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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uterine Balloon Tamponade | Experimental |
| |
| Uterine Gauze Packing | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine Balloon Tamponade | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention | Successful control of postpartum hemorrhage will be defined as cessation of active uterine bleeding within 24 hours after uterine balloon tamponade or uterine gauze packing, without the need for additional surgical procedures (e.g., hysterectomy, arterial ligation, or repeat tamponade/packing), as assessed clinically by the treating obstetric team. | 24 hours after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madiha Yar Khan | Contact | +923486106764 | madihak067@gmail.com |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D014593 | Uterine Inertia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D058738 | Uterine Balloon Tamponade |
| ID | Term |
|---|---|
| D021721 | Balloon Occlusion |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D058450 | Endotamponade |
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| Uterine gauze packing | Procedure | 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. |
|
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004420 | Dystocia |
| D006489 |
| Hemostatic Techniques |
| D004621 | Embolization, Therapeutic |
| D060205 | Therapeutic Occlusion |
| D008919 | Investigative Techniques |