Postpartum Haemorrhage (PPH)TAOATNCT07016568
Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
A study testing Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) in people with Postpartum Haemorrhage (PPH), run by LLC UkrMedGroup at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Haemorrhage (PPH)
- What is being tested?
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Postpartum Haemorrhage (PPH)
- Being tested
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Keywords
- uterine atony, postpartum haemorrhage, Emergency Obstetric Care, Aortic Compression
- 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.
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| AAJT-S Device Intervention Arm | Experimental | Participants in this arm will receive 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 will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged. Receives: Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 minutes of AAJT-S device application
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.
Measured: From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)
Incidence of Device-related Complications
Includes thrombotic events, ischemic injury, skin necrosis, or technical malfunction during/after AAJT-S use.
Measured: From device application through hospital discharge (up to 7 days)
Secondary outcomes (2)
Hemodynamic Stabilization Time
Time from device inflation to achievement of target blood pressure (SBP ≥90 mmHg) and pulse <110 bpm.
Measured: First 60 minutes after AAJT-S application
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.
Measured: At 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Dec 2024
- Primary completion15 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum Haemorrhage (PPH)Studies 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
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- LLC UkrMedGroup
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viktor Oshovskyy, DMSc, PhD, MD, Principal investigator, pirhospr@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016568
- Sponsor's protocol ID
- 2024/EC/128094
- Acronym
- TAOAT
- Status last verified
- Oct 2025
- First submitted
- 4 Jun 2025
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of the clinical context, including emergency obstetric care in a war-affected setting. Additional ethical and regulatory considerations related to patient privacy and consent limit the possibility of external data sharing.
Publications
Soltan MH, Sadek RR. Experience managing postpartum hemorrhage at Minia University Maternity Hospital, Egypt: no mortality using external aortic compression. J Obstet Gynaecol Res. 2011 Nov;37(11):1557-63. doi: 10.1111/j.1447-0756.2011.01574.x. Epub 2011 Jun 16.
PubMed 21676082Soltan MH, Faragallah MF, Mosabah MH, Al-Adawy AR. External aortic compression device: the first aid for postpartum hemorrhage control. J Obstet Gynaecol Res. 2009 Jun;35(3):453-8. doi: 10.1111/j.1447-0756.2008.00975.x.
PubMed 19527382Kheirabadi BS, Dubick MA. Safe duration of Abdominal Aortic and Junctional Tourniquet application. J Trauma Acute Care Surg. 2019 Sep;87(3):740-741. doi: 10.1097/TA.0000000000002231. No abstract available.
PubMed 30768561Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda RA, Basanta N, Cininta N, Rivera-Torres LF, Bautista E, Hussein AM. External aortic compression: buying time to save lives in obstetric hemorrhage. Am J Obstet Gynecol. 2025 Feb;232(2):239-241. doi: 10.1016/j.ajog.2024.09.017. Epub 2024 Sep 18. No abstract available.
PubMed 39304012Riley DP, Burgess RW. External abdominal aortic compression: a study of a resuscitation manoeuvre for postpartum haemorrhage. Anaesth Intensive Care. 1994 Oct;22(5):571-5. doi: 10.1177/0310057X9402200512.
PubMed 7818062Nieto-Calvache AJ, Palacios Jaraquemada JM, Basanta N, Aryananda RA, Sinisterra-Diaz SE, Rodriguez F, Hidalgo Cardona A, Messa Bryon A. Internal manual compression of the aorta-an effective way to temporarily control pelvic bleeding in obstetrical hemorrhage. Am J Obstet Gynecol. 2022 Jul;227(1):96-97. doi: 10.1016/j.ajog.2022.02.040. Epub 2022 Mar 4.
PubMed 35248574Khan M, Jeyanathan J, Smith JE. Novel use for the abdominal tourniquet in the management of postpartum haemorrhage. J R Army Med Corps. 2018 Nov;164(6):463. doi: 10.1136/jramc-2018-000953. Epub 2018 Apr 6. No abstract available.
PubMed 29626141
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region
- ClinicalTrials.gov ID
- NCT07016568
- Acronym / sponsor ID
- TAOAT / 2024/EC/128094
- Conditions
- Postpartum Haemorrhage (PPH)
- Keywords
- uterine atony, postpartum haemorrhage, Emergency Obstetric Care, Aortic Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- LLC UkrMedGroupIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| AAJT-S Device Intervention Arm | Experimental | Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Participants in this arm will receive 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 will be applied to the upper abdomen and inflated to 250 mmHg to achieve temporary aortic occlusion for up to 60 minutes. The intervention is intended to temporize bleeding while definitive surgical treatment and blood transfusion are arranged. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded
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 |
|---|---|---|
| Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)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. | Device | AAJT-S Device Intervention Arm |
Primary outcome
Time to Bleeding Control After AAJT-S Device Application
Time frame: 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)
Time frame: 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
Time frame: 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.
2 secondary outcomes
Hemodynamic Stabilization Time
Time frame: First 60 minutes after AAJT-S application
Long-term Maternal Recovery Status
Time frame: At 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21676082Soltan MH, Sadek RR. Experience managing postpartum hemorrhage at Minia University Maternity Hospital, Egypt: no mortality using external aortic compression. J Obstet Gynaecol Res. 2011 Nov;37(11):1557-63. doi: 10.1111/j.1447-0756.2011.01574.x. Epub 2011 Jun 16.
- Background: PubMed 19527382Soltan MH, Faragallah MF, Mosabah MH, Al-Adawy AR. External aortic compression device: the first aid for postpartum hemorrhage control. J Obstet Gynaecol Res. 2009 Jun;35(3):453-8. doi: 10.1111/j.1447-0756.2008.00975.x.
- Background: PubMed 30768561Kheirabadi BS, Dubick MA. Safe duration of Abdominal Aortic and Junctional Tourniquet application. J Trauma Acute Care Surg. 2019 Sep;87(3):740-741. doi: 10.1097/TA.0000000000002231. No abstract available.
- Background: PubMed 39304012Nieto-Calvache AJ, Palacios-Jaraquemada JM, Aryananda RA, Basanta N, Cininta N, Rivera-Torres LF, Bautista E, Hussein AM. External aortic compression: buying time to save lives in obstetric hemorrhage. Am J Obstet Gynecol. 2025 Feb;232(2):239-241. doi: 10.1016/j.ajog.2024.09.017. Epub 2024 Sep 18. No abstract available.
- Background: PubMed 7818062Riley DP, Burgess RW. External abdominal aortic compression: a study of a resuscitation manoeuvre for postpartum haemorrhage. Anaesth Intensive Care. 1994 Oct;22(5):571-5. doi: 10.1177/0310057X9402200512.
- Background: PubMed 35248574Nieto-Calvache AJ, Palacios Jaraquemada JM, Basanta N, Aryananda RA, Sinisterra-Diaz SE, Rodriguez F, Hidalgo Cardona A, Messa Bryon A. Internal manual compression of the aorta-an effective way to temporarily control pelvic bleeding in obstetrical hemorrhage. Am J Obstet Gynecol. 2022 Jul;227(1):96-97. doi: 10.1016/j.ajog.2022.02.040. Epub 2022 Mar 4.
- Background: PubMed 29626141Khan M, Jeyanathan J, Smith JE. Novel use for the abdominal tourniquet in the management of postpartum haemorrhage. J R Army Med Corps. 2018 Nov;164(6):463. doi: 10.1136/jramc-2018-000953. Epub 2018 Apr 6. No abstract available.
- Information about The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and the sensitive nature of the clinical context, including emergency obstetric care in a war-affected setting. Additional ethical and regulatory considerations related to patient privacy and consent limit the possibility of external data sharing.
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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. This study is not recruiting at the moment.
Viktor Oshovskyy, DMSc, PhD, MD principal investigator
pirhospr@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) in people with Postpartum Haemorrhage (PPH), run by LLC UkrMedGroup at 1 site in Ukraine.
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 1 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: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Bleeding Control After AAJT-S Device Application (time frame: Within 10 minutes of AAJT-S device application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07016568, which also lists 7 linked publications.
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 20 Oct 2025.