]>
IRCT20201028049169N2 IRCT 2021-03-17 Tehran University of Medical Sciences Comparison of the effect of phenobarbital on the need for blood transfusion and neonatal phototherapy in mothers with IUT Comparison of the effect of phenobarbital on the need for blood transfusion and neonatal phototherapy in mothers with IUT 2021-04-19 anticipated 38 Complete https://irct.ir/trial/54668 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation rule: First, 19 letters A and 19 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A or B are determined by a lot, Blinding description: This study is performed as single-blind, the pediatric (who assess neonatal jaundice and phototherapy indication), do not know the type of treatment. 3 Fetal anemia. Intervention 1: Intervention group: In the interventional group, 30 mg phenobarbital produced with Marham Daru pharmaceutical co. (two 15 milligram tabs every 8 hours) is prescribed for ten days. According to the time of delivery that is forecasted by the gynecologist, in 10 days till delivery, this drug is prescribed for the pregnant woman. Intervention 2: Control group: In the control group, no additional measures are done and the placebo is not applied. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified participants When: After manuscript published To whom: No limitations Conditions: The data is only available to the project manager, Dr. Fatemeh Rahimi Sharbaf, and any analysis must be done with her opinion. Where to obtain: Fatemeh Rahimi Sharbaf How to obtain: Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Fatemeh Rahimi Sharbaf. Comments:
public Fatemeh Rahimi Sharbaf
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 rahimish@sina.tums.ac.ir Tehran University of Medical Sciences scientific Fatemeh Rahimi Sharbaf
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
Tehran Iran (Islamic Republic of) 1597856511 +98 21 8608 9089 rahimish@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Pregnant women with 17 to 35 gestational age and negative RH Fetus with positive RH and alloimmunization and anemia diagnosis Perinatal indication for intra uterine transfusion no limit no limit Female Existence of any kind of anomaly in the fetus O36.8291 Fetal anemia and thrombocytopenia, unspecified trimester, fetus 1 Treatment - Drugs Treatment - Drugs Intervention group: In the interventional group, 30 mg phenobarbital produced with Marham Daru pharmaceutical co. (two 15 milligram tabs every 8 hours) is prescribed for ten days. According to the time of delivery that is forecasted by the gynecologist, in 10 days till delivery, this drug is prescribed for the pregnant woman. Control group: In the control group, no additional measures are done and the placebo is not applied. Neonatal jaundice. Timepoint: Once. Method of measurement: Pediatric examination and Transcutaneous bilirubinometer. Tehran University of Medical Sciences Approved 2020-12-05 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St Tehran Tehran Iran (Islamic Republic of)