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IRCT20230930059563N1 IRCT 2023-12-30 Kashan University of Medical Sciences The effect of melatonin in the prevention of preeclampsia Investigating of the adjuvant effect of melatonin in the prevention of preeclampsia in moderate and high risk women 2023-11-26 anticipated 60 Complete https://irct.ir/trial/73965 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be using random allocation in blocks of 6. Thus, in each block of 6, 3 patients will be in the intervention group and 3 patients will be in the control group. At the beginning of block selection, patients are selected by simple random method using random numbers until the chance of accepting the patient in the block is 100%, in which case patients are selected in that group to complete the block, Blinding description: Both groups will receive the drugs in the same packaging, size and box. The codes will remain with one of the colleagues of the research project and will be decoded at the end of the study. None of the presenters and patients know the type of codes of each patient until after the data analysis, thus this study is conducted in a triple blind manner. 2-3 Preeclampsia. Intervention 1: Intervention group: Aspirin + melatonin. Intervention 2: Control group: Aspirin. Yes - There is a plan to make this available What will be shared: Age, body mass index, blood pressure, baby weight, number of pregnancies, nationality, education, gestational age at arrival, gestational age at delivery, treatment group, type of delivery, occurrence of pre-eclampsia, baby Apgar, baby height, baby head circumference When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Use for the purpose of meta-analyses is allowed. In other matters, it is necessary to obtain permission from the owner of the license. Where to obtain: Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan Obstetrics and Gynecology Group 00983155589444 How to obtain: Call or send a request to the Obstetrics and Gynecology Department of Kashan University of Medical Sciences Comments:
public Mozhgan Alishahi
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5558 9338 alishahimozhgan@gmail.com Kashan University of Medical Sciences scientific مرضیه طالبیان
Hekmat 55 Alley, Qutb Rawandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 talebianm861@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) 16 years and older 12-28 weeks of pregnancy moderate to high risk of preeclampsia based on US Preventive Services Task Force criteria informed consent 16 years no limit Female Multiple pregnancy Current or previous use of melatonin in the past 6 weeks Allergy to melatonin and aspirin Use of any of the following drugs that can interfere with the metabolism and/or elimination of melatonin: fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors. Carbamazepine, rifampicin and other CYP1A2 inducers. and zalplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics. lose to follow-up non cooperate The presence of any disease or condition that is a contraindication for continued pregnancy Fetal anomaly O14.9 Unspecified pre-eclampsia Prevention Prevention Intervention group: Aspirin + melatonin Control group: Aspirin Occurrence of preeclampsia. Timepoint: The time interval until the occurrence of pre-eclampsia or termination of pregnancy, whichever is earlier. Method of measurement: Based on clinical examination. Type of delivery. Timepoint: Once upon a time. Method of measurement: clinical basis. Neonate Apgar. Timepoint: Once at the moment of the birth. Method of measurement: Based on the Apgar scoring system. Newborn characteristics (height-weight). Timepoint: Once at the moment of the birth. Method of measurement: Based on the standard method of measuring the height and weight of the baby. Kashan University of Medical Sciences Approved 2023-09-10 Ethics committee of Kashan University of Medical Sciences Hekmat 55 Street, Qutb Rawandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)