of conducting the main study and solving possible problems and defects on it way, it has started with 200 participants from January 2023. The second part includes the main RCT with the same metodology. For this eason, this request was made to provide a possibility to accelerate the start of the main trial, considering the success of the pilot tudy process for feasibility in he last 6 months. Thank you very much.
Acronym
IRCT registration information
IRCT registration number:IRCT20221126056611N1
Registration date:2023-01-07, 1401/10/17
Registration timing:prospective
Last update:2023-06-10, 1402/03/20
Update count:3
Registration date
2023-01-07, 1401/10/17
Registrant information
Name
Arezoo Behzadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4614 1652
Email address
dr.behzadian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-08, 1401/10/18
Expected recruitment end date
2023-12-08, 1402/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
Public title
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The participants are pregnant women at high-risk for preeclampsia based on demographic characteristics and personal and obstetrics history, according to the ACOG and USPSTF and SMFM guidelines.
Exclusion criteria:
1) Hypersensitivity to nonsteroidal anti-inflammatory drug products
2) Asthma-rhinitis and nasal polyps
3) Sever renal or sever hepatic impairment.
4) History of gastrointestinal bleeding or active peptic ulcer disease
5) vaginal bleeding or significant hematoma on ultrasound.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization, block with 2 alleles and size6
Group A is the intervention group and B is the control group
Pregnant women who go to the prenatal clinic for pregnancy care are checked for eligibility for the study based on the study criteria. People who meet the study conditions will be candidates for the study. Based on the following blocks, they will be assigned to the intervention or control group, respectively. The intervention group or A will started aspirin earlier and in the beginning of first trimester of pregnancy , and the participants who will be assigned to the control group or B according to They receive the routine protocol of aspirin in the end of first trimster.
How to randomly: will be based on random 4 allelic blocks: AABBAA _ AAAABB _BBAAAA _ BBBABA _ BBAABB ....
In the execution method for randomization we use the following site to determine the sequences :
https://www.sealdenvelope.com/simple -randomiser/v1/lists
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, neither participants nor researchers can be blinded to allocation. However, assessments will be conducted by a blind analyzer for trial allocation.
Placebo
Not used
Assignment
Parallel
Other design features
We calculated that the enrollment of 1792 patients in a 1:1 ratio of distribution (896 patients in each group) would provide the trial with a power of 90% (alpha level of 5%). If we allow for a 10% loss to follow-up, the sample size will reach 986 participants in each group. A total of 1972 eligible participants will be randomly entered into the trial arms. We proposed the sample size of 200 high-risk pregnancies for the pilot study and quality control of the center to perform the main RCT. We reached this sample size by screening 1686 pregnant women who referred to Maternal- Fetal Hospital Clinic. After taking written conscious consent, from January 2023, the trial with 100 participants in each group started with a ratio of 1:1, randomly.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
KeshavarzBlvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-10-18, 1401/07/26
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.215
Health conditions studied
1
Description of health condition studied
High Risk Pregnancy for preeclampsia
ICD-10 code
Z35
ICD-10 code description
Supervision of high-risk pregnancy
Primary outcomes
1
Description
Pre-eclampsia: Hypertension with proteinuria occurs for the first time after the 20th week of pregnancy. According to the definition of systolic blood pressure >= 140 mm Hg and diastolic blood pressure >= 90 mm Hg recorded at least during two measurements with an interval of 4 hours, along with one or more of the following that occurred for the first time after 20 weeks. given
Timepoint
The visit intervals of the participants are montly, up to 28 weeks, every two weeks up to 32 weeks, and weekly up to 36 weeks.
Method of measurement
1- Proteinuria: Excretion >=30 mg/mol in the protein/creatinine ratio; or >=300 mg in 24-hour urine; or >=2+ in urine dipstic test.2- Evidence of dysfunction of the organs of the mother's body: including acute kidney damage (creatinine >=1 mg/dL); Liver involvement (increase of transaminases including alanine aminotransferase or aspartate aminotransferase >=40 iu/l); with or without pain in the epigastric region, neurological complications (eclampsia-altered state of consciousness-blurred vision-clonus-severe headache-persistent visual scotoma); or hematological changes (thrombocytopenia-diffuse intravascular coagulopathy-hemolysis).3- Utero-placental dysfunction: such as intrauterine growth restriction, abnormal Doppler of the umbilical artery or fetal death).
Secondary outcomes
1
Description
Incidence of Small for gestational age (<5th centile) requiring delivery at<34 weeks and <37weeks
Timepoint
by performing serial biometrics during pregnancy
Method of measurement
ulrasound
2
Description
Incidence of Stillbirth or Intrauterine Fetal Death (IUFD) at≥20 weeks.
Timepoint
by performing serial ultrasound during pregnancy
Method of measurement
ultrasound
3
Description
Incidence of Spontaneous preterm delivery at<34 weeks and <37weeks
Timepoint
routine visits
Method of measurement
history and examination
4
Description
Respiratory distress syndrome, defined as need for surfactant and ventilation as a result of prematurity.
Timepoint
after the birth
Method of measurement
examination
5
Description
Neonate intensive care unit admission.
Timepoint
After the birth
Method of measurement
examination of newborn
Intervention groups
1
Description
Intervention group: pregnant mothers are at high risk for preeclampsia, who take a low-dose aspirin 80 or 100 mg daily at night, at bedtime, from the beginning of the first trimester. Control group: pregnant mothers are at high risk for preeclampsia, who follow the routine protocol In the second trimester, they will have a low-dose aspirin tablet of 80 or 100 mg at night at bedtime.
Category
Prevention
2
Description
Control group: routine method of prevention of preeclampsia : in this group high risk pregnant mothers for preeclampsia who were randomly placed in this group according to the routine method that exists in the whole word and currently .It means prescribing a daily low dose aspirin pill in the above method starts from the end of the first trimester( from 12 to 14_15 weeks).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Arezoo Behzadian
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2365
Email
dr.behzadian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Ghods st.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8898 7382
Email
RESEARCH@TUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Behzadian
Position
Perinatology Fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Fax
Email
dr.behzadian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Behzadian
Position
perinatology fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Email
dr.behzadian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arezoo Behzadian
Position
perinatology fellowship assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
East 6th Nilofar street _ Sazemane ab street _ Mica Twin Tower
City
Tehran
Province
Tehran
Postal code
1487646987
Phone
+98 21 4614 1652
Email
dr.behzadian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Final Report & Article
When the data will become available and for how long
6 months after the end of study
To whom data/document is available
Family Health Research Institute
Research deputy of University
Under which criteria data/document could be used
As final report and Manuscript
From where data/document is obtainable
Family Health Research Institute
What processes are involved for a request to access data/document
The published article is available to the public. The final report will be provided following the written request