The effectiveness and safety of introducing condom‐catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster‐randomised trial

Abstract

ObjectiveTo assess the effectiveness of introducing condom‐catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low‐ and middle‐income settings.DesignStepped wedge, cluster‐randomised trial.SettingEighteen secondary‐level hospitals in Uganda, Egypt and Senegal.PopulationWomen with vaginal delivery from October 2016 to March 2018.MethodsUse of condom‐catheter UBT for PPH management was introduced using a half‐day training and provision of pre‐packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect).Main outcome measuresCombined IR of PPH‐related invasive surgery and/or maternal death.ResultsThere were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH‐related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07–15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods.ConclusionsIntroduction of condom‐catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH‐related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role.Tweetable abstractStepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH‐related surgery or death.

Maternal characteristics and causes associated with refractory postpartum haemorrhage after vaginal birth: a secondary analysis of the WHO CHAMPION trial data

“…If uterine atony was not the main cause of refractory PPH, then the currently recommended treatment interventions would have limited impact to treat this complication, as they mainly target PPH caused by uterine atony. The results of a stepped‐wedge cluster randomised trial of a condom catheter UBT as an option for treatment of unresponsive postpartum bleeding in Egypt, Senegal and Uganda showed that this intervention was ineffective to reduce PPH‐related morbidity and mortality, and raised safety concerns . One of the possible reasons for this negative finding may be that the primary cause of poor outcomes in the study patients was not atony (which is what the UBT was intended to treat) but other causes.…”

Novel suction tube uterine tamponade for treating intractable postpartum haemorrhage: description of technique and report of three cases

“…As reported for other balloon or suction tamponade devices, 2,4,5,[11][12][13] STUT may be carried out postpartum in the labour ward or in the operating theatre, with or without general or regional anaesthesia, after 20 weeks' gestation. Sterile precautions are maintained.…”

“…Two randomised trials have reported poorer outcomes using a fixed volume improvised condom UBT in lowresource settings than without UBT. 4,5 Possible explanations include the balloon preventing the uterus contracting down, the type of balloons used, and implementation factors.…”

Bakri balloon tamponade and condoms catheters are not comparable

“…Moreover, they delay the surgical management of the severe PPH, leading to a high rate of maternal mortality. 2 The major problem of condoms is that they cannot not be inflated more than 250À300 mL, as they explode afterward. In addition; their texture does not allow the efficient compression of the uterine cavity.…”