Protocol summary
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Study aim
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Comparison of the effect of pomegranate juice with sildenafil on Doppler ultrasound findings in fetuses with growth retardation 26 to 32 weeks
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Design
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This randomized clinical trial with phase 3 parallel groups will be performed on 54 patients with 26 to 32 weeks fetal growth retardation.
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Settings and conduct
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In this randomized clinical trial study, 54 pregnant women with 26 to 32 weeks gestation with growth retarded fetuses referred to gynecology clinics in the third trimester of pregnancy will be selected by availability. The effect of sildenafil and pomegranate juice on the disorder Intrauterine growth will be monitored.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include no underlying diseases, gestational age 26 to 32 weeks and fetuses with growth retardation, singleton cases and willingness to participate in the study. Exclusion criteria also include fetal anomalies and fetal heart problems and the use of antioxidants and special diets .
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Intervention groups
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One group is given 230 ml of pomegranate juice (equivalent to 8 ounces) daily (20) for up to 6 weeks, in addition to taking the necessary steps mentioned in the obstetrics and gynecology texts (such as taking aspirin).
The second group will receive 25 mg of sildenafil 3 tablets daily for 6 weeks and will receive the same care as the first group and aspirin.
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Main outcome variables
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Doppler ultrasound findings in fetuses with growth retardation;PI umbilical arteryPI; uterine artery;Birth weight of the baby;Apgar score of the baby
General information
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Reason for update
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Adding FEW as a primary outcome and announcing the completion of the clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210730052014N1
Registration date:
2021-10-22, 1400/07/30
Registration timing:
registered_while_recruiting
Last update:
2023-07-03, 1402/04/12
Update count:
1
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Registration date
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2021-10-22, 1400/07/30
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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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2021-09-21, 1400/06/30
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Expected recruitment end date
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2022-01-20, 1400/10/30
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Actual recruitment start date
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2021-09-21, 1400/06/30
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Actual recruitment end date
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2021-12-22, 1400/10/01
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Trial completion date
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2022-05-20, 1401/02/30
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Scientific title
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Comparison of the effect of pomegranate juice with sildenafil on Doppler ultrasound findings in growth restricted fetus
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Public title
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Comparison of the effect of pomegranate juice with sildenafil in the treatment of intrauterine 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:
No underlying diseases
gestational age 26 to 32 weeks
fetal developmental delay
singleton cases
willingness to participate in the study
Exclusion criteria:
fetal anomalies and fetal heart problems
consumption of antioxidants and special diets
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
54
Actual sample size reached:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be allocated into two groups using a permuted balanced block randomization method with the size of blocks 4 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Concealment is also guaranteed due to the use of permuted balanced block randomization method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The person in charge of statistical analysis will be unaware of the type of intervention performed in the groups and will analyze the data without knowing the type of group allocation.
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Placebo
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Not 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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2021-05-09, 1400/02/19
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Ethics committee reference number
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IR.ARAKMU.REC.1400.023
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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O36.5
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ICD-10 code description
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Maternal care for known or suspected poor fetal growth
Primary outcomes
1
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Description
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Fetal growth restriction
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Timepoint
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At the beginning of the study and then monthly
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Method of measurement
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Changes in umbilical artery PI, uterine artery PI, and estimated fetal weight (FEW) in both groups are monitored and compared monthly by a female resident alongside a perinatologist and radiologist with a Medison device.
Secondary outcomes
1
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Description
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Birth weight of the baby
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Timepoint
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At birth
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Method of measurement
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Using digital scales
2
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Description
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Apgar score
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Timepoint
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At birth
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Method of measurement
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cheaklist
Intervention groups
1
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Description
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One group, in addition to performing the necessary measures given in the obstetrics and gynecology texts (such as advising to rest, ensuring a proper diet, and receiving aspirin), is given 230 ml of pomegranate juice (equivalent to 8 ounces) daily for up to 6 weeks. It will be provided to patients weekly in calibrated containers for 7 days.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: The second group will receive 25 mg of sildenafil 3 tablets daily for 6 weeks and will receive the same care as the first group and aspirin.
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Category
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Treatment - Drugs
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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Arak 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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En All data is potentially shareable after unidentified individuals
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When the data will become available and for how long
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Access period starts 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Students and researchers can use the data of this study.
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From where data/document is obtainable
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Researchers can contact the study author via email at qaediftm@gmail.com to receive data and information.
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What processes are involved for a request to access data/document
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Request information and data to the author via email qaediftm@gmail.com.
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Comments
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