SummaryBackgroundPost-partum haemorrhage is the leading cause of maternal death worldwide. Early administration of tranexamic acid reduces deaths due to bleeding in trauma patients. We aimed to assess the effects of early administration of tranexamic acid on death, hysterectomy, and other relevant outcomes in women with post-partum haemorrhage.MethodsIn this randomised, double-blind, placebo-controlled trial, we recruited women aged 16 years and older with a clinical diagnosis of post-partum haemorrhage after a vaginal birth or caesarean section from 193 hospitals in 21 countries. We randomly assigned women to receive either 1 g intravenous tranexamic acid or matching placebo in addition to usual care. If bleeding continued after 30 min, or stopped and restarted within 24 h of the first dose, a second dose of 1 g of tranexamic acid or placebo could be given. Patients were assigned by selection of a numbered treatment pack from a box containing eight numbered packs that were identical apart from the pack number. Participants, care givers, and those assessing outcomes were masked to allocation. We originally planned to enrol 15 000 women with a composite primary endpoint of death from all-causes or hysterectomy within 42 days of giving birth. However, during the trial it became apparent that the decision to conduct a hysterectomy was often made at the same time as randomisation. Although tranexamic acid could influence the risk of death in these cases, it could not affect the risk of hysterectomy. We therefore increased the sample size from 15 000 to 20 000 women in order to estimate the effect of tranexamic acid on the risk of death from post-partum haemorrhage. All analyses were done on an intention-to-treat basis. This trial is registered with ISRCTN76912190 (Dec 8, 2008); ClinicalTrials.gov, number NCT00872469; and PACTR201007000192283.FindingsBetween March, 2010, and April, 2016, 20 060 women were enrolled and randomly assigned to receive tranexamic acid (n=10 051) or placebo (n=10 009), of whom 10 036 and 9985, respectively, were included in the analysis. Death due to bleeding was significantly reduced in women given tranexamic acid (155 [1·5%] of 10 036 patients vs 191 [1·9%] of 9985 in the placebo group, risk ratio [RR] 0·81, 95% CI 0·65–1·00; p=0·045), especially in women given treatment within 3 h of giving birth (89 [1·2%] in the tranexamic acid group vs 127 [1·7%] in the placebo group, RR 0·69, 95% CI 0·52–0·91; p=0·008). All other causes of death did not differ significantly by group. Hysterectomy was not reduced with tranexamic acid (358 [3·6%] patients in the tranexamic acid group vs 351 [3·5%] in the placebo group, RR 1·02, 95% CI 0·88–1·07; p=0·84). The composite primary endpoint of death from all causes or hysterectomy was not reduced with tranexamic acid (534 [5·3%] deaths or hysterectomies in the tranexamic acid group vs 546 [5·5%] in the placebo group, RR 0·97, 95% CI 0·87-1·09; p=0·65). Adverse events (including thromboembolic events) did not differ significantly in the tranexamic acid versus ...

Objectives. To assess the effect of 2-way short message service (SMS) with a nurse on postpartum contraceptive use among individual women and couples. Methods. From 2016 to 2017, we conducted a randomized controlled trial at 2 public hospitals in western Kenya. We assigned eligible pregnant women to receive 2-way SMS with a nurse or no SMS, with the option to include male partners. We delivered automated family planning–focused SMS messages weekly until 6 months postpartum. Women and men receiving SMS could interact with nurses via SMS. In intention-to-treat analysis, we compared highly effective contraceptive (HEC) use at 6 months postpartum between groups using the χ2 test. We used Poisson regression in adjusted analysis. Results. We randomized 260 women to 2-way SMS or control, and we enrolled 103 male partners. At 6 months postpartum, 69.9% women receiving SMS reported HEC use, compared with 57.4% in control (relative risk = 1.22; 95% confidence interval [CI] = 1.01, 1.47; P = .04). In analysis adjusted for baseline demographic differences, the adjusted relative risk for HEC use in the SMS group was 1.26 (95% CI = 1.04, 1.52; P = .02). Conclusions. Two-way SMS with a nurse, including optional male participation, increased postpartum contraceptive use. Trial Registration. ClinicalTrials.gov; identifier: NCT02781714.

Background HIV testing male partners of pregnant women may decrease HIV transmission to women and promote uptake of prevention of mother-to-child HIV transmission (PMTCT) interventions. However, it has been difficult to access male partners in antenatal care (ANC) clinics. We hypothesized that home visits to offer HIV testing to partners of women attending ANC would increase partner HIV testing. Methods Women attending their first ANC were enrolled, interviewed using smartphone audio-computer assisted self-interviews and randomized to home visits or written invitations for male partners to come to clinic, if they were married or cohabiting, unaccompanied by partners and had no prior couple HIV counseling and testing (CHCT). Enrolled men were offered CHCT (HIV testing and mutual disclosure). Prevalence of CHCT, male HIV seropositivity, couple serodiscordance, and intimate partner violence, reported as physical threat from partner, were compared at 6 weeks. Results Among 495 women screened, 312 were eligible, and 300 randomized to clinic-based or home-based CHCT. Median age was 22 years (interquartile range 20, 26), and 87% were monogamous. CHCT was significantly higher in home-visit than clinic-invitation arm (n=128, 85% vs n=54, 36%; p<0.001). Home-arm identified more HIV-seropositive men (12.0 % vs 8.0 %; p= 0.248) and more HIV-discordant couples (14.7% vs 4.7%; p=0.003). There was no difference in intimate partner violence. Conclusion Home visits of pregnant women were safe and resulted in more male partner testing and mutual disclosure of HIV status. This strategy could facilitate prevention of maternal HIV acquisition, improve PMTCT uptake, and increase male HIV diagnosis.

Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).

Background Maternal infections are an important cause of maternal mortality and severe maternal morbidity. We report the main findings of the WHO Global Maternal Sepsis Study, which aimed to assess the frequency of maternal infections in health facilities, according to maternal characteristics and outcomes, and coverage of core practices for early identification and management.Methods We did a facility-based, prospective, 1-week inception cohort study in 713 health facilities providing obstetric, midwifery, or abortion care, or where women could be admitted because of complications of pregnancy, childbirth, post-partum, or post-abortion, in 52 low-income and middle-income countries (LMICs) and high-income countries (HICs). We obtained data from hospital records for all pregnant or recently pregnant women hospitalised with suspected or confirmed infection. We calculated ratios of infection and infection-related severe maternal outcomes (ie, death or near-miss) per 1000 livebirths and the proportion of intrahospital fatalities across country income groups, as well as the distribution of demographic, obstetric, clinical characteristics and outcomes, and coverage of a set of core practices for identification and management across infection severity groups.