Hyperemesis gravidarum (HG) is defined as nausea and vomiting in pregnancy, typically in the first trimester, resulting in dehydration and ketonuria severe enough to justify hospital admission and require intravenous fluid therapy. The purpose of this study is to compare Granisetron and Promethazine in control of Hyperemesis Gravidarum. A total of 120 female patients who will enter the study will get the treatment dose of drugs (Promethazine and Granisetron) in each group. In the first day of treatment, the patients will receive the I.V. form of drugs in order to tolerate the oral diet. After 48 hours, they will be checked for controlling the nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108144927N2
Registration date:2011-08-16, 1390/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-16, 1390/05/25
Registrant information
Name
Ashraf Alyasin
Name of organization / entity
Tehran University of Medical Sciences, Dr. Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2421
Email address
alyasina@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Aburaihan Pharmaceutical Company
Expected recruitment start date
2011-02-01, 1389/11/12
Expected recruitment end date
2012-08-01, 1391/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey and comparison of the efficacy of Granisetron and Promethazine in control of Hyperemesis Gravidarum
Public title
Survey and comparison of the efficacy of Granisetron and Promethazine in control of Hyperemesis Gravidarum
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the women in the 20 weeks of pregnancy; referred to gynecology and obstetrics emergency room in Dr.Shariati hospital; inappropriate response to outpatient antiemetic therapies; presenting more than one plus ketonuria in complete analysis of urine; nausea and vomiting score more than 13 (according to the pregnancy unique qualification of emesis) and signing the study written consent.
Exclusion criteria: molar pregnancy and sever thyroid or liver disease
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd.,Ghods St.
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
965/130
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
Timepoint
48 hours
Method of measurement
Physical examination
2
Description
Vomoting
Timepoint
48 hours
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Tab Promethazine 25mg qid (I.V. form in the first day of treatment)
Category
Treatment - Drugs
2
Description
Tab Granisetron 1mg bid (I.V. form in the first day of treatment)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Ashraf Alyasin
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Aburaihan Pharmaceutical Company
Full name of responsible person
Dr. Hashem
Street address
Teharnpars St., Damavand Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Aburaihan Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dr. Shariati Teaching Hospita
Full name of responsible person
Dr. Ashraf Alyasin
Position
Faculty member
Other areas of specialty/work
Street address
North of Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 2421
Fax
Email
alyasina@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ashraf Alyasin
Position
Faculty member
Other areas of specialty/work
Street address
North of Karegar St.
City
Tehran
Postal code
Phone
+98 21 8490 2421
Fax
Email
alyasina@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Hassan Torkamandi
Position
Pharmaceutical Care Department Researcher
Other areas of specialty/work
Street address
North of Karegar St.
City
Tehran
Postal code
Phone
+98 21 8490 2364
Fax
Email
htorkamandi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)