Nausea and vomiting are present in 50-90% of pregnancy. Sever form of the disease with 5% loss of body weight can cause morbidity during pregnancy. This study evaluates Ondansetron and Metoclopromide for treatment of nausea and vomiting in pregnancy. One hundred pregnant women enroll the study according to inclusion and exclusion criteria. Following laboratory tests will be checked for them: TSH, BG & RH, CBC, LFT, FBS, Na-K, BUN, Cr and urine Ketone. They will receive 10mg of Metoclopramide or 2mg of Ondansetron two times a day. The severity of nausea and the number of vomiting episodes will be recorded in the last 24 hours before and during treatment and again after one week of cessation of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902161760N6
Registration date:2010-05-06, 1389/02/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-06, 1389/02/16
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Ondansetron vs. Metoclopramide for treatment of nausea and vomiting in pregnancy
Public title
A comparison of Ondansetron vs. Metoclopramide for treatment of nausea and vomiting in pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with gestational age less than 16 weeks based on the last menstrual period and ultrasound, with symptoms of vomiting for more than three times a day, or weight loss more than three kilograms or positive urine ketones. Exclusion criteria: presence of internal diseases at the same time, and hydatidiform mole and twin pregnancy.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
4717641367
Approval date
2010-07-03, 1389/04/12
Ethics committee reference number
1017
Health conditions studied
1
Description of health condition studied
Severe nausea and vomiting of pregnancy
ICD-10 code
O21
ICD-10 code description
Excessive vomiting in pregnancy
Primary outcomes
1
Description
Improvement of clinical symptoms
Timepoint
Before and after treatment
Method of measurement
Based on VAS
Secondary outcomes
1
Description
Recurrence rate of nausea and vomiting
Timepoint
One week after discontinuation
Method of measurement
Based on VAS
Intervention groups
1
Description
Metoclopramide (10mg)
Category
Treatment - Drugs
2
Description
Ondansetron (2mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad Hospital
Full name of responsible person
Marziyeh Zanganeh
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Gangafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
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
Fatemehzahra Fertility & Reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com , zahra@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & Reproductive Health Reseach Center
Full name of responsible person
Dr. Zahra Basirat
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1223 4651
Email
zahra_basirat@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible of Reseach Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & Reproductive Health Reseach Center, Noshirvani steert
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)