METHODS: An open-label RCT was conducted among women who delivered vaginally and developed atonic PPH at a tertiary care obstetric facility. Block randomization with sealed envelopes was used to allocate eligible participants into three interventional arms with a 1:1:1 ratio. The exclusion criteria were twin deliveries, haemodynamically unstable patients, and individuals who did not provide informed consent. The primary outcome variables assessed were blood loss post-application, total blood loss, time taken for application, and time required to achieve haemostasis within each trial arm. The secondary outcomes were the need for a second instrument or surgical intervention to control bleeding, and requirement for blood transfusion. Effectiveness outcomes were analysed as intention-to-treat, whilst safety outcomes were analysed as as-treated.
RESULTS: Sixteen participants were randomized to each intervention group (n = 48). TVUAC and SC demonstrated comparable outcomes, while CT lagged in all examined parameters. Following device application, blood loss was similar in both the TVUAC (235 ± 187 ml) and SC (246.5 ± 189 ml) groups. However, following the use of CT, there was blood loss of 431 ± 427 ml, although this difference was not significant (p = 0.113). When considering total blood loss, the TVUAC group (903 ± 234 ml) showed slightly higher values than the SC group (887 ± 184 ml). However, the CT group exhibited notably higher total blood loss (1068 ± 455 ml) than the TVUAC and SC groups. In terms of application time, both TVUAC (1.8 ± 1.1 min) and SC (1.6 ± 0.9 min) significantly outperformed CT (3 ± 1.3 min) (p = 0.002). Furthermore, the time interval from the diagnosis of PPH to achieving haemostasis (defined as the time taken for active haemostasis) was significantly shorter in the TVUAC group (6 ± 4 min) and the SC group (5.7 ± 1.6 min) compared with the CT group (9.7 ± 3.8 min) (p = 0.002).
CONCLUSIONS: TVUAC and SC are more effective for the management of PPH than CT. However, both TVUAC and SC have advantages and disadvantages. While these results suggest a potential preference for TVUAC and SC over CT for the management of PPH, further research is necessary to validate these findings.
方法:在三级护理产科设施中,对阴道分娩并发展为无张力PPH的妇女进行了开放标签RCT。使用密封信封的分组随机化将符合条件的参与者以1:1:1的比例分配到三个介入组。排除标准是双胎分娩,血流动力学不稳定的患者,以及未提供知情同意书的个人。评估的主要结果变量是应用后的失血量,总失血量,申请时间,以及在每个试验组中实现止血所需的时间。次要结果是需要第二种器械或手术干预来控制出血,和输血的要求。有效性结果被分析为意向治疗,而安全性结局作为治疗进行分析.
结果:16名参与者被随机分配到每个干预组(n=48)。TVUAC和SC表现出可比的结果,而CT在所有检查参数中都滞后。在设备应用之后,TVUAC(235±187ml)和SC(246.5±189ml)组的失血量相似.然而,在使用CT之后,失血431±427毫升,尽管这种差异并不显著(p=0.113)。当考虑到总失血时,TVUAC组(903±234ml)的值略高于SC组(887±184ml)。然而,CT组的总失血量(1068±455ml)明显高于TVUAC和SC组。在申请时间上,TVUAC(1.8±1.1min)和SC(1.6±0.9min)均显著优于CT(3±1.3min)(p=0.002).此外,与CT组(9.7±3.8min)相比,TVUAC组(6±4min)和SC组(5.7±1.6min)从PPH诊断到止血的时间间隔(定义为主动止血所需的时间)显著缩短(p=0.002).
结论:TVUAC和SC对PPH的管理比CT更有效。然而,TVUAC和SC都有优点和缺点。虽然这些结果表明,对于PPH的管理,TVUAC和SC可能优于CT,需要进一步的研究来验证这些发现。