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NCT Number: NCT07034924

Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage

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

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Visually estimated blood loss (EBL)

    Time frame: From delivery until AAJT-S placement

    Visually estimated blood loss (EBL) from delivery until AAJT-S placement (mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Viktor Oshovskyy, DMSc, PhD

CONTACT

[email protected]

+380991770303

Yevheniia Poliakova, Ph.D

CONTACT

[email protected]

+380502818399

Sponsors and collaborators

Lead sponsor

LLC UkrMedGroup

Industry

Registry information

Acronym: ACT-PPH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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