Temporary Aortic Occlusion With the Abdominal Tourniquet for Refractory Postpartum Haemorrhage: A Proof-of-Concept Study in a War-Affected Region

NCT07016568 | Completed Results DMC

• 1 other identifier: 2024/EC/128094
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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?

Conditions

Postpartum Haemorrhage (PPH)

Keywords

uterine atony; postpartum haemorrhage; Emergency Obstetric Care; Aortic Compression

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From device application through hospital discharge (up to 7 days)

Secondary Outcomes (2)

• Hemodynamic Stabilization Time

  First 60 minutes after AAJT-S application

• Long-term Maternal Recovery Status

  At 6 weeks postpartum

Study Arms (1)

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.

Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Interventions

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.

AAJT-S Device Intervention Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Self-identified females who are biologically capable of pregnancy and childbirth are eligible to participate. The study includes individuals assigned female at birth with a functioning uterus who have delivered vaginally and experienced postpartum hemorrhage. Participation is limited to those with physiologic ability to undergo the obstetric processes being studied.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with postpartum bleeding as a result of trauma, retained placenta or coagulopathy were excluded

Sponsors & Collaborators

• LLC UkrMedGroup: lead

Study Sites (1)

Olexandrivska Hospital

Zaporizhzhia, 69000, Ukraine

Location

Related Publications (7)

• 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.

  PMID: 21676082 BACKGROUND

• Soltan 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.

  PMID: 19527382 BACKGROUND

• Kheirabadi 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.

  PMID: 30768561 BACKGROUND

• Nieto-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.

  PMID: 39304012 BACKGROUND

• Riley 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.

  PMID: 7818062 BACKGROUND

• Nieto-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.

  PMID: 35248574 BACKGROUND

• 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.

  PMID: 29626141 BACKGROUND

Related Links

• Information about The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

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; Dystocia

Limitations and Caveats

* Small sample size prevents generalizability. * No control group. * Estimates of blood loss may be subject to observer bias.

Results Point of Contact

• Title: Yevheniia Poliakova
• Organization: LLC UkrMedGroup

jenyapolyakova@gmail.com

+380502818399

Study Officials

• Viktor Oshovskyy, DMSc, PhD, MD

  pirhospr@gmail.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 11, 2025
• Study Start: December 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)