Comparison the effect of dexamethazone and promethazin with meperidin in rate of nausea and vomiting, labor pain and duration of labor in women with normal vaginal delivery
The objective of this study is to compared the effect of dexamethazone and promethazin with meperidin in rate of nausea and vomiting, labor pain and duration of labor in women with normal vaginal delivery. This study, clinical trials, double-blind, placebo- control, single center are conducted in Arash women's hospital. Among women with term singleton pregnancies with normal vaginal delivery (with cervical dilatation 4-5 cm) 60 women will randomly participated in this study. Exclusion criteria included mother's weight less than 50 kg or more than 100 kg, use of epidural anesthesia, drug and alcohol abuse, history of allergy to drugs used in the study and pre-eclampsia. Participants will allocated in two equal groups. Group1: 100 mg meperidin with 2cc normal saline/ IM and 8 m gr dexamethazone/IV will injected.Group2: 100mg meperidin with 50 mgr promethazin/IM and 2 cc normal saline/IV will injected. The patients will interviewed by a blinded investigator for rate of nausea and vomiting, labor pain 0,30,90 and 120 min after intervention and duration of labor will recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406021951N4
Registration date:2014-09-17, 1393/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Nasrin Faridi Tazeh-kand
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
nfaridi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of dexamethazone and promethazin with meperidin in rate of nausea and vomiting, labor pain and duration of labor in women with normal vaginal delivery
Public title
Evaluation the effect of dexamethazone and promethazin with meperidin in rate of labor pain and duration of labor in women with normal vaginal delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy with cephalic presentation, gestational age 38 to 42 weeks with an uncomplicated vaginal delivery. Exclusion criteria: mother's weight less than 50 kg or more than 100 kg, use of epidural anesthesia, drug and alcohol abuse, history of allergy to drugs used in the study and pre-eclampsia.
Age
From 74 years old to 52 years old
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
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
1147/130/ص/93
Health conditions studied
1
Description of health condition studied
Normal vaginal delivery
ICD-10 code
z37.0
ICD-10 code description
Single live birth
Primary outcomes
1
Description
Intensity of labor pain
Timepoint
Before intervention and 30,60,90 and 120 min after intervention
Method of measurement
Visual scale
2
Description
Duration of labor
Timepoint
Before intervention and 30,60,90 and 120 min after intervention
Method of measurement
Timer
3
Description
The Rate of nausea and vomiting
Timepoint
Before intervention and 30,60,90 and 120 min after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1:100 mg meperidin with 2cc normal saline/ IM and 8 mgr dexamethazone/IV will injected.
Category
Treatment - Drugs
2
Description
Intervention 2:100mg meperidin with 50 mgr promethazin/IM and 2 cc normal saline/IV will injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Nasrin Faridi Tazeh-kand
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Deputy of Research
Full name of responsible person
Dr Yonesian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Deputy of 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
Arash Women 's Hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Faridi Tazeh-kand
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway,Tehranparse,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arash Women 's Hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Faridi Tazeh-kand
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arash Women 's Hospital,Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Faridi Tazeh-kand
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway,Tehranparse,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
nfaridi@sina.tums.ac
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)