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Belly tourniquet may buy time for mothers bleeding after birth

NCT ID NCT07016568

Disease control Sponsor: LLC UkrMedGroup Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called the Abdominal Aortic and Junctional Tourniquet (AAJT-S) in 4 women with severe postpartum bleeding that did not stop with standard treatments. The device is a belt placed around the upper belly that inflates to temporarily block blood flow to the pelvis. The goal was to see if it could quickly stop bleeding long enough to prepare for surgery. The study was completed in a war-affected region where resources are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) device
What this could lead to
If successful, this device could provide a quick, non-surgical way to temporarily control life-threatening postpartum bleeding, buying time for definitive treatment in settings with limited resources.
What could go wrong
This is a very small, early proof-of-concept study with only 4 participants, so results may not apply broadly. The device carries risks like blood clots, tissue damage, or technical failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

4 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage Uterine Inertia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postpartum haemorrhage (PPH)

Contacts and locations

Locations

  • Olexandrivska Hospital

    Zaporizhzhia, 69000, Ukraine

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