Protocol summary
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Study aim
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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
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Design
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clinical trial with control group; With Parallel groups; Double blinded; randomized; design of 40 patients
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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umbilical artery Doppler; uterine artery Doppler; middle cerebral artery; newborn weight; Apgar score; umbilical cord blood gas
General information
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Reason for update
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Modified approved sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140317017034N9
Registration date:
2019-11-09, 1398/08/18
Registration timing:
prospective
Last update:
2021-05-22, 1400/03/01
Update count:
2
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Registration date
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2019-11-09, 1398/08/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-22, 1398/09/01
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Expected recruitment end date
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2020-08-22, 1399/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Pentoxifiylline administration on placenta circulation and pregnancy out come in Fetal Growth Restriction
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Public title
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Effect of Pentoxifiyllin on Fetal Growth Restriction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
Exclusion criteria:
High risk pregnancy (Multi fetal pregnancy; premature rupture of membrane; overt diabetes mellitus; Renal failure; preterm labor pain; rheumatoid disease eg:Lupus))
Bleeding disorders
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-23, 1398/04/02
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Ethics committee reference number
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IR.SUMS.REC.1398.559
Health conditions studied
1
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Description of health condition studied
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Fetal Growth Restriction
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ICD-10 code
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P05
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ICD-10 code description
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Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
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Description
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Umbilical artery Doppler
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Timepoint
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Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
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Method of measurement
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Ultrasound
2
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Description
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Birth weight
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Timepoint
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After birth
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Method of measurement
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scale
3
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Description
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Appgar score
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Timepoint
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After birth
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Method of measurement
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Metric system
4
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Description
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Mean PH (Acid or Alkaline) of umbilical cord
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Timepoint
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After birth
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Method of measurement
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Blood-gaz-analyzer
5
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Description
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Uterine artery Doppler
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Timepoint
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Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
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Method of measurement
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Ultrasound
6
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Description
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Middle cerebral artery Doppler
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Timepoint
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Doppler ultrasound examination at the beginning of the study and then weekly until the end of the delivery.
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Method of measurement
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Ultrasound
7
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Description
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Mean Carbon dioxide pressure of umbilical cord
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Timepoint
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After birth
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Method of measurement
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Blood-gaz-analyzer
8
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Description
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Mean Oxygen pressure of umbilical cord
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Timepoint
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After birth
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Method of measurement
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Blood-gaz-analyzer
9
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Description
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Mean Carbonic Acid of umbilical cord
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Timepoint
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After birth
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Method of measurement
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Blood-gaz-analyzer
Intervention groups
1
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Description
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Intervention group: Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily until delivery
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo twice a day until delivery made by the Faculty of Pharmacy of Shiraz university of medical sciences.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Participant data file: Information and research data
Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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Participant data file:2019
Ethic form: 2019
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To whom data/document is available
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Participant data file: Researcher & Patient
Ethic form: Patient
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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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.
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Comments
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