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Protocol summary
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 80 patients
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 40 patients
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 8040 patients
کارآزمایی بالینی دارای گروه کنترل؛ با گروه های موازی؛ دو سویه کور؛ تصادفی شده؛ طراحی شده در 80 بیمار
کارآزمایی بالینی دارای گروه کنترل؛ با گروه های موازی؛ دو سویه کور؛ تصادفی شده؛ طراحی شده در 40 بیمار
کارآزمایی بالینی دارای گروه کنترل؛ با گروه های موازی؛ دو سویه کور؛ تصادفی شده؛ طراحی شده در 8040 بیمار
Intervention group: 40 patients will be treated by Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily from beginning of study up to delivery time.
control group: will be received placebo manufactured by Shiraz pharmacy school with the same method.
Intervention group: 20 patients will be treated by Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily from beginning of study up to delivery time.
control group: will be received placebo manufactured by Shiraz pharmacy school with the same method.
Intervention group: 4020 patients will be treated by Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily from beginning of study up to delivery time. control group: will be received placebo manufactured by Shiraz pharmacy school with the same method.
گروه مداخله: 40 نفر از بیماران تحت درمان با قرص پنتوکسیفیلین پیوسته رهش 400 میلی گرم ساخت شرکت دارویی فارابی دو بار در روز از زمان مراجعه تا زمان زایمان قرار می گیرند .
گروه کنترل: داروی پلاسبو ساخته شده توسط دانشکده داورسازی شیراز به صورت مشابه مورد استفاده قرار می گیرد.
گروه مداخله: 20 نفر از بیماران تحت درمان با قرص پنتوکسیفیلین پیوسته رهش 400 میلی گرم ساخت شرکت دارویی فارابی دو بار در روز از زمان مراجعه تا زمان زایمان قرار می گیرند .
گروه کنترل: داروی پلاسبو ساخته شده توسط دانشکده داروسازی شیراز به صورت مشابه مورد استفاده قرار می گیرد.
گروه مداخله: 4020 نفر از بیماران تحت درمان با قرص پنتوکسیفیلین پیوسته رهش 400 میلی گرم ساخت شرکت دارویی فارابی دو بار در روز از زمان مراجعه تا زمان زایمان قرار می گیرند . گروه کنترل: داروی پلاسبو ساخته شده توسط دانشکده داورسازیداروسازی شیراز به صورت مشابه مورد استفاده قرار می گیرد.
General information
sample size changing
Modified approved sample size
Modified approved sample size changing
تغییر حجم نمونه
اصلاح حجم نمونه تایید شده
تغییراصلاح حجم نمونه تایید شده
Protocol summary
Study aim
Our purpose is to evaluate the effect of pentoxifylline on placenta perfusion by serial Doppler ultrasound assessment of umbilical and uterine arteries and middle cerebral artery
Design
clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 40 patients
Settings and conduct
Patient with fetal growth restriction and abnormal uterine ; umbilical and middle cerebral artery Doppler index who are referred to hospitals affiliated Shiraz University of medical sciences underwent weekly Doppler ultrasound evaluation by one expert perinatalogist, who is blinded to the study design. Each Doppler is recorded and will compare in 2 groups.
Also, the Apgar score, fetal birth weight, and umbilical cord blood gas analysis will compare in both groups at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with age under 45 Y/o, Gestational age between 26-34 weeks Women with fetal growth restriction and abnormal Doppler finding in uterine; umbilical and middle cerebral artery.
Exclusion criteria: high risk pregnancy (Multi fetal pregnancy; premature rupture of membrane; overt diabetes mellitus; Renal failure); Bleeding disorders
Intervention groups
Intervention group: 20 patients will be treated by Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily from beginning of study up to delivery time.
control group: will be received placebo manufactured by Shiraz pharmacy school with the same method.
The effect of Pentoxifiylline administration on placenta circulation and pregnancy out come in Fetal Growth Restriction
Public title
Effect of Pentoxifiyllin on Fetal Growth Restriction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with age under 45 Y/o
Gestational age between 26-34 weeks
Women with fetal growth restriction and abnormal finding in uterine or umbilical artery Doppler with stage 1, 2
Randomization method: use the block; Randomization unit: Individual; Randomization tool: Minitab Statistical software; How to Build a Sequence: Using randomized blocks, block size: 4; Concealment method: Using similar bottles
Blinding (investigator's opinion)
Double blinded
Blinding description
Pentoxifiylline and placebo have been administered in the similar bottles, so patients and researchers were unable to detect which one was Pentoxifiylline or placebo. Our nurse colleague in this study in Hafez hospital delivered formulations to the participants of the study according to the randomized block table. She was unaware of the content of the bottles. The researcher had no information about formulation used by each patient while visiting them. At the end of the study, the formulations were decoded and the patients assigned to each group were identified.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SUMS.REC.1398.559
Health conditions studied
1
Description of health condition studied
Fetal Growth Restriction
ICD-10 code
P05
ICD-10 code description
Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
Description
Umbilical artery Doppler
Timepoint
Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
Method of measurement
Ultrasound
2
Description
Birth weight
Timepoint
After birth
Method of measurement
scale
3
Description
Appgar score
Timepoint
After birth
Method of measurement
Metric system
4
Description
Mean PH (Acid or Alkaline) of umbilical cord
Timepoint
After birth
Method of measurement
Blood-gaz-analyzer
5
Description
Uterine artery Doppler
Timepoint
Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
Method of measurement
Ultrasound
6
Description
Middle cerebral artery Doppler
Timepoint
Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
Method of measurement
Ultrasound
7
Description
Mean Carbon dioxide pressure of umbilical cord
Timepoint
After birth
Method of measurement
Blood-gaz-analyzer
8
Description
Mean Oxygen pressure of umbilical cord
Timepoint
After birth
Method of measurement
Blood-gaz-analyzer
9
Description
Mean Carbonic Acid of umbilical cord
Timepoint
After birth
Method of measurement
Blood-gaz-analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily until delivery
Category
Treatment - Drugs
2
Description
Control group: Placebo twice a day until delivery made by the Faculty of Pharmacy of Shiraz university of medical sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Shoreh Roozme
Street address
Hafez Clinic; Shahid Chamran blvd
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8257
Email
dr.roozmeh1995@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Yoones Ghasemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shohreh Roozme
Position
Fellow ship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology)research center; Hafez Hospital; Chamran Ave.,Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
dr.roozmeh1995@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Homeria Vafaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
Vafaeih@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohre Roozme
Position
Fellow ship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3612 8258
Email
dr.roozmeh1995@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant data file: Information and research data
Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
Participant data file:2019
Ethic form: 2019
To whom data/document is available
Participant data file: Researcher & Patient
Ethic form: Patient
Under which criteria data/document could be used
Participant data file: participant's or legal guardian's are permitted for awareness of the results.
Ethic form: participant's or legal guardian's are permitted for awareness of the results.
From where data/document is obtainable
Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
What processes are involved for a request to access data/document
Participant data file: Refer to Maternal Fetal medicine Research Center, request for result information.
Ethic form: Refer to Maternal Fetal medicine Research Center, request for result information.