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Comparison of Demitron and promethazin in treatment of hyperemesis gravidarum

Protocol summary

Summary
To compare the efficacy of demitron and promethazin in treatment of hyperemesis gravidarum 60 pregnant women with clinical hyperemesis gravidrum randomly divided to two groups of 30 and after exclude multiple pregnancy ;nonviable pregnancy; concomitant emetogenic pathology, they received promethazin and demitron in double-blind method, after 48hr severity of nausea and vomiting and adverse drug reactions will be assessed within questionnaire and at the end we compare the treatment efficacy and adverse reactions of 2 drugs.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201298862N1
Registration date: 2012-10-09, 1391/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-09, 1391/07/18
Registrant information
Name
Yasamin Mehrolhasani
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1281 4283
Email address
881129005@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences (vice chancellor for research)
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Demitron and promethazin in treatment of hyperemesis gravidarum
Public title
Comparison of Demitron and promethazin in treatment of nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: pregnant women with gestation of 20 weeks or less; dehydration due to nausia and vomiting exclusion criteria: multiple pregnancy; nonviable pregnancy; concomitant emetogenic pathology associated with the symptomatology (hepatitis, gastrointestinal disorder,... )
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Kerman University of Medical Science(vice chancellor for research)
Street address
Tahmasbabad cross
City
Kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
k/90/229

Health conditions studied

1

Description of health condition studied
nausea and vomiting in pregnancy
ICD-10 code
O21.1
ICD-10 code description
Hyperemesis gravidarum with metabolic disturbance

Primary outcomes

1

Description
nausea and vomiting
Timepoint
48 hours after drug beginning
Method of measurement
questionnaire

Secondary outcomes

1

Description
drug adverse reactions
Timepoint
48 hours after drug beginning
Method of measurement
questionnaire

Intervention groups

1

Description
intervention group:Amp demitron 8mg intramuscular q 8 hour for 48 hours
Category
Treatment - Drugs

2

Description
control group:Amp promethazine 25mg intramuscular q 6hour for 48 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Dr yasamin mehrolhasani
Street address
Pajouhesh square, Afzalipour hospital
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences (vice chancellor for research)
Full name of responsible person
Dr Nahid Eftekhari
Street address
Pajouhesh square, Afzalipour hospital
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences (vice chancellor for research)
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
Kerman University of Medical Sciences
Full name of responsible person
Yasamin Mehrolhasani(MD)
Position
Obstetric and Gynecology resident
Other areas of specialty/work
Street address
Pajouhesh square, Afzalipour hospital
City
Kerman
Postal code
Phone
+98 34 1281 4283
Fax
Email
yasamin_m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Scienses
Full name of responsible person
Yasamin Mehrolhasani(MD)
Position
Obstetric and Gynecology resident
Other areas of specialty/work
Street address
Pajouhesh square, Afzalipour hospital
City
Kerman
Postal code
Phone
+98 34 1281 4283
Fax
Email
yasamin_m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Yasamin Mehrolhasani(MD)
Position
Obstetric and Gynecology resident
Other areas of specialty/work
Street address
Pajouhesh square, Afzalipour hospital
City
Kerman
Postal code
Phone
00
Fax
Email
yasamin_m@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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