Postpartum Haemorrhage (PPH)
Conditions
Keywords
uterine atony, postpartum haemorrhage, Emergency Obstetric Care, Aortic Compression
Brief summary
The purpose of this study is to evaluate whether a medical device called the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) can safely and effectively temporarily stop severe bleeding after childbirth (known as postpartum hemorrhage) when standard treatments fail. The main question the study aims to answer is: Can the AAJT-S device temporarily control life-threatening postpartum bleeding long enough to allow doctors to prepare for surgery and other definitive treatment?
Detailed description
This prospective, open-label, non-randomized, proof-of-concept study will assess the feasibility, safety, and preliminary clinical effectiveness of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device as a temporizing measure for severe postpartum hemorrhage (PPH) due to uterine atony that is unresponsive to standard first-line therapies. The study will be conducted in a tertiary referral center in Zaporizhzhia, Ukraine, located in a conflict-affected region with limited access to timely surgical intervention and blood products. Eligible participants will be adult postpartum patients (≥18 years) who develop primary PPH with blood loss exceeding 1,000 mL and who fail to respond to pharmacologic uterotonics and balloon tamponade. Patients with hemorrhage due to trauma, coagulopathy, or retained placental tissue will be excluded. Once standard management protocols are exhausted and eligibility is confirmed, the AAJT-S device will be deployed over the upper abdomen and inflated to 250 mmHg to achieve temporary occlusion of the abdominal aorta and inferior vena cava. The device is intended to reduce pelvic blood flow and thereby control hemorrhage during the critical window required to mobilize a surgical team, arrange blood transfusion, and secure anesthesia. The device will remain in place for a maximum of 60 minutes, consistent with published safety guidelines. Clinical endpoints will include time to bleeding control, hemodynamic stabilization, need for additional surgical intervention, and total blood loss. Safety endpoints will include thrombotic events, ischemic injury, infections, and any other adverse events related to device use. Data will be collected prospectively, including demographic characteristics, obstetric history, timing and duration of interventions, and perioperative outcomes. Descriptive statistics will be used to summarize findings, with no formal hypothesis testing due to the pilot nature of the study. All participants will receive routine inpatient follow-up, and longer-term outcomes will be assessed via scheduled in-person visits and structured telephone interviews at 6 and 12 months postpartum to evaluate for delayed complications and maternal recovery. The study is designed to generate preliminary data for further exploration of the AAJT-S device as a potential emergency tool for PPH management in resource-limited and crisis settings.
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, open-label proof-of-concept study. All eligible participants will receive the investigational intervention (AAJT-S device) as an adjunct to standard care for severe postpartum hemorrhage unresponsive to uterotonics and balloon tamponade. No comparator or control group is included. The study is designed to evaluate feasibility, safety, and preliminary clinical outcomes in a conflict-affected, resource-limited setting.
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 1,000 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 |
|---|---|---|
| Time to Bleeding Control After AAJT-S Device Application | Within 10 minutes of AAJT-S device application | Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion. |
| Total Measured Blood Loss (Pre- and Post-intervention) | From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours) | Sum of blood loss (in mL), measured by pad/towel weights after AAJT-S use until definitive hemostasis. |
| Incidence of Device-related Complications | From device application through hospital discharge (up to 7 days) | Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic Stabilization Time | First 60 minutes after AAJT-S application | Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse \<110 bpm. |
| Long-term Maternal Recovery Status | At 6 weeks postpartum | Assessed via follow-up calls and scheduled ultrasound visits at 6 weeks postpartum, including return to normal activity, presence of chronic pain, or menstrual abnormalities. |
Countries
Ukraine
Participant flow
Recruitment details
Participants were recruited at Olexandrivska Hospital (Zaporizhzhia, Ukraine) between December 2024 and April 2025. Recruitment was based on clinical diagnosis of refractory postpartum hemorrhage due to uterine atony, and all participants provided oral informed consent.
Pre-assignment details
All enrolled participants (N=4) met the eligibility criteria and were assigned to the intervention arm. No screening failures, exclusions, or withdrawals occurred prior to device application.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: AAJT-S Device Intervention Arm Participants in this arm received standard postpartum hemorrhage (PPH) management followed by application of the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device if bleeding remains uncontrolled after uterotonics and uterine balloon tamponade. The device was applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention was intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | Experimental: AAJT-S Device Intervention Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Estimated Blood Loss Prior to AAJT-S Application | 1125 ml | — |
| Parity | 2.5 Births STANDARD_DEVIATION 1.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Ukraine | 4 Participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Incidence of Device-related Complications
Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use.
Time frame: From device application through hospital discharge (up to 7 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AAJT-S Device Intervention Arm | Incidence of Device-related Complications | 0 Participants |
Primary
Time to Bleeding Control After AAJT-S Device Application
Defined as the time (in minutes) from inflation of the AAJT-S device to visible cessation of external vaginal bleeding in patients with severe postpartum hemorrhage due to uterine atony. Bleeding control will be determined by visual clinical assessment by the attending provider. This measure evaluates the immediate effectiveness of the intervention in stopping hemorrhage and buying time for definitive surgical management or transfusion.
Time frame: Within 10 minutes of AAJT-S device application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AAJT-S Device Intervention Arm | Time to Bleeding Control After AAJT-S Device Application | 2 Minutes | Standard Deviation 0.01 |
Primary
Total Measured Blood Loss (Pre- and Post-intervention)
Sum of blood loss (in mL), measured by pad/towel weights after AAJT-S use until definitive hemostasis.
Time frame: From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AAJT-S Device Intervention Arm | Total Measured Blood Loss (Pre- and Post-intervention) | 1425 ml |
Secondary
Hemodynamic Stabilization Time
Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse \<110 bpm.
Time frame: First 60 minutes after AAJT-S application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AAJT-S Device Intervention Arm | Hemodynamic Stabilization Time | 31.25 Minutes | Standard Deviation 6.29 |
Secondary
Long-term Maternal Recovery Status
Assessed via follow-up calls and scheduled ultrasound visits at 6 weeks postpartum, including return to normal activity, presence of chronic pain, or menstrual abnormalities.
Time frame: At 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AAJT-S Device Intervention Arm | Long-term Maternal Recovery Status | 4 Participants |