Comparison Of The Effect Of Ondansetron And Metoclopramide On Nausea And Vomiting Control After Cesarean Section
Design
In this research, 120 pregnant women were chosen purposefully and randomly allocated into two intervention and control groups.
Settings and conduct
The Present Study Was A Clinical Trial On Women Aged 18 to 40 Years Who Were Candidates For Elective Cesarean Section And Referred To Amiralmomenin Hospital In Zabol. A Total Of 120 Mothers Were Randomly Divided Into Two Groups Of 60 Subjects Receiving Ondansetron or Metoclopramide.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women With Singleton Pregnancy; Class 1 Or 2 in ASA Grading; No Prohibition Of Spinal Anesthesia. Exclusion criteria: history of narcotic use; being under anti-nausea treatment; having Gestational Hypertension Within One Week Before Surgery.
Intervention groups
The intervention group included 60 pregnant women underwent cesarean surgery and received Ondansetron 4 milligram, single dose, via infusion.
The Control group included 60 pregnant women underwent cesarean surgery and received Methoclopramide 10 milligram, single dose, via infusion.
Main outcome variables
Nausea and vomiting after cesarean section.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170502033762N2
Registration date:2018-02-22, 1396/12/03
Registration timing:retrospective
Last update:2018-02-22, 1396/12/03
Update count:0
Registration date
2018-02-22, 1396/12/03
Registrant information
Name
saeed mosaed
Name of organization / entity
zbmu.ac.ir
Country
Iran (Islamic Republic of)
Phone
+98 54 3762 7732
Email address
saeed.mosaed@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-05-04, 1395/02/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of The Effects Of Intravenous Metoclopramide And Ondansetron On Prevention Of Nausea And Vomiting After Cesarean Section
Public title
Comparison Of The Effects Of Intravenous Metoclopramide And Ondansetron On Prevention Of Nausea And Vomiting After Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who were undergoing elective cesarean section at the Amir-Almomenin hospital in Zabol
Women aged 18-40 years
Exclusion criteria:
History Of severe Nausea and Vomiting
History Of Severe Dizziness In The Car (motion sickness)
History Of Drug Use
No Anti-Nausea Medicine use
high blood pressure in pregnancy
Ondansetron and Metoclopramide were put in sealed pockets and they were uncovered and the drugs were injected by a technician and therefore patients, researchers and outcome evaluators were blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
Vice chancellor for research, Educational Complex of Zabol University of Medical Sciences, Rajaee Ave
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
zbmu.1.REC.1395.88
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified
Primary outcomes
1
Description
Nausea And Vomiting
Timepoint
Immediately after the intervention, six hours after the intervention, 12 hours after the intervention, 18 hours after the intervention and 24 hours after the intervention.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
Every six hours
Method of measurement
Direct observation by technician and asking from the patient
Intervention groups
1
Description
Intervention group: Ondansetron (produced by Abidi Company) 4 mg in 10 cc normal saline was Infused before surgery.
Category
Treatment - Drugs
2
Description
Control group (routine treatment): Methoclopramide (produced by Abidi Company) 10 mg in 10 cc normal saline was infused before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Saeed Mosaed
Street address
No 11, Forrokhi dormitory, Motahari 16 Ave, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Phone
+98 54 3762 7732
Email
mosaedsaeed1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Saeed Mosaed
Street address
No 11, Forrokhi dormitory, Motahari 16 Ave, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Phone
+98 54 3762 7732
Email
mosaedsaeed1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Saeed Mosaed
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Forrokhi dormitory, Motahari 16, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Phone
+98 54 3762 7732
Fax
Email
mosaedsaeed1372@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Saeed Mosaed
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Forrokhi dormitory, Motahari 16, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Phone
+98 54 3762 7732
Fax
Email
Mosaedsaeed1372@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Saeed Mosaed
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Forrokhi dormitory, Motahari 16, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9951645984
Phone
+98 54 3762 7732
Fax
Email
mosaedsaeed1372@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The Reason For The Confidentiality Of The Information Of The Participants In The Plan