Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000166471
Ethics application status
Approved
Date submitted
21/08/2015
Date registered
10/02/2016
Date last updated
8/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of intravenous oxytocin on lung haemodynamics and gas exchange during caesarean section under general and spinal anaesthesia
Scientific title
Impact of intravenous oxytocin on lung haemodynamics and gas exchange during caesarean section under general and spinal anaesthesia
Secondary ID [1] 287246 0
None
Universal Trial Number (UTN)
U1111-1173-0232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oxygen saturation during caesarean section under general and spinal anaesthesia 295861 0
Condition category
Condition code
Anaesthesiology 296111 296111 0 0
Anaesthetics
Reproductive Health and Childbirth 297676 297676 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study involves patients scheduled for elective caesarean section under spinal (group 1) and general anaesthesia (group 2). All of the patients will be managed by the standard, routine spinal and general anaesthesia methods and will be monitored by the standard methods (pulse oximetry, ECG electrodes, non-invasive blood pressure). After clamping and cutting of the umbilical cord, 10 I.U. of synthetic oxytocin (the dose of oxytocin requested by the obstetrician due to the low uterine tone intraoperatively) will be given intravenously as a bolus and 10 I.U. of oxytocin will be given as an infusion through 3 minutes in all of the patients. Any changes in oxygen saturation after intravenous application of oxytocin, as well as the changes in pulse and mean arterial pressure (MAP) will be recorded.
Intervention code [1] 292538 0
Not applicable
Comparator / control treatment
Concerning the reduction of the bleeding of the uterus during caesarean section by administering oxytocin intravenously, both groups of patients (those undergoing elective caesarean section under spinal anaesthesia (group 1) and those undergoing elective caesarean section under general anaesthesia (group 2)) are treated the same: 10 I.U. of oxytocin intravenously as a bolus and 10 I.U. of oxytocin in infusion. Oxygen saturation, MAP and pulse are being compared between the two groups. Each group of patients implies standard treatment because both spinal and general anaesthesia are considered as legitimate and standard methods of providing anaesthesia for caesarean section, as well as the doses of oxytocin given to both groups. The two groups are mutually compared as the goal of the study is to quantify the potential impact of oxytocin on lung haemodynamics and consequently on oxygen saturation in both groups, as well as the possible difference in oxygen saturation between the two groups.
Control group
Active

Outcomes
Primary outcome [1] 295786 0
changes in oxygen saturation after apllication of intravenous oxytocin by pulse oximetry
Timepoint [1] 295786 0
Period after intravenous application of oxytocin until the end of the surgical procedure (caesarean section)
Secondary outcome [1] 316519 0
changes in mean arterial pressure (MAP) by non-invasive blood presurre and pulse by pulse oximetry after intravenous application of oxytocin
Timepoint [1] 316519 0
period after intravenous application of oxytocin until the end of the surgical procedure (caesarean section)

Eligibility
Key inclusion criteria
Patients scheduled for elective caesarean section
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients receiving standard doses of oxytocin (5 IU as a bolus plus 5 IU in infusion through 3 minutes) and patients receiving larger doses of oxytocin (>20 IU intraoperatively).
Underlying lung disease (asthma, COPD)
Preeclampsia, hypertension
Intraoperative blood loss above 800 ml

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using MedCalc Software version 12.1.3. (Mariakerke, Belgium). X2 test will be used to compare categorical variables. Numerical variables will be tested for the normality of distribution using Kolmogorov-Smirnov test and presented as mean +/- standard deviation or median (interquartile range) as appropriate. t test will be used to compare normally distributed variables, while nonparametric Mann-Whitney U-test to compare data that will not meet normal distribution. A P value <0.05 will be considered as significant. The sample size was calculated due to difference of means and standard deviations with alpha 0.05 (type I error) and beta 0.20 (type II error). For the study to have 90% power at P<0.05, a sample of 35 patients per group was required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/08/2015
Date of last participant enrolment
Anticipated
Actual
30/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 7109 0
Croatia
State/province [1] 7109 0
Zagreb

Funding & Sponsors
Funding source category [1] 291882 0
Hospital
Name [1] 291882 0
Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb
Country [1] 291882 0
Croatia
Primary sponsor type
Hospital
Name
Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb
Address
Petrova 13, 10000 Zagreb, Croatia, European Union
Country
Croatia
Secondary sponsor category [1] 290548 0
None
Name [1] 290548 0
Address [1] 290548 0
Country [1] 290548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293395 0
Ethical Committe of the Obstetrics and Gynecology Clinic
Ethics committee address [1] 293395 0
Ethics committee country [1] 293395 0
Croatia
Date submitted for ethics approval [1] 293395 0
01/04/2015
Approval date [1] 293395 0
23/04/2015
Ethics approval number [1] 293395 0
021-1/54-2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59410 0
Dr Kresimir Reiner
Address 59410 0
Kresimir Reiner
Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb
Petrova 13
10000 Zagreb
Croatia
Country 59410 0
Croatia
Phone 59410 0
+385917615364
Fax 59410 0
Email 59410 0
[email protected]
Contact person for public queries
Name 59411 0
Kresimir Reiner
Address 59411 0
Kresimir Reiner
Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb
Petrova 13
10000 Zagreb
Croatia
Country 59411 0
Croatia
Phone 59411 0
+385917615364
Fax 59411 0
Email 59411 0
[email protected]
Contact person for scientific queries
Name 59412 0
Kresimir Reiner
Address 59412 0
Kresimir Reiner
Obstetrics and Gynecology Clinic, Clinical Hospital Center Zagreb
Petrova 13
10000 Zagreb
Croatia
Country 59412 0
Croatia
Phone 59412 0
+385917615363
Fax 59412 0
Email 59412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.