Postpartum Hemorrhage
Conditions
Keywords
postpartum hemorrhage
Brief summary
This multicenter study aims to evaluate effectiveness and safety of using the AAJT-S device as a temporary intervention for severe, atony-related PPH that is refractory to standard therapies
Detailed description
This is a multicenter, prospective, single-arm treatment study aimed at evaluating the feasibility, safety, and clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) as a temporary intervention for managing severe postpartum hemorrhage (PPH) caused by uterine atony unresponsive to standard first-line treatments. The study will be conducted across several sites in Ukraine, in regions affected by armed conflict, where access to surgical care and blood products may be delayed. Eligible participants are postpartum women aged 18 or older who experience primary PPH with estimated blood loss greater than 1000 mL and who do not respond to uterotonics or balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded. When standard interventions fail and eligibility is confirmed, the AAJT-S device will be applied to the upper abdomen and inflated to 250 mmHg to temporarily occlude the abdominal aorta and inferior vena cava. This intervention aims to reduce pelvic blood flow and control bleeding, buying critical time to assemble the surgical team, initiate blood transfusion, and establish anesthesia.
Interventions
The AAJT-S is a non-invasive, externally applied medical device designed to achieve temporary occlusion of the abdominal aorta and inferior vena cava by inflating a pneumatic bladder to 250 mmHg. In this study, the device will be used as a temporizing measure for patients with severe postpartum hemorrhage unresponsive to standard uterotonics and balloon tamponade. The device will be applied horizontally over the upper abdomen and inflated using a built-in pressure gauge. The intended effect is to reduce pelvic blood flow and allow time for mobilization of surgical resources and blood transfusion. Maximum application time will not exceed 60 minutes, in accordance with established safety guidelines.
Sponsors
LLC UkrMedGroup
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, single-arm, interventional treatment study designed to assess the effectiveness and safety of the AAJT-S device in the management of severe postpartum hemorrhage. All eligible participants will receive the same intervention without randomization or control group. Data will be collected in real time across multiple centers, and the study does not include blinding.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Clinical diagnosis of postpartum hemorrhage (PPH) refractory to uterotonics and intrauterine balloon tamponade * Estimated blood loss greater than 1300 mL * Oral informed consent provided prior to device application
Exclusion criteria
* Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: The proportion of cases achieving rapid hemorrhage control after AAJT-S application. | Within 5 minutes of AAJT-S device application | Visible cessation of external vaginal bleeding (no ongoing blood flow from the cervix or vaginal canal observed by the clinical team) within 5 minutes of device inflation. The attending obstetrician will visually assess bleeding immediately after inflation and every 30 seconds until 5 minutes. Control will be recorded at the first time point when no active bleeding is observed (slight spotting is not considered ongoing hemorrhage). If bleeding persists beyond 5 minutes, the case is classified as failure of primary endpoint, even if subsequent control is achieved. |
| Safety: Incidence (i.e., Rate or Number of Participants), Severity and Seriousness of Device-related Adverse Events from placement until 6-week postpartum follow-up | From device application until 6-week postpartum follow-up | Any untoward medical occurrence temporally associated with the AAJT-S device, regardless of causality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visually estimated blood loss (EBL) | From delivery until AAJT-S placement | Visually estimated blood loss (EBL) from delivery until AAJT-S placement (mL). |
Countries
Ukraine
Contacts
Primary ContactYevheniia Poliakova, Ph.D
Backup ContactViktor Oshovskyy, DMSc, PhD
Outcome results
None listed