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IRCT20210730052014N1 IRCT 2021-10-22 Arak University of Medical Sciences Comparison of the effect of pomegranate juice with sildenafil in the treatment of intrauterine growth restriction Comparison of the effect of pomegranate juice with sildenafil on Doppler ultrasound findings in growth restricted fetus 2021-09-21 anticipated 54 Complete https://irct.ir/trial/58471 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Fetal growth restriction. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: En All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Students and researchers can use the data of this study. Where to obtain: Researchers can contact the study author via email at qaediftm@gmail.com to receive data and information. How to obtain: Request information and data to the author via email qaediftm@gmail.com. Comments:
public fatemeh qaedi
Taleghani Educational Medical Center.,West side of Imam Khomeini Street next to the gas company
Arak Iran (Islamic Republic of) 3816149369 +98 86 3277 4001 qaediftm@gmail.com Arak University of Medical Sciences scientific Fatemeh Qaedi
Taleghani Educational Medical Center.,West side of Imam Khomeini Street next to the gas company
Arak Iran (Islamic Republic of) 3816149369 +98 86 3277 4001 qaediftm@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No underlying diseases gestational age 26 to 32 weeks fetal developmental delay singleton cases willingness to participate in the study no limit no limit Both fetal anomalies and fetal heart problems consumption of antioxidants and special diets O36.5 Maternal care for known or suspected poor fetal growth Treatment - Drugs Treatment - Drugs 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. 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. Fetal growth restriction. Timepoint: At the beginning of the study and then monthly. Method of measurement: 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. Birth weight of the baby. Timepoint: At birth. Method of measurement: Using digital scales. Apgar score. Timepoint: At birth. Method of measurement: cheaklist. Arak University of Medical Sciences Approved 2021-05-09 Ethics committee of Arak University of Medical Sciences Deputy of research and technology.,Payambar Azam University Complex.,Arak University of Medical Sciences Arak Markazi Iran (Islamic Republic of)