Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKhyber Teaching Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
Retained products of conception
Vaginal delivery after previous cesarean section
Known coagulation disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Uterine Balloon Tamponade
Procedure/SurgeryUterine 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.
Uterine gauze packing
Procedure/SurgeryUterine 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.
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Uterine Balloon TamponadeExperimental treatment 1 intervention
Group B: Uterine Gauze PackingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24 hours after interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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