Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000576426
Ethics application status
Approved
Date submitted
18/02/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of intrauterine packing versus balloon tamponade in controlling postpartum hemorrhage in patients diagnosed with postpartum hemorrhage
Scientific title
Effectiveness of intrauterine packing versus balloon tamponade in controlling postpartum hemorrhage in patients diagnosed with postpartum hemorrhage
Secondary ID [1] 314000 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum hemorrhage 336730 0
Condition category
Condition code
Reproductive Health and Childbirth 333228 333228 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two basic interventions (Intrauterine packing and balloon tamponade) will be applied for management of postpartum hemorrhage in this study. The balloon tamponade with 24 fr catheter will be applied by postgraduate resident for 6 to 8 hours in labor room. The deflated catheter will be inserted into the uterine cavity, inflated with 60 to 80 ml of sterile saline and the patient will be kept under direct observation for the said duration and will be considered successful if no bleed found
Intervention code [1] 330582 0
Treatment: Other
Comparator / control treatment
Intrauterine packing, which will be done with 1 to 3 abdominal packs by postgraduate resident for 6 to 8 hours in labor room and the patient will be kept under direct observation for the said duration, and will be considered successful if no bleed found.
Control group
Active

Outcomes
Primary outcome [1] 340799 0
Hemostasis
Timepoint [1] 340799 0
within 15 minutes of intervention completion
Secondary outcome [1] 445104 0
Hemostasis
Timepoint [1] 445104 0
6 to 8 hours of intervention completion

Eligibility
Key inclusion criteria
Women age 18 to 40 years
Singleton pregnancy on ultrasound
Gestational age > 36 weeks of last menstrual period (LMP)
Any parity
Postpartum hemorrhage as per operational definition
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Postpartum hemorrhage due to perineal, cervical or vaginal tear
Postpartum hemorrhage due to retained product of placenta
Vaginal delivery after one previous cesarean section,
History of coagulation disorder

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment outside Australia
Country [1] 26902 0
Pakistan
State/province [1] 26902 0

Funding & Sponsors
Funding source category [1] 318506 0
Self funded/Unfunded
Name [1] 318506 0
Country [1] 318506 0
Primary sponsor type
University
Name
College of Physicians and Surgeons, Pakistan
Address
Country
Pakistan
Secondary sponsor category [1] 320904 0
None
Name [1] 320904 0
Address [1] 320904 0
Country [1] 320904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317111 0
Institutional Review Board, Lady Reading Hospital, Medical Teaching Institute, Peshawar
Ethics committee address [1] 317111 0
Ethics committee country [1] 317111 0
Pakistan
Date submitted for ethics approval [1] 317111 0
01/07/2024
Approval date [1] 317111 0
25/07/2024
Ethics approval number [1] 317111 0

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

Contacts
Principal investigator
Name 140030 0
Dr Ayesha
Address 140030 0
Mohalla Boosa khel, post office Charsadda Town, tehsil & district Charsadda, Khyber Pakhtoonkhwa, Pakistan
Country 140030 0
Pakistan
Phone 140030 0
+923327828046
Fax 140030 0
Email 140030 0
[email protected]
Contact person for public queries
Name 140031 0
Ayesha
Address 140031 0
Mohalla Boosa khel, post office Charsadda Town, tehsil & district Charsadda, Khyber Pakhtoonkhwa, Pakistan
Country 140031 0
Pakistan
Phone 140031 0
+923327828046
Fax 140031 0
Email 140031 0
[email protected]
Contact person for scientific queries
Name 140032 0
Ayesha
Address 140032 0
Mohalla Boosa khel, post office Charsadda Town, tehsil & district Charsadda, Khyber Pakhtoonkhwa, Pakistan
Country 140032 0
Pakistan
Phone 140032 0
+923327828046
Fax 140032 0
Email 140032 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.