The purpose of this study is to compare the effects of three doses of oxytocin on uterine tonicity and hemodynamic variables of women undergoing cesarean section under spinal anesthesia.60 patients randomly receive three different doses of oxytocin (infusion of 10 ,40 and 80 units in 1 hour) during surgery .Uterine tonicity is evaluated 5 and 15 minutes after infusion of oxytocin .Systolic , diastolic and mean arterial pressures measure before and then every 5 minutes after administration of oxytocin. Uterine tonicity and blood oressure compare betwween the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203102963N6
Registration date:2012-04-18, 1391/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of three doses of oxytocin on uterine tonicity and mother,s hemodynamic variables during Caesarean delivery
Public title
Comparison of the effects of three doses of Uterine retractor on uterine tonicity and mother,s blood pressure during Caesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I ,18-35 years, singleton full term pregnant women candidate for caesarean delivery because of previous caesarean delivery
exclusion criteria:active labour ,ruptured membranes ,known drug allergy to oxytocin ,multiple gestation ,significant obstetric disease (including preeclampsia, eclampsia ),BMI>35 ,known risk factors for postpartum haemorrhage ( including abnormal placentation , multiple gestation , uterine fibroids ) coagulation disorder , and thrombocytopenia .
Age
From 18 years old to 35 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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2011-09-13, 1390/06/22
Ethics committee reference number
78749
Health conditions studied
1
Description of health condition studied
oxytocin
ICD-10 code
O61.0
ICD-10 code description
Failed medical induction of labour
Primary outcomes
1
Description
Uterine tonicity
Timepoint
5 and 15 minutes after administration of oxytocin
Method of measurement
clinical evaluation and related score
2
Description
systolic blood pressure
Timepoint
every 2 minutes from administration of oxytocin to end of surgery
Method of measurement
blood pressure monitoring device
3
Description
diastolic blood pressure
Timepoint
every 2 minutes from administration of oxytocin to end of surgery
Method of measurement
blood pressure monitoring device
4
Description
heart rate
Timepoint
every 2 minutes from administration of oxytocin to end of surgery
Method of measurement
electrocardiography monitoring
Secondary outcomes
empty
Intervention groups
1
Description
oxytocin 10 units/hour during surgery
Category
Treatment - Drugs
2
Description
40 units oxytocin /hour during surgery
Category
Treatment - Drugs
3
Description
80 units oxytocin / hour during surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr.Shekoufeh Behdad
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr. Hasan Mozaffari
Full name of responsible person
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Hasan Mozaffari
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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant of professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Shekoufeh Behdad
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4101
Fax
Email
drbehdad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)