Postpartum HemorrhageNCT06996808
Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen
A study testing Bakri Baloon and Celox gauze in people with Postpartum Hemorrhage, run by University of Roma La Sapienza.
Trial summary
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Bakri Baloon and Celox gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to Jan 2029
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for inclusion:
- Women aged 18 years or older who have delivered either vaginally or via cesarean section.
- Diagnosis of postpartum hemorrhage, defined as an estimated blood loss (EBL) greater than 1000 mL within the first 24 hours postpartum.
- Refractory to first-line medical therapy, specifically high-dose oxytocin (≥40 IU total administered intravenously or intramuscularly), a full dose of methylergometrine (0.2 mg IM or IV), and administration of tranexamic acid (1 g IV).
- Hemodynamically stable at the time of enrollment, allowing time for the application of a mechanical or topical intervention.
Exclusion Criteria: Patients will be excluded if they meet any of the following conditions:
- Clinical or radiological suspicion of placenta accreta spectrum (PAS), including placenta increta or percreta, which may necessitate immediate surgical management.
- Known pre-existing or newly diagnosed coagulopathy, including but not limited to thrombocytopenia (<50,000/μL), von Willebrand disease, hemophilia, or disseminated intravascular coagulation (DIC), which may compromise the safety or efficacy of the interventions.
- Hemodynamic instability defined by persistent hypotension (systolic BP <90 mmHg or MAP <65 mmHg) despite resuscitation, or active decision to proceed to surgical intervention (e.g., laparotomy, uterine artery embolization, or hysterectomy) without delay.
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: Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatment: A Multicenter Randomized Controlled Trial
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when blood loss exceeds 1000 mL regardless of delivery mode. The initial management of PPH includes the administration of uterotonics such as oxytocin, methylergometrine, and tranexamic acid. However, a subset of patients remains unresponsive to medical therapy, necessitating second-line interventions to avoid escalation to invasive procedures such as uterine artery embolization or peripartum hysterectomy.
An intrauterine balloon tamponade device (Bakri©), is commonly used as a mechanical method to control uterine bleeding by exerting direct pressure on the uterine walls. Its use has been widely adopted and incorporated into international guidelines due to its relative ease of use and safety profile. Despite its effectiveness, the failure rate of Bakri balloon placement can range from 20% to 40%, especially in cases of coagulopathy or diffuse atony.
Read more
Gauzes with a chitosan-based hemostatic dressing (Celox PPH ©) , has been extensively used in trauma settings and is increasingly being explored for surgical and obstetric applications. Its mechanism involves promoting clot formation independent of the clotting cascade, making it potentially beneficial in patients with coagulopathies. Preliminary data and case reports suggest that Celox PPH© may be effective in controlling intrauterine bleeding when used as a packing material after vaginal or cesarean delivery, but no high-quality randomized controlled trial has yet compared it directly with standard interventions.
Given the clinical need for alternative second-line treatments for PPH unresponsive to medical therapy, this study proposes a head-to-head comparison of the Bakri balloon and Celox gauze. The findings will help inform evidence-based guidelines and may offer new strategies to reduce maternal transfusion requirements, prevent hysterectomy, and shorten hospital stays in patients experiencing severe PPH.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Bakri Baloon, Celox gauze
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bakri BaloonDevice
Bakri Balloon Standard insertion and inflation as per hospital protocol following delivery.
Celox gauzeDevice
Celox gauze will be placed intrauterine according to manufacturer instructions, post-vaginal or cesarean delivery. Duration and removal will follow standardized clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| : Bakri Balloon | Active comparator | Bakri Balloon Standard insertion and inflation as per hospital protocol following delivery. Receives: Device: Bakri Baloon |
| : Celox Gauze | Experimental | Celox gauze will be placed intrauterine according to manufacturer instructions, post-vaginal or cesarean delivery. Duration and removal will follow standardized clinical guidelines. Receives: Device: Celox gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin levels
Materal hemoglobin levels will be assessd at diagnosis of Post partum hemorrage, 24 after delievry and at the discharge
Measured: From enrollment to 24 hours after delivery
Needs of blood transfusion
Measured: From enrollment to 24 hours after delivery
Secondary outcomes (4)
Hysterectomy
Need of performing hysterectomy
Measured: From enrollment to one week after delivery
Lenght of hospital stay
Measured: From delivery up to 6 weeks postpartum
ICU admission
Measured: From enrollment up to 6 weeks postpartum
Need for surgical intervention
needs of other surgical procedures (i.e, suture of uterine lacerations, uterine hemostatic suture(ì)
Measured: From enrollment to the firstday after delivery and at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completionJan 2029 (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.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Rizzo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996808
- Sponsor's protocol ID
- 400/8.04.2025 4a4
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatment: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06996808
- Acronym / sponsor ID
- 400/8.04.2025 4a4
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 May 2025 (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 (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when blood loss exceeds 1000 mL regardless of delivery mode. The initial management of PPH includes the administration of uterotonics such as oxytocin, methylergometrine, and tranexamic acid. However, a subset of patients remains unresponsive to medical therapy, necessitating second-line interventions to avoid escalation to invasive procedures such as uterine artery embolization or peripartum hysterectomy.
An intrauterine balloon tamponade device (Bakri©), is commonly used as a mechanical method to control uterine bleeding by exerting direct pressure on the uterine walls. Its use has been widely adopted and incorporated into international guidelines due to its relative ease of use and safety profile. Despite its effectiveness, the failure rate of Bakri balloon placement can range from 20% to 40%, especially in cases of coagulopathy or diffuse atony.
Gauzes with a chitosan-based hemostatic dressing (Celox PPH ©) , has been extensively used in trauma settings and is increasingly being explored for surgical and obstetric applications. Its mechanism involves promoting clot formation independent of the clotting cascade, making it potentially beneficial in patients with coagulopathies. Preliminary data and case reports suggest that Celox PPH© may be effective in controlling intrauterine bleeding when used as a packing material after vaginal or cesarean delivery, but no high-quality randomized controlled trial has yet compared it directly with standard interventions.
Given the clinical need for alternative second-line treatments for PPH unresponsive to medical therapy, this study proposes a head-to-head comparison of the Bakri balloon and Celox gauze. The findings will help inform evidence-based guidelines and may offer new strategies to reduce maternal transfusion requirements, prevent hysterectomy, and shorten hospital stays in patients experiencing severe PPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| : Bakri Balloon | Active comparator | Device: Bakri BaloonBakri Balloon Standard insertion and inflation as per hospital protocol following delivery. |
| : Celox Gauze | Experimental | Device: Celox gauzeCelox gauze will be placed intrauterine according to manufacturer instructions, post-vaginal or cesarean delivery. Duration and removal will follow standardized clinical guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Bakri BaloonBakri Balloon Standard insertion and inflation as per hospital protocol following delivery. | Device | : Bakri Balloon |
| Celox gauzeCelox gauze will be placed intrauterine according to manufacturer instructions, post-vaginal or cesarean delivery. Duration and removal will follow standardized clinical guidelines | Device | : Celox Gauze |
Primary outcome
Change in Hemoglobin levels
Time frame: From enrollment to 24 hours after delivery
Materal hemoglobin levels will be assessd at diagnosis of Post partum hemorrage, 24 after delievry and at the discharge
Needs of blood transfusion
Time frame: From enrollment to 24 hours after delivery
4 secondary outcomes
Hysterectomy
Time frame: From enrollment to one week after delivery
Lenght of hospital stay
Time frame: From delivery up to 6 weeks postpartum
ICU admission
Time frame: From enrollment up to 6 weeks postpartum
Need for surgical intervention
Time frame: From enrollment to the firstday after delivery and at one week
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 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 Bakri Baloon and Celox gauze in people with Postpartum Hemorrhage, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Jun 2025. 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 Giuseppe RIZZO, Professor (+393386973001, giuseppe.rizzo@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin levels (time frame: From enrollment to 24 hours after delivery). The study lists 2 primary outcomes in all. 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 4 Jun 2025.