The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000056291
Ethics application status
Approved
Date submitted
26/08/2017
Date registered
17/01/2018
Date last updated
17/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of obstetric care by the type of anaesthesia for caesarean section
Scientific title
Quality of obstetric care by the type of anaesthesia for caesarean section at a tertiary care hospital: a retrospective analysis
Secondary ID [1] 292701 0
None
Universal Trial Number (UTN)
U1111-1201-0854
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section 304457 0
Condition category
Condition code
Anaesthesiology 303793 303793 0 0
Other anaesthesiology
Reproductive Health and Childbirth 303794 303794 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 all patients undergoing caesarean section under general, spinal or epidural anaesthesia. All of the patients are managed by standard, routine anaesthesia methods and monitored by standard methods. Standard monitored data will be recorded for all patients: age, weight, height, BMI, parity, gestational weeks, indication for C-section, urgency category of C-section, type and dose of drugs used and experience level of staff involved. For cases of conversion of regional to general anaesthesia additional variables observed are time between regional anaesthesia applications and general anaesthesia, as well as number of top-ups. Participants are observed until discharge from the ICU or PACU.
Intervention code [1] 298942 0
Not applicable
Comparator / control treatment
Only one group of patients was included in the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303157 0
The composite primary outcome is the rate of general anesthesia, rate of regional anesthesia and rate of conversions from regional to general anaesthesia for caesarean section which are all together considered (by the reccommendations of RCOG) as being parameters of the quality of obstetric care. The mentioned outcome will be assesed by the review of medical records.
Timepoint [1] 303157 0
C-section incision time
Secondary outcome [1] 338056 0
Variable difference between C-sections in successful and failed epidural anaesthesia is assesed by the medical record, i.e. if in the same patient, both epidural and general anesthesia were used, then is obvious to conclude that these are the cases of failed epidural anesthesia (because there was a necessity to induce general anesthesia, despite the fact that epidural anesthesia was already applied in the particular patient).
Timepoint [1] 338056 0
C-section incision time

Eligibility
Key inclusion criteria
Patients who underwent C-section
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Incomplete data for type of anaesthesia used.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Participants are all women who underwent C-section in our clinic in a three-year period. Statistical analysis will be done on a Mac computer using SPSS software version 23. For differences in demographical variables between patients undergoing C-section in general, regional or conversions of regional to general anaesthesia a One-way ANOVA test will be used. For differences in demographical variables between patients who underwent successful or failed epidural anaesthesia t-test will be used. For comparison of nominal variables (experience level of staff, urgency categories) Chi square test will be used. In all tests, p<0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9156 0
Croatia
State/province [1] 9156 0

Funding & Sponsors
Funding source category [1] 297341 0
Hospital
Name [1] 297341 0
Department for Anaesthesiology and Intensive Care Medicine, Clinic for Surgery, Clinical Hospital Center Zagreb, Zagreb, Croatia
Address [1] 297341 0
Kispaticeva 12, 10000 Zagreb, Croatia
Country [1] 297341 0
Croatia
Primary sponsor type
Hospital
Name
Department for Anaesthesiology and Intensive Care Medicine, Clinic for Surgery, Clinical Hospital Center Zagreb, Zagreb, Croatia
Address
Kispaticeva 12, 10000 Zagreb, Croatia
Country
Croatia
Secondary sponsor category [1] 296318 0
None
Name [1] 296318 0
Address [1] 296318 0
Country [1] 296318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298441 0
Ethical Committe of the Obstetrics and Gynecology Clinic
Ethics committee address [1] 298441 0
Petrova 13
10000 Zagreb
Ethics committee country [1] 298441 0
Croatia
Date submitted for ethics approval [1] 298441 0
21/08/2017
Approval date [1] 298441 0
24/08/2017
Ethics approval number [1] 298441 0
021-1/121-17

Summary
Brief summary
Royal College of Anaesthetists (RCOG), in their Audit from 2012, suggests that an indicator of the quality of obstetric care, except the rate of general and regional anaesthesia, should be the rate of conversion of regional analgesia to general anaesthesia for caesarean section. That rate, depending on the urgency category of C-section, should not be larger than 1% for category 4 and 15% for category 1. The primary goal of this study is to compare types of anaesthesia used at our department with RCOG standards by retrospectively analysing the type of anaesthesia used for C-section during the three-year period. The secondary goal is to establish which factors led to failure of regional anaesthesia for C-section.
Trial website
Trial related presentations / publications
Public notes
Ethics approval was attained after recruitment of the first participant because at the time of the recruitment of the first participant, there was still no initiative to conduct this particular trial. However, the above mentioned Ethical Committe agreed to approve this research, because all of the recruited patients have read and signed the informed consent in which they agreed that all of the data in their medical records can be used for scientific purpose, whether in ongoing trials or in any future retrospective trials. In the informed consent (which was signed by all of the recruited patients) it was also stated that the personal data of each particular patient is secured.
Attachments [1] 1989 1989 0 0
http://www.anzctr.org.au/AnzctrAttachments/373511-consent form.docx (Participant information/consent)

Contacts
Principal investigator
Name 77102 0
Dr Slobodan Mihaljevic
Address 77102 0
Department of Anesthesiology, Reanimatology and Intensive care medicine
Clinical Center Zagreb
Kispaticeva 12
10 000 Zagreb
Country 77102 0
Croatia
Phone 77102 0
+385915024223
Fax 77102 0
Email 77102 0
smsmihaljevic@gmail.com
Contact person for public queries
Name 77103 0
Miss Lada Lijovic
Address 77103 0
Department of Anesthesiology of Obstetrics and Gynecology Clinic
Clinical Hospital Center Zagreb
Petrova 3
10 000 Zagreb
Country 77103 0
Croatia
Phone 77103 0
+385958950935
Fax 77103 0
Email 77103 0
lada.lijovic@gmail.com
Contact person for scientific queries
Name 77104 0
Miss Lada Lijovic
Address 77104 0
Department of Anesthesiology of Obstetrics and Gynecology Clinic
Clinical Hospital Center Zagreb
Petrova 3
10 000 Zagreb
Country 77104 0
Croatia
Phone 77104 0
+385958950935
Fax 77104 0
Email 77104 0
lada.lijovic@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary