Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Uterine Balloon Tamponade, Uterine gauze packing.
- Who it may be relevant to
- Registry conditions: Postpartum Hemorrhage, Uterine Atony. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Efficacy of Uterine Balloon Tamponade Versus Uterine Gauze Packing in Patients With Postpartum Hemorrhage With Uterine Atony
Overview
Postpartum hemorrhage due to uterine atony is a major cause of maternal morbidity and mortality. This randomized controlled trial aims to compare the efficacy of uterine balloon tamponade and uterine gauze packing in controlling bleeding in women with postpartum hemorrhage. A total of 216 participants will be randomly assigned to one of the two treatment groups. All patients will receive standard medical management including uterotonic agents prior to intervention. The primary outcome is cessation of uterine bleeding within 24 hours after the procedure. This study aims to identify a safe and effective method for managing postpartum hemorrhage in a resource-limited setting.
Interventions
- Procedure Uterine Balloon Tamponade
Uterine balloon tamponade will be performed using sterile Foley catheters inserted into the uterine cavity and inflated with normal saline to achieve hemostasis in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques. - Procedure Uterine gauze packing
Uterine gauze packing will be performed using sterile gauze placed within the uterine cavity and vagina to apply pressure and control bleeding in patients with postpartum hemorrhage due to uterine atony, following standard aseptic techniques.
Primary outcome measures
- Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention [Time frame: 24 hours after intervention]
Eligibility criteria
Inclusion criteria
- Women aged 18 to 40 years
- Gestational age between 37 and 42 weeks
- Parity up to 4
- Diagnosed with postpartum hemorrhage due to uterine atony
Exclusion criteria
- Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
- Retained products of conception
- Vaginal delivery after previous cesarean section
- Known coagulation disorders
- Sepsis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07609589 · 885/DME/KMC