determination of the effect of ondansetron and metoclopramide on nausea and vomiting of pregnancy
Design
double blind randomised 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.
Settings and conduct
All pregnant women who will be admitted with nausea and vomiting of pregnancy in the obstetrics and maternal ward of Mousavi Hospital in Zanjan will be enrolled and randomly divided into two groups: Endonestrone and Metoclopramide.
Participants/Inclusion and exclusion criteria
Inclusion criteria: clinical signs of nausea, vomiting and dehydration, gestational age less than 16 weeks from the first day of the last menstruation, ketonuria, oral intolerance.
Exclusion criteria: gastrointestinal disorders justify nausea and vomiting, multiple pregnancy, having certain diseases , such as diabetes ,asthma and urinary tract infection and Taking any medicine other than folic acid.
Intervention groups
for the treatment of nausea and vomiting of pregnancy , ondanserone is used in one group and metoclopramid is used in the other group.
Main outcome variables
nausea and vomiting (using PUQE checklist); the number of drug doses and the number of days between the admission and discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043735N1
Registration date:2019-09-30, 1398/07/08
Registration timing:retrospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Fatemeh Moradiha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3357 9389
Email address
moradiha.f@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum
Public title
Comparison of Effectiveness of Ondansetron versus Metoclopramide in Hyperemesis Gravidarum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
clinical signs of nausea , vomiting and dehydration
gestational age <16 weeks from the first day of the last menstruation
ketonuria
oral intolerance
Exclusion criteria:
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
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with coin throwing will be used to divide patients into two groups of study
Blinding (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Azadi square, Islamic Republic BLvd, Central Branch of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
ZUMS.REC.1395.40
Health conditions studied
1
Description of health condition studied
hyperemesis gravidarum
ICD-10 code
O21.1
ICD-10 code description
Hyperemesis gravidarum with metabolic disturbance
Primary outcomes
1
Description
nausea and vomiting
Timepoint
beginning of study and 24 ,48 hours after starting treatment
Method of measurement
questionnaire PUQE (Pregnancy Unique Quantification of Emesis)
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
Intervention groups
1
Description
Intervention group: one , intravenous ondansetrone 4 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance
Category
Treatment - Drugs
2
Description
Intervention group: two , intravenous metoclopramide 10 milligram every 8 hours, from the beginning of the stay until patients find oral tolerance.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi Hospital Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Moradiha
Street address
Road Gavazang, Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
3418734595
Phone
+98 28 3357 9389
Email
moradiha.f@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr alireza shoghli
Street address
Zanjan, Azadi Boulevard, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Fax
+98 24 3342 4770
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Moradiha
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mosavi hospital, gavazang, zanjan
City
Zanjan
Province
Zanjan
Postal code
3418734595
Phone
+98 28 3357 9389
Fax
Email
moradiha.f@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Moradiha
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mosavi hospital, gavazang, zanjan
City
Zanjan
Province
Zanjan
Postal code
3418734595
Phone
+98 28 3357 9389
Fax
Email
moradiha.f@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Moradiha
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mosavi hospital, gavazang, zanjan
City
Zanjan
Province
Zanjan
Postal code
3418734595
Phone
+98 28 3357 9389
Fax
Email
moradiha.f@gmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the information, such as information on the main outcome, can be shared.
When the data will become available and for how long
Start one year's period of access after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
No data analysis is allowed
From where data/document is obtainable
moradiha.f@gmu.ac.ir
What processes are involved for a request to access data/document