Postpartum haemorrhage management: A randomized controlled trial comparing transvaginal uterine artery clamp, vacuum-assisted uterine contraction and condom tamponade

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 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 f 187 ml) and SC (246.5 f 189 ml) groups. However, following the use of CT, there was blood loss of 431 f 427 ml, although this difference was not significant (p p = 0.113). When considering total blood loss, the TVUAC group (903 f 234 ml) showed slightly higher values than the SC group (887 f 184 ml). However, the CT group exhibited notably higher total blood loss (1068 f 455 ml) than the TVUAC and SC groups. In terms of application time, both TVUAC (1.8 f 1.1 min) and SC (1.6 f 0.9 min) significantly outperformed CT (3 f 1.3 min) (p 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 f 4 min) and the SC group (5.7 f 1.6 min) compared with the CT group (9.7 f 3.8 min) (p 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.