Temporary abdominal aortic compression with the AAJT-S for severe postpartum bleeding
Official title: Temporary Aortic Compression With the Abdominal Tourniquet for Refractory Postpartum Hemorrhage
Run by LLC UkrMedGroup · NCT07034924 · Data updated 2026-11-12
This will try using the AAJT-S abdominal tourniquet to stop severe postpartum bleeding in women whose bleeding does not stop with usual treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | LLC UkrMedGroup Industry-sponsored |
| Locations | 1 site (Zaporizhzhya) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | June 2026 |
| Study ends | July 2026 |
| Registry record updated | October 7, 2025 |
| Trial ID | NCT07034924 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Postpartum women aged 18 or older with primary PPH (estimated blood loss >1300 mL) from uterine atony that has not responded to uterotonics and balloon tamponade, who can provide oral informed consent prior to device application, are the intended candidates.
✕Probably not a fit
Patients whose bleeding is due to trauma, retained placental tissue, or primary coagulopathy (all exclusion criteria) are unlikely to benefit from this aortic compression approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, single-arm study in conflict-affected regions of Ukraine testing the AAJT-S abdominal aortic and junctional tourniquet as a temporary measure for severe PPH due to uterine atony that is refractory to uterotonics and intrauterine balloon tamponade. When eligibility is confirmed and standard measures have failed, the AAJT-S is applied to the upper abdomen and inflated to 250 mmHg to temporarily occlude the abdominal aorta and reduce pelvic blood flow. The study will collect feasibility, safety, and clinical effectiveness outcomes including control of bleeding, need for definitive surgery or hysterectomy, transfusion requirements, and device-related adverse events. The intent is to buy time to assemble surgical teams, initiate transfusion, and establish anesthesia where access to definitive care may be delayed.
Why it matters
Potential benefit: If successful, the device could rapidly reduce pelvic blood loss and buy critical time to reach definitive care, potentially lowering mortality, transfusion needs, and emergency hysterectomy rates.
How similar studies have gone: Aortic and junctional tourniquets have shown some success in trauma and emergency settings, but their use specifically for refractory PPH is relatively novel with only limited case reports and small series.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Olexandrivska Hospital
Zaporizhzhya, Ukraine Recruiting
Study contacts
- Principal investigator: Yevheniia Poliakova, Ph.D — LLC UkrMedGroup
- Study coordinator: Yevheniia Poliakova, Ph.D
- Email: jenyapolyakova@gmail.com
- Phone: +380502818399
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-term outcomes after vacuum-induced tamponade for postpartum hemorrhage
This study will look at women who had postpartum hemorrhage treated with vacuum-induced tamponade at a Zurich hospital to see how they fared over time, including future pregnancies and fertility.
-
Calcium Gluconate After Birth to Reduce Blood Loss in Vaginal Delivery
This study tests whether giving calcium gluconate right after the baby is born can help reduce blood loss for people having a vaginal delivery.
-
Carbetocin Alone vs Carbetocin Plus Oxytocin After Elective Cesarean Delivery
This study tests whether giving carbetocin by itself after an elective cesarean is just as good as adding a supplemental oxytocin infusion.
-
Simulation-based postpartum hemorrhage training to boost anesthesiology team performance
Senior anesthesiology residents will try a high-fidelity simulation program for postpartum hemorrhage to see if it improves how their teams perform during obstetric emergencies.
-
Carbetocin to prevent heavy bleeding after twin birth
This trial tests whether a single dose of carbetocin given after the second twin is born reduces heavy bleeding compared with standard oxytocin in people delivering twins.
-
Draining the umbilical cord after birth to lower postpartum bleeding
This trial tests whether draining blood from the cut umbilical cord right after birth lowers heavy bleeding after delivery in women having a term vaginal birth.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.