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Prophylactic and Resuscitative Endovascular balloon in Gynecology & Obstetrics (PREGO) TRIAL
Background-
REBOA has been used by acute care surgeons for the last 9 years in civilian and military settings to temporize non-compressible torso hemorrhage. PPH is a top etiology of maternal mortality in the US and even more so abroad. The skillset is being used more frequently in some institutions as a method of temporizing peri-partum and primary or secondary post-partum hemorrhage. Massive transfusion events can be initiated in the setting of PPH and temporization of PPH traditionally occurs with blood products and at least one procedure or intervention (hysterectomy, intra-uterine balloon, embolization, pelvic packing). Acute care surgeons have been called to respond to the initiation of massive transfusion events for these patients or consulted urgently for hemorrhage control in the operating room or L&D suite. In other instances, interventional radiologists are called to place bilateral internal iliac balloons for hemorrhage control, which has its own set of limitations as described in the limited published series available. Bilateral internal iliac artery occlusion has not been widely adopted as IR is not always available, cannot perform this procedure without fluoroscopy, and are not in the hospital at all hours. For some institutions this has led to protocols where consultation with the acute care surgery service occurs prior to a high-risk delivery, C-section (with or without planned hysterectomy) so that CFA access can be established prior to the operation, and rapidly upsized for REBOA if needed. In other centers, the balloon catheter is placed in patients prior to the C-section in order to reduce blood loss and minimize complications as suggested by the limited data available.
The Joint Commission has recently published the Provision of Care, Treatment, and Services (PC) chapter (PC.06.01.01 and PC.06.01.03) designed to improve the quality and safety of care provided to women during all stages of pregnancy and postpartum. Because of worsening maternal morbidity and mortality from hemorrhage, The Joint Commission evaluated expert literature to determine what areas held the most potential impact. The literature review revealed that prevention, early recognition, and timely treatment for maternal hemorrhage had the highest impact in states working on decreasing maternal complications. Starting July 2020, 13 new elements of performance will be reviewed by accredited hospitals in order to remain compliant by demonstrating quality improvement measures are in place to reduce maternal deaths from hemorrhage. REBOA is already in use for this purpose in a small number of centers and has the potential to be a game-changer in this field. New devices are currently FDA-approved, including balloon catheters compatible with 4Fr sheaths. Advances in technology, combined with clinical data, may amplify the use of REBOA for PPH. Initiatives for hemorrhage control with OB/GYN colleagues should be encouraged, as acute care surgeons are able to not only help temporize or manage hemorrhage control, but can also aid in the resuscitation and post-operative critical care of these patients.
REBOA can be a beneficial skillset in the toolkit of the rescue surgeon for PPH. The indications, protocols, and data for its use in this setting have yet to be defined.
The study aim is to collect retrospective and prospective observational data on the use of REBOA for PPH and compare to patients with PPH who do not receive REBOA. The secondary aim is to develop recommendations for use of REBOA for PPH in this patient population. Inclusion criteria are pregnant or post-partum patients with peri-partum hemorrhage prior to delivery or within 12 weeks after delivery (ACOG definition of peri-partum hemorrhage) who receive REBOA and/or other adjuncts for hemorrhage control. Primary outcome measures include blood product transfusions, estimated blood loss (EBL), preservation of uterus, procedure start/end times, maternal and newborn ICU days/ventilator days/hospital days. Secondary outcomes include access and systemic complications, post-operative ileus, Apgar scores, maternal, fetal, and newborn mortality. The 2 groups (REBOA and no REBOA) will be compared.
PI: Megan Brenner (University of California Riverside)
Co-PI(s): Laura Moore (University of Texas at Houston), Karin Fox (Texas Children’s Hospital, Baylor College of Medicine)
References:
Ioffe Y, Burruss S, Yao R, Tse B, Cryer A, Mukherje K, Hong L. When the balloon goes up, blood transfusion goes down: a pilot study of REBOA in placenta accreta spectrum disorders. Trauma Surg Acute Care Open 2021 Aug 13;6(1):e000750. PMID: 34466661
Riazanova OV, Reva VA, Fox KA, Romanova LA, Kulemin ES, Riazanov AD, Ioscovich A. Open versus endovascular REBOA control of blood loss during cesarean delivery in the placenta accreta spectrum: A single-center retrospective case control study. Eur J Obstet Gynecol Reprod Biol. 2021 Mar;258:23-28. doi: 10.1016/j.ejogrb.2020.12.022. Epub 2020 Dec 13.PMID: 33388487