Postpartum HemorrhageACT-PPHNCT07034924
Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
A study testing Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) in people with Postpartum Hemorrhage, run by LLC UkrMedGroup at 1 site in Ukraine.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- 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
- 20 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jul 2025to Jul 2026
- 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 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 1300 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. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
Olexandrivska Hospital
Zaporizhzhya, 69000
Yevheniia Poliakova, PhD, +380502818399, jenyapolyakova@gmail.com
Viktor Oshovskyy, DMSc, PhD, +380991770303, pirhospr@gmail.com
About this study
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
Read the 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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
- Keywords
- postpartum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
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 |
|---|---|---|
| Participant Group/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.
Efficacy: The proportion of cases achieving rapid hemorrhage control after AAJT-S 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.
Measured: Within 5 minutes of AAJT-S device application
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
Any untoward medical occurrence temporally associated with the AAJT-S device, regardless of causality
Measured: From device application until 6-week postpartum follow-up
Secondary outcomes (1)
Visually estimated blood loss (EBL)
Visually estimated blood loss (EBL) from delivery until AAJT-S placement (mL).
Measured: From delivery until AAJT-S placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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, 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LLC UkrMedGroup
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yevheniia Poliakova, Ph.D, Principal investigator, LLC UkrMedGroup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034924
- Sponsor's protocol ID
- 2025/EC/15051
- Acronym
- ACT-PPH
- Status last verified
- Oct 2025
- First submitted
- 15 Jun 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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
Khan 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 29626141Nieto-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 35248574Riley 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, 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 39304012Kheirabadi 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 30768561Soltan 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 19527382Soltan 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 21676082
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT07034924
- Acronym / sponsor ID
- ACT-PPH / 2025/EC/15051
- Conditions
- Postpartum Hemorrhage
- Keywords
- postpartum hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- LLC UkrMedGroupIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jun 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.
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.
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, 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.
| Arm | Type | Receives |
|---|---|---|
| Participant Group/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 1300 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 | Participant Group/Arm |
Primary outcome
Efficacy: The proportion of cases achieving rapid hemorrhage control after AAJT-S application.
Time frame: 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
Time frame: From device application until 6-week postpartum follow-up
Any untoward medical occurrence temporally associated with the AAJT-S device, regardless of causality
1 secondary outcome
Visually estimated blood loss (EBL)
Time frame: From delivery until AAJT-S placement
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 7 Oct 2025.
- 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.
- 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 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 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 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 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 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.
- 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.
Yevheniia Poliakova, Ph.D principal investigator
LLC UkrMedGroup
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 Hemorrhage, 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: looking for participants now, as of the sponsor's last update on 7 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?
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 Yevheniia Poliakova, Ph.D (+380502818399, jenyapolyakova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: The proportion of cases achieving rapid hemorrhage control after AAJT-S application. (time frame: Within 5 minutes of AAJT-S device application). 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?
On the ClinicalTrials.gov record for NCT07034924, 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 7 Oct 2025.