Intrauterine Balloon (Bakri©) Versus Uterine Tamponade With Chitosan Gauze (Celox PPH©) in the Management of Postpartum Hemorrhage Refractory to Medical Treatmen

NCT06996808 | Not Yet Recruiting

• 1 other identifier: 400/8.04.2025 4a4
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin levels

  Materal hemoglobin levels will be assessd at diagnosis of Post partum hemorrage, 24 after delievry and at the discharge

  From enrollment to 24 hours after delivery

• Needs of blood transfusion

  From enrollment to 24 hours after delivery

Secondary Outcomes (4)

• Hysterectomy

  From enrollment to one week after delivery

• Lenght of hospital stay

  From delivery up to 6 weeks postpartum

• ICU admission

  From enrollment up to 6 weeks postpartum

• Need for surgical intervention

  From enrollment to the firstday after delivery and at one week

Study Arms (2)

: Bakri Balloon

ACTIVE COMPARATOR

Bakri Balloon Standard insertion and inflation as per hospital protocol following delivery.

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.

Device: Celox gauze

Interventions

Bakri Baloon DEVICE

Bakri Balloon Standard insertion and inflation as per hospital protocol following delivery.

: Bakri Balloon

Celox gauze DEVICE

Celox gauze will be placed intrauterine according to manufacturer instructions, post-vaginal or cesarean delivery. Duration and removal will follow standardized clinical guidelines

: Celox Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Giuseppe RIZZO, Professor

CONTACT

+393386973001; giuseppe.rizzo@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-05