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IRCT20140317017034N9 IRCT 2019-11-09 Shiraz University of Medical Sciences Effect of Pentoxifiyllin on Fetal Growth Restriction The effect of Pentoxifiylline administration on placenta circulation and pregnancy out come in Fetal Growth Restriction 2019-11-22 anticipated 40 Complete https://irct.ir/trial/41401 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 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. 3 Fetal Growth Restriction. Intervention 1: Intervention group: Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily until delivery. Intervention 2: Control group: Placebo twice a day until delivery made by the Faculty of Pharmacy of Shiraz university of medical sciences. Yes - There is a plan to make this available What will be shared: Participant data file: Information and research data Ethic form: Complete the ٍEthic form by the patient When: Participant data file:2019 Ethic form: 2019 To whom: Participant data file: Researcher & Patient Ethic form: Patient Conditions: 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. Where to obtain: Participant data file: Obstetrics and gynecology ward Shiraz university of medical sciences Ethic form: Obstetrics and gynecology ward Shiraz university of medical sciences How to obtain: 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. Comments:
public Shohreh Roozme
Maternal- Fetal Medicine (Perinatology)research center; Hafez Hospital; Chamran Ave.,Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 dr.roozmeh1995@yahoo.com Shiraz University of Medical Sciences scientific Homeria Vafaei
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3612 8258 Vafaeih@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 45 years Female High risk pregnancy (Multi fetal pregnancy; premature rupture of membrane; overt diabetes mellitus; Renal failure; preterm labor pain; rheumatoid disease eg:Lupus)) Bleeding disorders P05 Disorders of newborn related to slow fetal growth and fetal malnutrition Treatment - Drugs Placebo Intervention group: Pentoxifylline sustained release tablet 400 mg manufactured by Farabi Pharmaceutical Company twice daily until delivery Control group: Placebo twice a day until delivery made by the Faculty of Pharmacy of Shiraz university of medical sciences. 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. Birth weight. Timepoint: After birth. Method of measurement: scale. Appgar score. Timepoint: After birth. Method of measurement: Metric system. Mean PH (Acid or Alkaline) of umbilical cord. Timepoint: After birth. Method of measurement: Blood-gaz-analyzer. 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. 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. Mean Carbon dioxide pressure of umbilical cord. Timepoint: After birth. Method of measurement: Blood-gaz-analyzer. Mean Oxygen pressure of umbilical cord. Timepoint: After birth. Method of measurement: Blood-gaz-analyzer. Mean Carbonic Acid of umbilical cord. Timepoint: After birth. Method of measurement: Blood-gaz-analyzer. Shiraz University of Medical Sciences Approved 2019-06-23 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)