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

NCT06721182 | Not Yet Recruiting

• 1 other identifier: AP23487763
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Placenta Accreta Spectrum

Keywords

REBOA; obstetric hemorrhage; cesarean hysterectomy; placenta accreta spectrum; clinical outcome; cesarean section; endovascular balloon occlusion; abnormally invasive placenta

Outcome Measures

Primary Outcomes (1)

• blood loss during cesarean section

  The primary outcome will be a blood loss during cesarean section. Blood Loss will be measured with reference to the collected blood in the suction flask in the surgical theater and the weighted surgical swabs.

  1 year

Study Arms (1)

Intervention group (cesarean section + REBOA)

EXPERIMENTAL

Device: REBOA

Interventions

REBOA DEVICE

endovascular balloon occlusion of the aorta

Intervention group (cesarean section + REBOA)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The following inclusion criteria will be followed for case group: (1) singleton pregnancy at 34 weeks of gestation or more, (2) age 18 to 45 years, (3) confirmed diagnosis of placenta accreta spectrum, (4) indication for elective cesarean section, (5) consent for aortic balloon occlusion during cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Nazarbayev University: lead
• University Medical Center, Kazakhstan: collaborator

Related Publications (3)

• Ioscovich A, Greenman D, Goldin I, Grisaru-Granovsky S, Gozal Y, Zukerman B, Khatib F, Tevet A. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in the Multidisciplinary Management of Morbidly Adherent Placenta. Isr Med Assoc J. 2023 Jul;25(7):462-467.

  PMID: 37461170 BACKGROUND

• Russo RM, Cohen RA. Aortic balloon occlusion in distal zone 3 reduces blood loss from obstetric hemorrhage in placenta accreta spectrum. J Trauma Acute Care Surg. 2024 Feb 1;96(2):e14. doi: 10.1097/TA.0000000000004174. Epub 2023 Oct 18. No abstract available.

  PMID: 37851399 BACKGROUND

• Kluck SL, Russo RM, Appel NB, Frankfurt AI, Weltge C, Shimer T, Feagins B, Frotan A, Rinehart B, Cohen RA. Aortic balloon occlusion in distal zone 3 reduces blood loss from obstetric hemorrhage in placenta accreta spectrum. J Trauma Acute Care Surg. 2023 May 1;94(5):710-717. doi: 10.1097/TA.0000000000003917. Epub 2023 Feb 24.

  PMID: 36812423 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Gauri Bapayeva, MD, PhD

CONTACT

+77017462800; gauri.bapayeva@gmail.com

Milan M Terzic, MD, PhD

CONTACT

+381642802888; milan.terzic@nu.edu.kz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: December 20, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share