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 ...

Objective To determine whether hyoscine butylbromide shortens the first stage of labour, without an increase in maternal or neonatal complications.Design Randomised, double-blinded, controlled trial.Setting The Antenatal clinics and Labour and Delivery ward of the University Hospital of the West Indies, Kingston, Jamaica.Population Women in spontaneous labour at term.Methods Either drug or placebo was given intravenously once the women entered active labour.Main outcome measures The duration of the first stage of labour. Secondary outcomes included comparisons of the duration of the second and third stages of labour, blood loss at delivery, rate of caesarean section, and APGAR scores in the neonates between the two groups.Results A total of 129 women yielded data for analysis. Of these, 69 women received the placebo and 60 received hyoscine butylbromide. The mean time for the first stage in the control group was 228 minutes, compared with 156 minutes in the drug group, representing a decrease of 31.7% (P = 0.001). There was no significant change in the duration of the second and third stages of labour, and no difference in blood loss or in APGAR scores. There was a slight (but statistically insignificant) increase in the caesarean section rate.Conclusion Hyoscine butylbromide is effective in significantly reducing the duration of the first stage of labour, and it is not associated with any obvious adverse outcomes in mother or neonate.

Objective To determine if misoprostol (exogenous prostaglandin E, PGE,) used vaginally was of value in improving the Bishop score, leading to an early safe vaginal delivery in women in whom the cervix is unripe and delivery is indicated.Design A double-blind clinical trial.Setting Antenatal and labour wards of the University Hospital of the West Indies, Jamaica.Subjects Forty-five women in the third trimester with various obstetric indications for induction of labour and with no contra-indications to prostaglandins. InterventionsThe women were randomly assigned to receive treatment or a placebo. The treated group had 100 pg misoprostol inserted vaginally while the placebo was similarly inserted.Main outcome measures Efficacy of the misoprostol was measured by the increase in the Bishop score 12 h after giving the treatment, the time between insertion and delivery, the need for oxytocin, and the outcome of the pregnancy. ResultsThe prostaglandin was superior to the placebo in ripening the cervix and inducing labour. The change in Bishop score was 5-3 in the misoprostol group compared with 1.5 in the placebo group (P

Objective To assess the efficacy of intramyometrial vasopressin for minimising bleeding and its sequelae at myomectomy. Design A randomised placebo controlled trial. Setting University Hospital of the West Indies, Kingston, Jamaica. Subjects Twenty women with symptomatic uterine fibroids scheduled for myomectomy who satisfied entry criteria: 10 randomised to the vasopressin group and 10 to the control group. Intervention Myomectomy was performed after the intramyometrial injection of either 20 units vasopressin diluted to 20 ml in normal saline or placebo (20 ml normal saline). Main outcome measures The efficacy of vasopressin was measured by comparing pre‐ and post‐operative haemoglobin levels and haematocrit, changes in intra‐operative pulse and blood pressure, measured blood loss, need for blood transfusion and post‐operative febrile morbidity in the treatment and control groups. Results The use of vasopressin resulted in median blood loss of 225 ml (range 150–400 ml) compared with 675 ml (range 500–800 ml) in the placebo group (P < 0.001). The vasopressin group had a correspondingly lower fall in haemoglobin level (median 1.7g/dl vs 5.3 g/dl, P < 0.001) and haematocrit (median 5%vs 13%, P < 0.001) compared with the controls. Fifty percent of the placebo group had blood transfusions compared with none in the vasopressin group (P= 0.03). There were no significant differences between the groups in intra‐operative pulse and blood pressure or post‐operative white blood cell counts or temperature. Conclusion The results indicate that vasopressin is effective in preventing blood loss and reducing the need for blood transfusion during myomectomy.

Vasopressin prevents blood loss better than using the tourniquet during myomectomy.