Abstract：
OBJECTIVE: While there have been numerous innovations recently for the management of postpartum haemorrhage (PPH), a limited body of research supports their application during this critical complication, which contributes significantly to maternal mortality worldwide. This randomized controlled trial (RCT) aimed to evaluate the effectiveness of three interventions - transvaginal uterine artery clamp (TVUAC), vacuum-assisted uterine contraction using a suction cannula (SC), and condom tamponade (CT) - in the management of atonic PPH.
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.
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.
摘要：
目标：虽然最近在产后出血（PPH）的管理方面有许多创新，有限的研究支持它们在这种严重的并发症中的应用，这对全世界的孕产妇死亡率有很大影响。这项随机对照试验（RCT）旨在评估三种干预措施的有效性-经阴道子宫动脉钳夹（TVUAC），使用抽吸套管（SC）的真空辅助子宫收缩，和避孕套填塞（CT）-在无张力PPH的管理中。
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。
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。
