the purpose of this study was to compare the effect of three different doses of oxytocin infusion on hemodynamic changes in cesarean delivery . in this randomised double blinded clinical trial study 120 patients age 18-35 years old and BMI 20-35 by American Society of Anesthesia (ASA) physical status I underwent for non emergency repeated cesarean delivery under spinal anesthesia were divided in 3 groups and then each group received 10 or 40 or 80 units of oxytocin infusion after delivery. Systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and heart rate at 30 seconds before oxytocin infusion and each 5 minutes to 30 minutes after that was recorded. blood loss and received serum, uterine tone 5 and 15 minutes after placenta removal, nausea and vomiting were recorded in a questionnaire too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407082963N18
Registration date:2014-08-11, 1393/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-11, 1393/05/20
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
vice chancellor of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of three different doses of oxytocin infusion on hemodynamic changes in cesarean delivery
Public title
Effect of three different doses of oxytocin infusion on hemodynamic changes in cesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
included criteria: all Patients age 18-35 years old and BMI 20-35 by American Society of Anesthesia (ASA) physical status I underwent for non emergency repeated cesarean delivery under spinal anesthesia.
excluded criteria: BMI>35; chronic hypertension; placenta previa; placenta precrata; placenta abruption; placental collaps; gestational age <28 weeks; polyhydroamnious; thrombocytopenia (plt<70000); risk factors of bleeding and history of tocolytic drugs and Aspirin use.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
N/A
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
Ethical Committee of Shahid Sadoughi University of Medical Sciences
Street address
Yazd, Bahonar square
City
Yazd
Postal code
Approval date
2012-08-25, 1391/06/04
Ethics committee reference number
73894/1/17/پ
Health conditions studied
1
Description of health condition studied
hemodynamic changes in cesarean delivery
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
diastolic blood pressure
Timepoint
30 seconds before oxytocin infusion and each 5 minutes to 30 minutes after the that
Method of measurement
by sphygmomanometer
2
Description
systolic blood pressure
Timepoint
30 seconds before oxytocin infusion and each 5 minutes to 30 minutes after the that
Method of measurement
by sphygmomanometer
3
Description
heart rate
Timepoint
30 seconds before oxytocin infusion and each 5 minutes to 30 minutes after the that
Method of measurement
by sphygmomanometer
4
Description
mean arterial blood pressure
Timepoint
30 seconds before oxytocin infusion and each 5 minutes to 30 minutes after the that
Method of measurement
by sphygmomanometer
Secondary outcomes
1
Description
uterine tone
Timepoint
5 to 15 minutes after placenta removal
Method of measurement
by physical exam
2
Description
nausia and vomiting
Timepoint
after awarness of patient
Method of measurement
by direct asking
Intervention groups
1
Description
case group 1: oxytocin 10 units
Category
Treatment - Drugs
2
Description
case group 2: oxytocin 40 units
Category
Treatment - Drugs
3
Description
case group 3: oxytocin 80 units
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Shekofeh Behdad
Street address
Shahid Sadoughi Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Hassan Mozaffari
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
vice chancellor of Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Shekofeh Behdad
Position
associate professor, Depatment of anestesiology
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
8915887857
Phone
+98 35 1822 4000
Fax
Email
behdad90@gmail.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
Dr Shekoufeh Behdad
Position
associate professor, Deparment of Anesthesiology
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
8915887857
Phone
+98 35 1822 4000
Fax
Email
behdad90@gmail.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
Dr Shekoufeh Behdad
Position
associate professor, Department of Anesthesiology
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
8915887857
Phone
+98 35 1822 4000
Fax
Email
behdad90@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)