Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands.
Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands.
Acta Obstet Gynecol Scand. 2019 Nov;98(11):1473-1482. doi: 10.1111/aogs.13679. Epub 2019 Jul 10.
The aim of this study was to compare the outcomes of women who were initially managed by intrauterine balloon tamponade or uterine artery embolization because of persistent postpartum hemorrhage demanding an immediate intervention to control bleeding.
Propensity score-matched cohort study including women who had intrauterine balloon tamponade or uterine artery embolization as initial management strategy to control persistent postpartum hemorrhage, that is, refractory to first-line therapy combined with at least one uterotonic agent. The primary outcome measure was a composite of peripartum hysterectomy and/or maternal mortality. Secondary outcomes measures were total volume of blood loss and total number of packed red blood cells transfused.
Our 1:1 propensity score-matched cohort comprised of 50 women who had intrauterine balloon tamponade and 50 women who underwent uterine artery embolization at a blood loss between 1000 and 7000 mL. There was no statistically significant difference in the hysterectomy risk between the two groups (n = 6 in each group, odds ratio [OR] 1.00, 95% confidence interval [CI] .30-3.34), in total volume of blood loss (median 4500 mL, interquartile range [IQR] 3600-5400) for balloon vs 4000 mL (IQR 3250-5000) for embolization, P = 0.382) or in total units of packed red blood cells transfused (median 7 (IQR 5-10) for balloon vs 6 [IQR 4-9] for embolization, P = 0.319). Fifteen women (30%) who were initially managed by an intrauterine balloon still underwent uterine artery embolization, of whom one had an embolization-related thrombo-embolic event. Maternal mortality occurred in neither of the intervention groups.
No difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as an initial management for persistent postpartum hemorrhage. Although this study was underpowered to demonstrate equivalence, our study design provides a framework for future research in which intrauterine balloon tamponade may prove to be a suitable intervention of first choice in the management of persistent postpartum hemorrhage.
本研究的目的是比较因持续产后出血而需要立即干预以控制出血的女性，最初采用宫腔球囊填塞或子宫动脉栓塞治疗的结局。
采用倾向评分匹配的队列研究，纳入因持续产后出血而采用宫腔球囊填塞或子宫动脉栓塞作为初始治疗策略以控制出血的女性，即对一线治疗联合至少一种宫缩剂无效的患者。主要结局测量指标为围生期子宫切除术和/或产妇死亡率的复合指标。次要结局测量指标为总失血量和输血量。
我们的 1:1 倾向评分匹配队列包括 50 例接受宫腔球囊填塞和 50 例接受子宫动脉栓塞治疗的患者，失血量为 1000-7000ml。两组间子宫切除术风险无统计学差异（每组 n=6，比值比 [OR] 1.00，95%置信区间 [CI].30-3.34），总失血量（中位数 4500ml，四分位间距 [IQR] 3600-5400）在球囊组与栓塞组分别为 4000ml（IQR 3250-5000），P=0.382）或输血量（中位数 7（IQR 5-10）在球囊组与栓塞组分别为 6（IQR 4-9），P=0.319）。15 例（30%）最初采用宫腔球囊治疗的患者仍接受了子宫动脉栓塞治疗，其中 1 例发生栓塞相关的血栓栓塞事件。两组均无产妇死亡。
宫腔球囊填塞和子宫动脉栓塞作为持续产后出血的初始治疗方法，其围生期子宫切除术和/或产妇死亡的风险无差异。虽然本研究的效力不足以证明等效性，但我们的研究设计为未来的研究提供了一个框架，在未来的研究中，宫腔球囊填塞可能被证明是治疗持续产后出血的首选干预措施。
