Objective: Postpartum hemorrhage is a leading cause of maternal mortality and morbidity around the globe. The novel low-suction vacuum hemorrhage device (VHD) provides an alternative treatment option for cases of postpartum hemorrhage when first-line uterotonic agents fail. This systematic review aims to review current data evaluating the overall efficacy and safety of VHDs in treating postpartum hemorrhage.
Methods: We searched CINAHL Ultimate, Academic Search Premier, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, MEDLINE with Full Text, and PubMed and reference lists of retrieved studies for eligible studies that included outcomes of effectiveness, efficacy, or safety. Two independent reviewers used Covidence.org to screen Titles and Abstracts for 69 studies of which six were included in the analysis. Secondary outcomes measured across studies included time to bleeding control, total device deployment time, and adverse effects.
Results: Six nonrandomized trials (N = 1018 participants) included studies conducted in Indonesia, the United States, Switzerland, and Canada. The VHDs were found to have 90% effectiveness in achieving bleeding control across the studies. For most patients, this was achieved in <5 min and required a total device deployment time of 3 h. Reported adverse events were not considered life-threatening, including endometritis in 11 patients and red blood cell transfusions in 38% of patients.
Conclusion: VHDs have the potential to be used as a rapidly effective means for mechanical intervention of postpartum hemorrhage. The efficacy and safety of VHDs must be further studied at the randomized controlled trial level to determine their clinical usage.
Keywords: JadaⓇ System; Vacuum-induced hemorrhage control; hemorrhage; maternal mortality; vacuum tamponade.