Effectiveness of REBOA in Reducing Blood Loss During Cesarean Section in Patients with PAS

Obstetric hemorrhage is one of the leading causes of maternal mortality and morbidity worldwide. The major risk factors for obstetric hemorrhage include placenta previa and placenta accreta spectrum (PAS) disorders. The frequency of PAS disorders is increasing worldwide and is accompanied by intraoperative massive bleeding with hemorrhagic shock and increasing rates of cesarean hysterectomy. To decrease risks of bleeding, various approached of endovascular balloon occlusion are tested during the recent decade. This study aims to evaluate the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) in reducing blood loss and preserving the reproductive organs during cesarean section. This will be a prospective randomized controlled trial involving 100 patients in tertiary care obstetric center in Kazakhstan. The study population will consist of pregnant women who will be admitted to the University Medical Center for cesarean section due to placenta previa complicated by PAS disorders. Study subjects will be randomly divided in intervention and control groups. The results will be analyzed through the measurement of primary (blood loss during cesarean section) and secondary outcomes \[occurrence of hysterectomy during cesarean section, blood transfusion volume, duration of surgery, balloon application time, stay in intensive care unit (ICU), neonatal outcomes, complications, and total days of postsurgical hospital stay\]. Use of REBOA is expected to minimize intraoperative blood loss during cesarean section, decrease the need for transfusion of blood components, reduce the time of surgical intervention, and decrease the rate of maternal complications and reduce the rate of cesarean hysterectomy.

NCT Number	NCT06721182
Lead Sponsor	Nazarbayev University Collaborators: University Medical Center, Kazakhstan
Conditions	Placenta Accreta Spectrum
Enrollment	100 participants
Start Date	2024-12-20
Primary Completion	2025-12-20 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2024-12-06