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.
BackgroundOxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis.MethodsIn two tertiary level Egyptian maternity hospitals, women delivering vaginally without exposure to pre-delivery uterotonics were randomized to one of three prophylactic oxytocin administration groups after delivery of the baby. Blood loss was measured 1 h after delivery, and side effects were recorded. Primary outcomes were mean postpartum blood loss and proportion of women with postpartum blood loss ≥500 ml in this open-label, three-arm, parallel, randomized controlled trial.ResultsFour thousand nine hundred thirteen eligible, consenting women were randomized. Compared to IM injection, mean blood loss was 5.9% less in the IV infusion arm (95% CI: -8.5, − 3.3) and 11.1% less in the IV bolus arm (95% CI: -14.7, − 7.8). Risk of postpartum blood loss ≥500 ml in the IV infusion arm was significantly less compared to IM injection (0.8% vs. 1.5%, RR = 0.50, 95% CI: 0.27, 0.91). No side effects were reported in any arm.ConclusionsIntravenous oxytocin is more effective than intramuscular injection for the prevention of PPH in the third stage of labor. Oxytocin delivered by IV bolus presents no safety concerns after vaginal delivery and should be considered a safe option for PPH prophylaxis.Trial registrationclinicaltrials.gov #NCT01914419, posted August 2, 2013.
The high efficacy, safety, and acceptability of 400-μg sublingual misoprostol indicate that it is analogous to surgery as a first-line treatment for incomplete abortion. Misoprostol might improve post-abortion care when resources are limited and surgical treatment is unavailable.
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