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 = 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.

Crash Caesarean Delivery: How to Optimise Decision-to-Delivery Interval by Initiating a Novel Code? A Clinical Audit.

Background: Many resource-constrained centres fail to meet the international standard of 30 min of decision-to-delivery interval (DDI) of Category-1 crash caesarean deliveries. However, specific scenarios like acute foetal bradycardia and antepartum haemorrhage necessitate even faster interventions. Methods: A multidisciplinary team developed a "CODE-10 Crash Caesarean" rapid response protocol to limit DDI to 15 min. A multidisciplinary committee analysed a retrospective clinical audit of maternal-foetal outcomes over 15 months (August 2020-November 2021), and expert recommendations were sought. Results: The median DDI of twenty-five patients who underwent a "CODE-10 Crash Caesarean delivery" was 13 ± 6 min, with 92% (23/25) of DDIs falling below 15 min. Seven neonates required intensive care for more than 24 h with no maternal or neonatal mortality. DDIs during office and non-office hours were not significantly different (12.5 ± 6 min vs 13 ± 5 min, p = 0.911). Transport delays caused the two instances of DDI > 15 min. Conclusion: The novel "CODE-10 Crash Caesarean" protocol may be feasible for adoption in a similar tertiary-care setting with appropriate planning and training.

Managing placenta accreta spectrum in low-resource settings using a novel dissection-free aorta clamp: Operative technique.

OBJECTIVE: Surgical management of Placenta accreta spectrum (PAS) is associated with profuse bleeding and increased risk of operative injury to the adherent pelvic structures. We propose using a novel aorta clamp that can occlude the abdominal aorta without retroperitoneal dissection, thereby making it easy for an obstetrician-gynecologist to use it. The novel Paily aorta clamp (PAC) is applied just above the bifurcation of the abdominal aorta. METHODS: This was a retrospective study of 33 women with varying grades of histopathology-confirmed PAS, who were managed as an elective or emergency procedure in a tertiary center in India. RESULTS: Twenty-nine women with advanced grades of PAS underwent sub-total/total hysterectomies, while four women with low-grade PAS underwent a conservative procedure. The procedures were associated with median estimated intra-operative blood loss of 1000 ± 1500 ml, with only 21.2% (n = 7) requiring a transfusion of four or more units packed red blood cells. PAC was applied for a median of 55 ± 20 min and was not associated with any perioperative aortic wall injury or distal thromboembolic phenomenon. CONCLUSION: Our experience using the novel PAC, in the current series and across multiple centers in India, demonstrates that the sizeable abdominal aorta can be clamped safely and effectively without retroperitoneal dissection-with no incidence of vascular injury so far. However, we would urge only designated centers with experienced obstetrician-gynecologists-backed by a urologist, adequate blood bank and intensive care facilities-to tackle PAS procedures using the PAC technique.

Arresting post-partum hemorrhage using the novel trans-vaginal uterine artery clamp.

OBJECTIVES: Post-partum hemorrhage (PPH) continues to be the leading cause of maternal mortality in low-resource settings. The commonest variant - Atonic PPH, is managed by additional pharmacological measures which may fail. Additional surgical interventions for hemostasis take time and are not universally available. Immediate arrest of bleeding was deemed essential and a novel Transvaginal Uterine Artery Clamp (TVUAC) was explored for its effectiveness in achieving immediate hemostasis in atonic and mixed post-partum hemorrhage. STUDY DESIGN: A retrospective chart review was performed for all patients, who underwent vaginal delivery and developed immediate post-partum atonic PPH, in a tertiary care center in South India, between 1st April 2015 and 31st December 2020. As soon as excess bleeding was observed, two TVUACs were applied trans-vaginally at 3' and 9'o clock position of the cervix to occlude the uterine arteries where it joins the isthmus of the uterus. RESULTS: Of 3999 vaginal deliveries, there were 251 patients who developed primary atonic PPH during the study period, of which 89 were managed by medical measures alone. Out of the remaining 162 patients, in 153 (94.4%) TVUAC helped to achieve hemostasis; with TVUAC alone in 120 patients (78.43%) and with an additional second line surgical intervention in 33 patients. In nine patients, TVUAC was not readily available and hence second line interventions alone were used. None required any third line surgical interventions (laparotomies) for hemostasis nor were there any incident of maternal mortality or consumptive coagulopathy. TVUAC was applied for a mean duration of 25 ± 10 min. Only 11.6% (29/251, 95% C.I 7.9-16.1%) of the patients required a blood transfusion with a median of 2 (1-4) units of packed RBC. No procedure related complications were reported up to a scheduled 6th week in-person follow-up. CONCLUSION: The novel TVUAC shows potential in limiting third line interventions, maternal morbidity and mortality. Its effectiveness and safety may be further explored as a first line surgical adjunct to medical measures, in PPH protocols in low-resource settings.