CompletedNot Applicable

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

Ukraine4 participantsStarted 2024-12-01

Plain-language 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?

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to Bleeding Control After AAJT-S Device Application

Timeframe: Within 10 minutes of AAJT-S device application

Total Measured Blood Loss (Pre- and Post-intervention)

Timeframe: From onset of PPH until bleeding is definitively controlled (typically within 1-6 hours)

Incidence of Device-related Complications

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

Trial details

NCT IDNCT07016568

SponsorLLC UkrMedGroup

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-15

Results submitted2025-07-30

View on ClinicalTrials.gov More Postpartum Haemorrhage (PPH) trials