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.

Background600 mcg of oral misoprostol reduces the incidence of postpartum haemorrhage (PPH), but in previous research this medication has been administered by health workers. It is unclear whether it is also safe and effective when self-administered by women.MethodsThis placebo-controlled, double-blind randomised trial enrolled consenting women of at least 34 weeks gestation, recruited over a 2-month period in Mbale District, Eastern Uganda. Participants had their haemoglobin measured antenatally and were given either 600mcg misoprostol or placebo to take home and use immediately after birth in the event of delivery at home. The primary clinical outcome was the incidence of fall in haemoglobin of over 20 % in home births followed-up within 5 days.Results748 women were randomised to either misoprostol (374) or placebo (374). Of those enrolled, 57 % delivered at a health facility and 43 % delivered at home. 82 % of all medicine packs were retrieved at postnatal follow-up and 97 % of women delivering at home reported self-administration of the medicine. Two women in the misoprostol group took the study medication antenatally without adverse effects. There was no significant difference between the study groups in the drop of maternal haemoglobin by >20 % (misoprostol 9.4 % vs placebo 7.5 %, risk ratio 1.11, 95 % confidence interval 0.717 to 1.719). There was significantly more fever and shivering in the misoprostol group, but women found the medication highly acceptable.ConclusionsThis study has shown that antenatally distributed, self-administered misoprostol can be appropriately taken by study participants. The rarity of the primary outcome means that a very large sample size would be required to demonstrate clinical effectiveness.Trial registrationThis study was registered with the ISRCTN Register (ISRCTN70408620).

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This study shows variability in Cmax and AUC by three by-mouth routes of misoprostol administration. The dose in this study was 800 μg, which is among the highest doses seen in current guidelines. These data contribute to the understanding of efficacy and safety of different routes and could provide a basis for deciding whether certain routes are preferable for particular indications.

(BJOG. 2019;126:1612–1621) The World Health Organization has recommended uterine balloon tamponade (UBT) as one intervention for postpartum hemorrhage (PPH), a leading cause of maternal mortality worldwide. This is important for low- and middle-income countries (LMICs), where uterotonics, blood products, and skilled surgical teams may not be readily available. A few studies have reviewed the use of condom-catheter UBT in LMICs, but they have demonstrated conflicting findings or lacked robust evidence on its effectiveness. The aim of this study was to examine if condom-catheter UBT reduced maternal morbidity and mortality associated with PPH in LMICs.