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IRCT20190528043735N1 IRCT 2019-09-30 Zanjan University of Medical Sciences Comparison of Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum Comparison of Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum 2019-06-05 anticipated 154 Complete https://irct.ir/trial/39856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with coin throwing will be used to divide patients into two groups of study, Blinding description: in this study, the patient and, investigator and analyst of the data are not prescriptive an any treatment group.In this double-blind, randomized clinical trial of 154 patients randomly will be divided into two groups of 77 patients by coin throwing and accidental drug administration to patients by a third party(nurse) that does not directly play a role in conducting the study.Since both drugs are colorless, patients are not aware of the type of injectable drug, and only the nurse is aware of the prescription drug, and the patients are classified into two groups of one and two. 3 hyperemesis gravidarum. Intervention 1: Intervention group: one , intravenous ondansetrone 4 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance. Intervention 2: Intervention group: two , intravenous metoclopramide 10 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome, can be shared. When: Start one year's period of access after printing the results To whom: Researchers working in academia and academia Conditions: No data analysis is allowed Where to obtain: moradiha.f@gmu.ac.ir How to obtain: Send an email requesting data receipt Comments:
public Fatemeh Moradiha
Mosavi hospital, gavazang, zanjan
Zanjan Iran (Islamic Republic of) 3418734595 +98 28 3357 9389 moradiha.f@gmu.ac.ir Gonabad University of Medical Sciences scientific Fatemeh Moradiha
Mosavi hospital, gavazang, zanjan
Zanjan Iran (Islamic Republic of) 3418734595 +98 28 3357 9389 moradiha.f@gmu.ac.ir Gonabad University of Medical Sciences Iran (Islamic Republic of) clinical signs of nausea , vomiting and dehydration gestational age <16 weeks from the first day of the last menstruation ketonuria oral intolerance no limit no limit Female gastrointestinal disorders justify nausea and vomiting multiple pregnancy having certain diseases, such as diabetes, asthma and urinary tract infection taking any medicine other than folic acid O21.1 Hyperemesis gravidarum with metabolic disturbance Treatment - Drugs Treatment - Drugs Intervention group: one , intravenous ondansetrone 4 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance Intervention group: two , intravenous metoclopramide 10 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance. Nausea and vomiting. Timepoint: beginning of study and 24 ,48 hours after starting treatment. Method of measurement: questionnaire PUQE (Pregnancy Unique Quantification of Emesis). Duration of intravenous fluid intake. Timepoint: from start to end of treatment. Method of measurement: review patient medical records and calculate the hours of intake of fluids. Number of intravenous doses received. Timepoint: from start to end of treatment. Method of measurement: review patient medical records and calculate the number of doses of medication received. Length of hospitalization. Timepoint: from start to end of treatment. Method of measurement: review patient medical records and calculate the number of hospita admissions days. Zanjan University of Medical Sciences Approved 2016-05-04 Ethics committee of Zanjan University of Medical Sciences Azadi square, Islamic Republic BLvd, Central Branch of Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)