Postpartum HemorrhageNCT07609589
Balloon Tamponade Versus Gauze Packing for Postpartum Hemorrhage
A study testing Uterine Balloon Tamponade and Uterine gauze packing in people with Postpartum Hemorrhage and Uterine Atony, run by Khyber Teaching Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony
- What is being tested?
- Uterine Balloon Tamponade and Uterine gauze packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
- Retained products of conception
- Vaginal delivery after previous cesarean section
- Known coagulation disorders
- Sepsis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Efficacy of Uterine Balloon Tamponade Versus Uterine Gauze Packing in Patients With Postpartum Hemorrhage With Uterine Atony
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.
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Being tested
- Uterine Balloon Tamponade, Uterine gauze packing
- Keywords
- postpartum hemorrhage, uterine atony, balloon tamponade, uterine packing
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Balloon TamponadeProcedure or surgery
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.
Uterine gauze packingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Uterine Balloon Tamponade | Experimental | Not described Receives: Procedure: Uterine Balloon Tamponade |
| Uterine Gauze Packing | Active comparator | Not described Receives: Procedure: Uterine gauze packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madiha Yar Khan, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609589
- Sponsor's protocol ID
- 885/DME/KMC
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Uterine Balloon Tamponade Versus Uterine Gauze Packing in Patients With Postpartum Hemorrhage With Uterine Atony
- ClinicalTrials.gov ID
- NCT07609589
- Acronym / sponsor ID
- 885/DME/KMC
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Keywords
- postpartum hemorrhage, uterine atony, balloon tamponade, uterine packing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine Balloon Tamponade | Experimental | Procedure: Uterine Balloon Tamponade |
| Uterine Gauze Packing | Active comparator | Procedure: Uterine gauze packing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Postpartum hemorrhage due to perineal, cervical, or vaginal trauma
- Retained products of conception
- Vaginal delivery after previous cesarean section
- Known coagulation disorders
- Sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine Balloon TamponadeUterine 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 or surgery | Uterine Balloon Tamponade |
| Uterine gauze packingUterine 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. | Procedure or surgery | Uterine Gauze Packing |
Primary outcome
Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Balloon Tamponade and Uterine gauze packing in people with Postpartum Hemorrhage and Uterine Atony, run by Khyber Teaching Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madiha Yar Khan (+923486106764, madihak067@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Control of Postpartum Hemorrhage Assessed by Cessation of Active Uterine Bleeding Without Need for Additional Surgical Intervention (time frame: 24 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.