Uterine Balloon Tamponade for the Treatment of Postpartum Hemorrhage: a Systematic Review and Meta-Analysis.

Abstract

OBJECTIVE\nTo assess the efficacy, effectiveness, and safety of uterine balloon tamponade (UBT) for treating postpartum hemorrhage (PPH).\n\n\nDATA SOURCES\nElectronic databases from their inception to May 2019, and bibliographies.\n\n\nSTUDY ELIGIBILITY CRITERIA\nRandomized controlled trials, non-randomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of UBT in women with PPH.\n\n\nSTUDY APPRAISAL AND SYNTHESIS METHODS\nThe primary outcome was the success rate of UBT for treating PPH (number of UBT success cases/total number of women treated with UBT). For meta-analyses, we calculated pooled success rate for all studies, and relative risk (RR) with 95% confidence intervals (CIs) for studies that included a comparative arm.\n\n\nRESULTS\nNinety-one studies, including 4,729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 non-randomized studies, and 69 case series). The overall pooled UBT success rate was 85.9% (95% CI, 83.9-87.9). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The UBT success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of two randomized trials that compared UBT versus no-UBT in PPH due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (RR 0.59, 95% CI 0.02-16.69). A meta-analysis of two non-randomized before-and-after studies showed that introduction of UBT in protocols for managing severe PPH significantly decreased the use of arterial embolization (RR 0.29, 95% CI 0.14-0.63). A non-randomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used UBT than that which did not use UBT (3.0/1000 vs 5.1/1000; p<0.01). A cluster randomized trial reported that the frequency of PPH-related invasive procedures and/or maternal death was significantly higher after UBT introduction than before UBT introduction (11.6/10,000 vs 6.7/10,000; p=0.04). Overall, the frequency of complications attributed to UBT use was low (≤6.5%).\n\n\nCONCLUSION\nUBT has a high success rate for treating severe PPH and appears to be safe. The evidence on UBT efficacy and effectiveness from randomized and non-randomized studies is conflicting, with experimental studies suggesting no beneficial effect in contrast with observational studies. Further research is needed to determine the most effective programmatic and health care delivery strategies on UBT introduction and use.