Postpartum Hemorrhage, Uterine Atony
Conditions
Keywords
postpartum hemorrhage, uterine atony, balloon tamponade, uterine packing
Brief summary
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
PROCEDUREUterine 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.
PROCEDUREUterine 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.
Sponsors
Khyber Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention | 24 hours after 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. |
Contacts
CONTACTMadiha Yar Khan
Outcome results
None listed