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Efficacy of tranexamic acid in reducing blood loss and intra and postoperative complications in patients with placenta accrete spectrum

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History
# Registration date Revision Id
2 2021-07-11, 1400/04/20 190054
1 2020-10-26, 1399/08/05 156214
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  • Protocol summary

    Patients are randomly divided into tranexamic acid and placebo groups. Randomization is done using the random block method. Saline or tranexamic acid-containing syringes are prepared by an anesthesiologist who is aware of patient grouping but has no role in intraoperative or postoperative management. Also, participants, caregivers and the person analyzing the results will not know about the grouping of patients. During and after surgery, blood loss is closely monitored and Hemoglobin levels are constantly monitored. Blood transfusion if Hemoglobin level drops below 8 gm / dl, and advanced transfusion protocol is performed if blood loss exceeds 1000 ml, in which case one Fresh frozen plasma(FFP) unit and one platelet unit with each Packed red blood cells(pRBCs) transfer unit It will be given.
    Patients are randomly divided into tranexamic acid and placebo groups. Randomization is done using the random block method. Saline or tranexamic acid-containing syringes are prepared by an anesthesiologist who is aware of patient grouping but has no role in intraoperative or postoperative management. Also, participants, caregivers and the person analyzing the results will not know about the grouping of patients.
    بیماران به طور تصادفی در دو گروه ترانگزامیک اسید و پلاسبو تقسیم می شوند. تصادفی سازی با استفاده از روش بلوک تصادفی انجام می شود. سرنگ های حاوی سالین یا ترانگزامیک اسید توسط متخصص بیهوشی که از گروه بندی بیماران اطلاع دارد اما در مدیریت حین عمل یا بعد از عمل نقشی نخواهد داشت آماده می شوند. همچنین شرکت کنندگان، مراقبت کنندگان و فرد آنالیز کننده نتایج از گروه بندی بیماران اطلاعی نخواهد داشت. در طول عمل و بعد از عمل، از دست دادن خون به دقت بررسی می شود و سطح هموگلوبین دائماً اندازه گیری می شود. ترانسفیوژن خون در صورتی انجام می شود که سطح هموگلوبین به کمتر از gm/dl 8 کاهش یابد، و پروتکل ترانسفیوژن پیشرفته زمانی انجام می شود که از دست دادن خون بیش از ml 1000 باشد که در این صورت یک واحد پلاسمای منجمد تازه(FFP) و یک واحد پلاکت با هر واحد گلبول های قرمز خون بسته بندی شده (pRBCs) انتقال داده می شود.
    بیماران به طور تصادفی در دو گروه ترانگزامیک اسید و پلاسبو تقسیم می شوند. تصادفی سازی با استفاده از روش بلوک تصادفی انجام می شود. سرنگ های حاوی سالین یا ترانگزامیک اسید توسط متخصص بیهوشی که از گروه بندی بیماران اطلاع دارد اما در مدیریت حین عمل یا بعد از عمل نقشی نخواهد داشت آماده می شوند. همچنین شرکت کنندگان، مراقبت کنندگان و فرد آنالیز کننده نتایج از گروه بندی بیماران اطلاعی نخواهد داشت.
    Age over 18 years Diagnosis of placenta accrete spectrum syndrome on ultrasound Any normal pregnancy (single, twin, etc.) Cesarean section or hysterectomy Patient consent to participate in the study
    Inclusion criteria: Age over 18 years, Diagnosis of placenta accrete syndrome on ultrasound, singleton pregnancy, Cesarean section or hysterectomy, Patient consent to participate in the study; Exclusion criteria: history of cardiovascular diseases, history of the bleeding disorder, liver and kidney disease, known coagulation disorders, anemia preoperatively, thrombocytopenia, history of preeclampsia or eclampsia in the current pregnancy, and contraindication to TXA use
    سن بالای 18 سال تشخیص سندرم جفت اکرتا در سونوگرافی هرگونه بارداری معمول (تک قلو، دوقلو و غیره) سزارین یا سزارین هیسترکتومی رضایت بیمار برای شرکت در مطالعه
    معیارهای ورود به مطالعه: سن بالای 18 سال، تشخیص سندرم جفت اکرتا در سونوگرافی، بارداری تک قلو، سزارین یا سزارین هیسترکتومی رضایت بیمار برای شرکت در مطالعه؛ معیارهای خروج از مطالعه: سابقه بیماری های قلبی عروقی، سابقه اختلالات خونریزی، بیماری کبدی و کلیوی، اختلالات انعقادی شناخته شده، آنمی قبل از عمل، ترومبوسیتوپنی، سابقه اکلامپسی یا پره اکلامپسی در حاملگی جاری، کنترااندیکاسیون برای مصرف ترانگزامیک اسید
    Intervention group: Patients in this group receive 1 gram of intravenous tranexamine within 10 minutes immediately after birth and umbilical cord ligation. Control group: Patients in this group receive 50 mL of normal saline after umbilical cord ligation
    Intervention group: Patients in this group receive 1 gram of intravenous tranexamine within 10 minutes immediately after birth and umbilical cord ligation. Control group: Patients in this group receive 50 mL of normal saline after umbilical cord ligation
    گروه مداخله: بیماران در این گروه 1 گرم ترانگزامیک داخل وریدی در طول 10 دقیقه بلافاصله بعد از تولد نوزاد و بستن بند ناف دریافت می کنند. گروه کنترل: بیماران این گروه بعد از بستن بند ناف mL 50 نرمال سالین دریافت می کنند.
    گروه مداخله: بیماران در این گروه 1 گرم ترانگزامیک داخل وریدی در طول 10 دقیقه بلافاصله بعد از تولد نوزاد و بستن بند ناف دریافت می کنند. گروه کنترل: بیماران این گروه بعد از بستن بند ناف mL 50 نرمال سالین دریافت می کنند.
    During and after surgery, blood loss is closely monitored and Hemoglobin levels are constantly monitored.
    Amount of estimated blood loss (EBL) during and after surgery, amount of blood products transfusion, complications during and after delivery and duration of hospitalization
    در طول عمل و بعد از عمل، از دست دادن خون به دقت بررسی می شود و سطح هموگلوبین دائماً اندازه گیری می شود.
    از دست دادن خون (EBL) حین و بعد از عمل، میزان ترانسفیوژن محصولات خونی، عوارض حین و بعد از عمل و مدت بستری در بیمارستان

  • General information

    25
    23
    empty
    Changing sample size and study outcomes, modifying inclusion and exclusion criteria
    empty
    تغییر حجم نمونه و پیامدهای مطالعه، اصلاح معیارهای ورود و خروج از مطالعه
    age over 18 years
    diagnosis of placenta accrete spectrum syndrome on ultrasound
    any normal pregnancy(singleton , twin , ...)
    cesarean section or cesarean section hysterectomy
    patient consent to participate in the study
    Age over 18 years
    Diagnosis of placenta accrete spectrum syndrome on ultrasound
    Singleton pregnancy
    Cesarean section or cesarean section hysterectomy
    Patient consent to participate in the study
    سن بالای 18 سال
    تشخیص سندرم جفت اکرتا در سونوگرافی
    هرگونه بارداری معمول (تک قلو، دوقلو و غیره)
    سزارین یا سزارین هیسترکتومی
    رضایت بیمار برای شرکت در مطالعه
    سن بالای 18 سال
    تشخیص سندرم جفت اکرتا در سونوگرافی
    بارداری تک قلو
    سزارین یا سزارین هیسترکتومی
    رضایت بیمار برای شرکت در مطالعه
    History of cardiovascular diseases including coronary artery disease, myocardial infarction, severe arrhythmias, and congestive heart failure
    history of the bleeding disorder including antiphospholipid syndrome (APS)
    liver and kidney disease
    known coagulation disorders
    anemia preoperatively (hemoglobin level < 8 mg/dl)
    history of preeclampsia or eclampsia in the current pregnancy
    contraindication to TXA use (history of TXA allergy, venous thromboembolism, active thrombolytic diseases, acquired color vision disorders, history of seizure, pre-known hematuria, and renal failure
    سابقه بیماری های قلبی عروقی از جمله بیماری عروق کرونر، MI، آریتمی های شدید، CHF
    سابقه اختلال خونریزی از جمله سندرم آنتی فسفولیپید (APS)
    بیماری کبدی و کلیوی
    اختلالات انعقادی شناخته شده
    آنمی قبل از عمل (سطح هموگلوبین کمتر از mg/dl 8)
    سابقه اکلامپسی یا پره اکلامپسی در حاملگی جاری
    کنترااندیکاسیون برای مصرف ترانگزامیک اسید (سابقه آلرژی به TXA، سابقه ترومبوامبولیسم وریدی، اختلالات اکتسابی در دید رنگی، سابقه اختلال تشنج، هماچوری شناخته شده از قبل، سابقه نارسایی کلیوی)
    The present study will be performed as a double-blind clinical trial on patients undergoing cesarean section with a diagnosis of placenta accrete spectrum in Imam Khomeini Hospital in Ahvaz in 1399. After obtaining written consent, eligible patients are randomly divided into two groups. This study will be carried out after approval by the Research Ethics Committee of the Vice Chancellor for Research of Ahwaz Jundishapur University of Medical Sciences. All eligible individuals are selected according to the inclusion and exclusion criteria and after providing explanations by the researchers about the purpose and manner of implementation of the project, and enter the study with informed and written consent. Also in this study, the provisions of the ethics statement in Helsinki research and the principles of patient information confidentiality will be observed.
    The present study will be performed as a double-blind clinical trial on patients undergoing cesarean section with a diagnosis of placenta accrete spectrum in Imam Khomeini Hospital in Ahvaz in 1399. After obtaining written consent, eligible patients are randomly divided into two groups. Syringes containing TXA or normal saline will prepared by an anesthesiologist who knew the groupings but had no role in intraoperative or postoperative management. Also, participants and caregivers will be blinded to the grouping and interventions
    مطالعه حاضر به صورت کارآزمایی بالینی دو سوکور بر روی بیماران تحت سزارین با تشخیص سندروم جفت اکرتا در بیمارستان امام خمینی اهواز در سال 1399 اجرا خواهد شد. پس از کسب رضایت نامه کتبی بیماران واجد شرایط به صورت تصادفی به دو گروه تقسیم می شوند. این مطالعه پس از تائید در کمیته اخلاق در پژوهش معاونت پژوهشی دانشگاه علوم پزشکی جندی شاپور اهواز انجام خواهد شد. تمامی افراد واجد شرایط با توجه به معیارهای ورود و خروج از مطالعه و پس از ارائه توضیحات از سوی محققان در خصوص هدف و نحوه اجرای طرح مورد نظر انتخاب و با اخذ رضایت آگاهانه و کتبی وارد مطالعه می شوند. همچنین در این مطالعه مفاد بیانیه اخلاق در پژوهش هلسینکی و اصول محرمانگی اطلاعات بیمار رعایت خواهد شد.
    مطالعه حاضر به صورت کارآزمایی بالینی دو سوکور بر روی بیماران تحت سزارین با تشخیص سندروم جفت اکرتا در بیمارستان امام خمینی اهواز در سال 1399 اجرا خواهد شد. پس از کسب رضایت نامه کتبی بیماران واجد شرایط به صورت تصادفی به دو گروه تقسیم می شوند. سرنگ های حاوی سالین یا TXA توسط متخصص بیهوشی که از گروه بندی بیماران اطلاع دارد اما در مدیریت حین عمل یا بعد از عمل نقشی ندارد آماده می شوند. همچنین شرکت کنندگان، مراقبت کنندگان و فرد آنالیز کننده نتایج از گروه بندی بیماران اطلاعی نخواهند داشت.

  • Primary outcomes

    #1
    EBL
    Amount of estimated blood loss (EBL)
    #2
    empty
    complications during and after delivery
    empty
    عوارض حین و بعد از زایمان
    empty
    Evaluating the patient during and after delivery
    empty
    ارزیابی بیمار حین و بعد از زایمان
    empty
    Incidence of complications during and after delivery such as rupture of the bowel, need for hysterectomy, hypogastric ligation, need for laparotomy, and rupture of the bladder
    empty
    بروز عوارض حین و بعد از زایمان از جمله شامل پارگی روده، نیاز به هیسترکتومی، هیپوگاستریک لیگاسیون، نیاز به لاپاراتومی، پارگی مثانه و مرگ

  • Secondary outcomes

    #1
    empty
    need to blood products transfusion
    empty
    نیاز به ترانسفیوژن محصولات خونی
    empty
    during the surgery and the first 24 h after delivery
    empty
    حین عمل و 24 ساعت ابتدایی بعد از زایمان
    empty
    Amount of received PRBCs, amount of received platelets, and amount of received FFP
    empty
    مقدار PRBC دریافت شده، مقدار پلاکت دریافت شده، مقدار FFP دریافت شده
    #2
    empty
    duration of hospitalization
    empty
    مدت بستری در بیمارستان
    empty
    Number of hospitalization days after delivery
    empty
    تعداد روزهای بستری در بیمارستان بعد از عمل زایمان
    empty
    Number of hospitalization days
    empty
    تعداد روزهای بستری در بیمارستان

  • Recruitment centers

    #1
    Name of recruitment center - English: Ahwaz Imam Khomeini educational and Medical Center
    Name of recruitment center - Persian: مرکز آموزشی درمانی امام خمینی اهواز
    Full name of responsible person - English: kobra shojaei
    Full name of responsible person - Persian: کبرا شجاعی
    Street address - English: azadegan st.
    Street address - Persian: آزادگان
    City - English: ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6111111111
    Phone: +98 61 3292 3985
    Fax:
    Email: amir_fattah2000@yahoo.com
    Web page address:
    Name of recruitment center - English: Ahwaz Imam Khomeini Educational and Medical Center
    Name of recruitment center - Persian: مرکز آموزشی درمانی امام خمینی اهواز
    Full name of responsible person - English: Kobra Shojaei
    Full name of responsible person - Persian: کبرا شجاعی
    Street address - English: Azadegan St.
    Street address - Persian: آزادگان
    City - English: Ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6111111111
    Phone: +98 61 3292 3985
    Fax:
    Email: amir_fattah2000@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr mehdi ahmadi moghadam
    Full name of responsible person - Persian: دکتر مهدی احمدی مقدم
    Street address - English: golestan ave.
    Street address - Persian: بلوار گلستان
    City - English: ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6111111111
    Phone: +98 61 3336 7548
    Fax:
    Email: amir_fattah2000@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Mehdi Ahmadi Moghadam
    Full name of responsible person - Persian: دکتر مهدی احمدی مقدم
    Street address - English: Golestan Ave.
    Street address - Persian: بلوار گلستان
    City - English: Ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6111111111
    Phone: +98 61 3336 7548
    Fax:
    Email: amir_fattah2000@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of tranexamic acid in reducing bleeding and complications during and after surgery in patients with placenta accrete spectrum syndrome
Design
Patients are randomly divided into tranexamic acid and placebo groups. Randomization is done using the random block method. Saline or tranexamic acid-containing syringes are prepared by an anesthesiologist who is aware of patient grouping but has no role in intraoperative or postoperative management. Also, participants, caregivers and the person analyzing the results will not know about the grouping of patients.
Settings and conduct
The present study will be performed as a double-blind clinical trial on patients undergoing cesarean section with a diagnosis of placenta accrete spectrum in Imam Khomeini Hospital in Ahvaz in 2020-2021.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Diagnosis of placenta accrete syndrome on ultrasound, singleton pregnancy, Cesarean section or hysterectomy, Patient consent to participate in the study; Exclusion criteria: history of cardiovascular diseases, history of the bleeding disorder, liver and kidney disease, known coagulation disorders, anemia preoperatively, thrombocytopenia, history of preeclampsia or eclampsia in the current pregnancy, and contraindication to TXA use
Intervention groups
Intervention group: Patients in this group receive 1 gram of intravenous tranexamine within 10 minutes immediately after birth and umbilical cord ligation. Control group: Patients in this group receive 50 mL of normal saline after umbilical cord ligation
Main outcome variables
Amount of estimated blood loss (EBL) during and after surgery, amount of blood products transfusion, complications during and after delivery and duration of hospitalization

General information

Reason for update
Changing sample size and study outcomes, modifying inclusion and exclusion criteria
Acronym
IRCT registration information
IRCT registration number: IRCT20201003048909N1
Registration date: 2020-10-26, 1399/08/05
Registration timing: retrospective

Last update: 2021-07-12, 1400/04/21
Update count: 1
Registration date
2020-10-26, 1399/08/05
Registrant information
Name
kobra shojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 9635
Email address
amir_fattah2000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of tranexamic acid in reducing blood loss and intra and postoperative complications in patients with placenta accrete spectrum
Public title
Efficacy of tranexamic acid in reducing blood loss in patients with placenta accrete spectrum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Diagnosis of placenta accrete spectrum syndrome on ultrasound Singleton pregnancy Cesarean section or cesarean section hysterectomy Patient consent to participate in the study
Exclusion criteria:
History of cardiovascular diseases including coronary artery disease, myocardial infarction, severe arrhythmias, and congestive heart failure history of the bleeding disorder including antiphospholipid syndrome (APS) liver and kidney disease known coagulation disorders anemia preoperatively (hemoglobin level < 8 mg/dl) history of preeclampsia or eclampsia in the current pregnancy contraindication to TXA use (history of TXA allergy, venous thromboembolism, active thrombolytic diseases, acquired color vision disorders, history of seizure, pre-known hematuria, and renal failure
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 23
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into Intervention group and control groups. Randomization is done using the random block method. Intervention group: Patients in this group receive 1 gram of intravenous tranexamine within 10 minutes immediately after birth and umbilical cord ligation. Control group: Patients in this group receive 50 mL of normal saline after umbilical cord ligation. Saline or tranexamic acid -containing syringes are prepared by an anesthesiologist who is aware of patient grouping but has no role in intraoperative or postoperative management. Also, participants, caregivers and the person analyzing the results will not know about the grouping of patients. During and after surgery, blood loss is closely monitored and Hb levels are constantly monitored. Blood transfusion if Hb level drops below 8 gm / dl, and advanced transfusion protocol is performed if blood loss exceeds 1000 ml, in which case one FFP unit and one platelet unit with each pRBC transfer unit It will be given. If necessary, this meaning is transferred to the ICU
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study will be performed as a double-blind clinical trial on patients undergoing cesarean section with a diagnosis of placenta accrete spectrum in Imam Khomeini Hospital in Ahvaz in 1399. After obtaining written consent, eligible patients are randomly divided into two groups. Syringes containing TXA or normal saline will prepared by an anesthesiologist who knew the groupings but had no role in intraoperative or postoperative management. Also, participants and caregivers will be blinded to the grouping and interventions
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapoor University of Medical Sciences
Street address
Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6811111111
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.AJUMS.REC.1399.485

Health conditions studied

1

Description of health condition studied
Placenta accrete spectrum
ICD-10 code
O43.21
ICD-10 code description
Placenta accreta

Primary outcomes

1

Description
Amount of estimated blood loss (EBL)
Timepoint
Before and after surgery
Method of measurement
CC blood lost

2

Description
complications during and after delivery
Timepoint
Evaluating the patient during and after delivery
Method of measurement
Incidence of complications during and after delivery such as rupture of the bowel, need for hysterectomy, hypogastric ligation, need for laparotomy, and rupture of the bladder

Secondary outcomes

1

Description
need to blood products transfusion
Timepoint
during the surgery and the first 24 h after delivery
Method of measurement
Amount of received PRBCs, amount of received platelets, and amount of received FFP

2

Description
duration of hospitalization
Timepoint
Number of hospitalization days after delivery
Method of measurement
Number of hospitalization days

Intervention groups

1

Description
Intervention group: Patients in this group will receive 1 gram of intravenous tranexamic acid brand TRANEXIP® made by Caspian Tamin Pharmaceutical Company during 10 minutes immediately after the birth of the baby and cord closure.
Category
Treatment - Drugs

2

Description
Control group: Patients in this group receive 50 mL normal saline after birth and umbilical cord closure made by Iranian Pharmaceutical and Injectable Products Company. Syringes containing normal saline or tranexamic acid are prepared by an anesthesiologist who is knowledge of the patients' grouping but will not play a role in the management during or after surgery. Also, participants, carers and the person analyzing the results will not know the grouping of patients. Blood transfusion is performed if hemoglobin levels are reduced to less than 8 gm/dl, and advanced transfusion protocol is performed when blood loss exceeds 1000 ml, in which case a unit of fresh frozen plasma (FFP) and a platelet unit with each unit of packed red blood cells (pRBCs) are transferred. Patients will be transferred to the Intensive Care Unit (ICU) if needed
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahwaz Imam Khomeini Educational and Medical Center
Full name of responsible person
Kobra Shojaei
Street address
Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 61 3292 3985
Email
amir_fattah2000@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadi Moghadam
Street address
Golestan Ave.
City
Ahwaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 61 3336 7548
Email
amir_fattah2000@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Kobra Shojaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 61 3292 3985
Email
amir_fattah2000@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kobra Shojaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 61 3292 3589
Email
amir_fattah2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Saberi Behbahani
Position
Medical Student(Resident)
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini Hospital, Azadegan St.
City
Ahwaz
Province
Khouzestan
Postal code
6111111111
Phone
+98 61 3338 9635
Email
amir_fattah2000@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
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
All data from this study can be published
When the data will become available and for how long
Start access from the time the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of the present study can be used in any situation and anywhere
From where data/document is obtainable
Dr maryam saberi behbahani e mail: amir_fattah2000@yahoo.com cell tel : 00989161911268
What processes are involved for a request to access data/document
Correspond or contact the person in charge of providing the documentation
Comments
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