Trial Review

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
ACTRN12613001199707
Ethics application status
Approved
Date submitted
19/10/2013
Date registered
31/10/2013
Date last updated
31/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of blunt versus sharp expansion of uterine incision at caesarean delivery for perioperative hemorrhage
Scientific title
Comparison of blunt versus sharp expansion of uterine incision at caesarean delivery for perioperative hemorrhage: A randomised clinical trial
Secondary ID [1] 283418 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effect of caesarean section's surgical techniques on maternal blood loss 290331 0
Condition category
Condition code
Surgery 290732 290732 0 0
Surgical techniques
Reproductive Health and Childbirth 290803 290803 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
During caeserean delivery, after applying low transverse segment incision, as a surgical option the incision is expansed either bluntly with finger laterally or sharply with scissors laterally. The intraoperatively maternal blood loss and unintended extensions of insicion is determined.
Intervention code [1] 288142 0
Treatment: Surgery
Comparator / control treatment
the comparator including the patients of whom had caeserean delivery with the srgical technique of sharply expansion of uterine incision.
Control group
Active

Outcomes
Primary outcome [1] 290731 0
maternal blood loss that will be determined by calculation the difference in the postoperative and preoperative weight of surgical drapes and towels.Also, the difference between the initial hematocrit and the final hematocrit (24 h after the operation) was evaluated.
Timepoint [1] 290731 0
intraoperatively and also postoperative 24 hour.
Secondary outcome [1] 305107 0
unintended extension of incision evaluated as any defect beyond original incision.
Timepoint [1] 305107 0
intraoperatively
Secondary outcome [2] 305108 0
postpartum endometritis diagnosed as the presence of postoperative fever (>38 degrees celcius on two occasions and 6 h apart after the first postoperative day) and as at least two of the following symptoms: uterine tenderness, foul smelling lochia and leukocytosis (white cell count >15,000/ml).
Timepoint [2] 305108 0
first postoperative day
Secondary outcome [3] 305109 0
need for transfusion diagnosed as hemodynamic instability and with the hematocrit level under the 25.
Timepoint [3] 305109 0
24 hour postoperatively

Eligibility
Key inclusion criteria
the women who had elective caeserean delivery for obstetric reasons.
Minimum age
25 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
women who declined to participate, women undergoing emergency surgery with insufficient time to properly counsel the patient, and women in whom either a low segment vertical uterine or a classical upper segment were utilised and patients with known coagulopathy and multiple gestations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the allocation was done with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment to one of the two treatment groups was generated using a table of random numbers. The assigned treatment was written on a card and sealed in secure opaque envelopes numbered in sequence.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size and power calculation was undertaken,
and it was determined that 425 women in each group was
sufficient power (power of 0.80, a of 0.05, and b 1/4 0.20)
to demonstrate a difference of 5% between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2010
Actual
19/05/2010
Date of last participant enrolment
Anticipated
Actual
7/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
425
Accrual to date
Final
Recruitment outside Australia
Country [1] 5526 0
Turkey
State/province [1] 5526 0
istanbul
Country [2] 5527 0
Turkey
State/province [2] 5527 0
van

Funding & Sponsors
Funding source category [1] 288145 0
Self funded/Unfunded
Name [1] 288145 0
erbil karaman
Country [1] 288145 0
Turkey
Primary sponsor type
Individual
Name
erbil karaman
Address
ercis state hospital department of obstetric
toki evleri tekevler sokak k7-3 daire 14 ercis van
Country
Turkey
Secondary sponsor category [1] 286862 0
None
Name [1] 286862 0
none
Address [1] 286862 0
none
Country [1] 286862 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To determine the effect of 2 methods of expansion of the uterine incision during caesarean delivery on maternal blood loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43738 0
Dr erbil karaman
Address 43738 0
turkish gynecology and obstetric associationtoki evleri tekevler sokak k7-3 daire 14 ercis, van
Country 43738 0
Turkey
Phone 43738 0
+905555080712
Fax 43738 0
Email 43738 0
[email protected]
Contact person for public queries
Name 43739 0
Dr erbil karaman
Address 43739 0
turkish gynecology and obstetric association,
toki evleri tekevler sokak k7-3 daire 14 ercis, van
Country 43739 0
Turkey
Phone 43739 0
+95555080712
Fax 43739 0
Email 43739 0
[email protected]
Contact person for scientific queries
Name 43740 0
Dr erbil karaman
Address 43740 0
turkish gynecology and obstetric association,
toki evleri tekevler sokak k7-3 daire 14 ercis, van
Country 43740 0
Turkey
Phone 43740 0
+905555080712
Fax 43740 0
Email 43740 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.