To compare the efficacy of balloon tamponade versus Sengstaken-Blakemore tube in patients with primary PPH.
Design
Open label, randomized controlled trial.
Settings and conduct
Gynecology and Obstetrics Department, Bahawal Victoria Hospital, Bahawalpur, Pakistan
Participants/Inclusion and exclusion criteria
The inclusion criteria were females aged between 18-40 years of parity 1-6, gravida 1-6, gestational age 31 to 41 weeks, with primary PPH. The exclusion criteria were critically ill patients, those with documented end-organ liver or renal failure (assessed by a medical record), or those with a documented bleeding disorder history, i.e., factor deficiencies (assessed by a medical record). Those with secondary PPH, PPH due to trauma or retained products of the placenta, or those with chorioamnitis were also excluded.
Intervention groups
In Balloon tamponade group, females underwent balloon tamponade, and those in Sengstaken-Blakemore group underwent Sengstaken-Blakemore tube insertion and balloon removal after 24 hours.
Main outcome variables
Effectiveness will be labeled as failed if there was more than 100 ml of blood loss within 10 minutes after the removal of the balloon tamponade or Sengstaken-Blakemore tube
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221231056999N3
Registration date:2024-05-10, 1403/02/21
Registration timing:prospective
Last update:2024-05-10, 1403/02/21
Update count:0
Registration date
2024-05-10, 1403/02/21
Registrant information
Name
M Aamir
Name of organization / entity
RESnTEC, Institute of Research
Country
Pakistan
Phone
+92 321 6801143
Email address
aamir@resntec.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-01, 1403/03/12
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Balloon Tamponade with a Condom Catheter versus Using a Sengstaken-Blakemore Tube in Patients with Primary Postpartum Hemorrhage
Public title
Effectiveness of Balloon Tamponade with a Condom Catheter versus Using a Sengstaken-Blakemore Tube in Patients with Primary Postpartum Hemorrhage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females aged between 18-40 years
Parity 1-6
Gravida 1-6
Gestational age 31 to 41 weeks
Primary postpartum hemorrhage (PPH)
Exclusion criteria:
Critically ill patients
Documented end-organ liver or renal failure (assessed by a medical record)
Documented bleeding disorder history, i.e., factor deficiencies (assessed by a medical record).
Secondary PPH
Retained products of the placenta
Chorioamnitis
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Females were divided into two equal groups by a simple lottery method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethical Review Board
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Postal code
63100
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
2363/DME/QAMC
Health conditions studied
1
Description of health condition studied
Primary postpartum hemorrhage
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effectiveness will be labeled as yes, where there was no blood loss for 24 hours after the removal of the pack or Foleys. Effectiveness will be labeled as failed if there was more than 100 ml of blood loss within 10 minutes after the removal of the balloon tamponade or Sengstaken-Blakemore tube.
Timepoint
24 hours
Method of measurement
Visual evidence of blood loss as per outcome measures.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Balloon tamponade group
Category
Treatment - Surgery
2
Description
Intervention group: Sengstaken-Blakemore group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Obstetrics Department, Bahawal Victoria Hospital
Full name of responsible person
Dr. Shamas un Nisa
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 301 7706383
Email
drshamaamin73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bahawal Victoria Hospital
Full name of responsible person
Dr. Shamas un Nisa
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Postal code
63100
Phone
+92 301 7706383
Email
drshamaamin73@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bahawal Victoria Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bahawal Victoria Hospital
Full name of responsible person
Dr. Shamas un Nisa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 301 7706383
Email
drshamaamin73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bahawal Victoria Hospital
Full name of responsible person
Dr. Shamas un Nisa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 301 7706383
Email
drshamaamin73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bahawal Victoria Hospital
Full name of responsible person
Dr. Shamas un Nisa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Circular Road, Bahawalpur
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 301 7706383
Email
drshamaamin73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We are undecided about data sharing right now.
When the data will become available and for how long
We are undecided about data sharing right now.
To whom data/document is available
We are undecided about data sharing right now.
Under which criteria data/document could be used
We are undecided about data sharing right now.
From where data/document is obtainable
We are undecided about data sharing right now.
What processes are involved for a request to access data/document