A comparison of various bolus doses of intravenous oxytocin on intraoperative hemodynamic changes and drug side effects in elective cesarean section under spinal anesthesia
Purpose: Comparing the effects of various bolus doses of oxytocin after delivery on hemodynamic changes and drug side effects in elective cesarean section. Inclusion criteria: Healthy pregnant women without any underlying disease who have been planned to undergo elective cesarean section to give birth to a single live newborn. Exclusion criteria: 1) failed spinal anesthesia and need to general anesthesia 2)block level higher than T4 3) atonia of uterine 4)surgical complication leading to sever & acute bleeding 5) duration of surgery more than 1 hour 6) administration any uterotonic drug d 7) blood transfusion 8) macrosomia 9) polyhydroamnious. Method: a clinical trial on 120 elective cesarean section. The study is explained for the patients and written consent is obtained. A peripheral blood sample was taken at the preoperative visit to determine hemoglobin level. After spinal anesthesia and giving birth to baby by cesarean section infusion of 20 units of oxytocin in 1 liter of normal saline is started at a rate of 10 ml per minute. At the same time in group 1ml placebo bolus, in group 2 , 2 unit oxytocin bolus and in group 3 , 5 unit oxytocin bolus is administered. Hemodynamic parameters are measured before and 1,3,5.10 minutes after oxytocin and at the end of operation. At the end of surgery we ask the patient about headache and vomiting. Hemoglobin level is checked again after 24 hours of the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112138391N1
Registration date:2012-01-07, 1390/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-07, 1390/10/17
Registrant information
Name
Mehrsima Abdollahzadeh
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2021
Email address
abdollahzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gilan University of Medical Sciences
Expected recruitment start date
2010-12-12, 1389/09/21
Expected recruitment end date
2011-12-12, 1390/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of various bolus doses of intravenous oxytocin on intraoperative hemodynamic changes and drug side effects in elective cesarean section under spinal anesthesia
Public title
A comparison of various bolus doses of intravenous oxytocin on intraoperative hemodynamic changes in elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy pregnant women without any underlying disease who have been planned to undergo elective cesarean section to give birth to a single live newborn. Exclusion criteria included: 1) failure of spinal anesthesia and need to general anesthesia; 2) block level higher than T4; 3) atonia of uterine during or after surgery; 4) surgical complication leading to sever & acute bleeding; 5) duration of surgery more than 1 hour; 6) administration any uterotonic drug during or after surgery; 7) need to blood transfusion during & after transfusion; 8) macrosomia; 9) polyhydroamnious.
Age
From 15 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Gilan University of Medical Sciences
Street address
Namjoo street
City
Rasht
Postal code
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
1891193707
Health conditions studied
1
Description of health condition studied
obstetric conditions
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Survey hemodynamic changes
Timepoint
Before drug administraion & 1min, 3min, 5min & 10 min
Method of measurement
Manual manometer & stethoscope& digital monitiring
Secondary outcomes
1
Description
Blood hemoglobin
Timepoint
Before & 24 hours after surgery
Method of measurement
H1 automatic device
2
Description
Headache
Timepoint
During surgery, after prescription
Method of measurement
Asking patient
3
Description
Vomiting
Timepoint
During surgery, after prescription
Method of measurement
Asking patient
Intervention groups
1
Description
prescription of 1ml water for injection in addition of infusion of oxytocin after delivery during cesarean section in control group
Category
Placebo
2
Description
prescription of 2 units oxytocin bolus in addition of infusion of this drug after delivery during cesarean section in intervention group
Category
Treatment - Drugs
3
Description
prescription of 5 units oxytocin bolus in addition of infusion of this drug after delivery during cesarean section in intervention group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital, Rasht
Full name of responsible person
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abdollahzadeh, Mehrsima MD
Full name of responsible person
Abdollahzadeh, Mehrsima MD
Street address
Reproductive Health research center, Alzahra hospital, Namjo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abdollahzadeh, Mehrsima MD
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
Guilan University of Medical Sciences
Full name of responsible person
Abdollahzadeh, Mehrsima MD
Position
Assistant professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health Research Center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
abdollahzadeh@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Abdollahzadeh, Mehrsima MD
Position
Assistant professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Reproductive Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
abdollahzadeh@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Dalil Heirati
Position
B.S Midfiwe
Other areas of specialty/work
Street address
Reproductive Health research center, Alzahra hospital, Namjo street
City
Rasht
Postal code
Phone
Fax
Email
h_fertility@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)