High-dose tranexamic acid reduces blood loss in postpartum haemorrhage.

INTRODUCTION: Our purpose in conducting this study was to determine whether administration of high-dose tranexamic acid (TA) at the time of diagnosis of postpartum haemorrhage (PPH) could reduce blood loss. METHODS: This was a randomised, controlled, multicentred, open-label trial. Women with PPH >800 mL following vaginal delivery were randomly assigned to receive TA (loading dose 4 g over 1 hour, then infusion of 1 g/hour over 6 hours) or not. In both groups, packed red blood cells (PRBCs) and colloids could be used according to French guidelines. The use of additional procoagulant treatments was permitted only in cases involving intractable bleeding. The primary objective was to assess the efficacy of TA in the reduction of blood loss in women with PPH, and the secondary objectives were the effect of TA on PPH duration, anaemia, transfusion and the need for invasive procedures. RESULTS: A total of 144 women fully completed the protocol (72 in each group). Blood loss between enrolment and 6 hours later was significantly lower in the TA group than in the control group (median, 173 mL; first to third quartiles, 59 to 377) than in controls (221 mL; first to third quartiles 105 to 564) (P = 0.041). In the TA group, bleeding duration was shorter and progression to severe PPH and PRBC transfusion was less frequent than in controls (P < 0.03). Invasive procedures were performed in four women in the TA group and in seven controls (P = NS). PPH stopped after only uterotonics and PRBC transfusion in 93% of women in the TA group versus 79% of controls (P = 0.016). Mild, transient adverse manifestations occurred more often in the TA group than in the control group (P = 0.03). CONCLUSIONS: This study is the first to demonstrate that high-dose TA can reduce blood loss and maternal morbidity in women with PPH. Although the study was not adequately powered to address safety issues, the observed side effects were mild and transient. A larger international study is needed to investigate whether TA can decrease the need for invasive procedures and reduce maternal morbidity in women with PPH. TRIAL REGISTRATION: Controlled Trials ISRCTN09968140.

Long-term prognosis for infants after massive fetomaternal hemorrhage.

OBJECTIVE: To evaluate the fetal, neonatal, and long-term prognosis of massive fetomaternal hemorrhage (20 mL or more). METHODS: This series includes all patients with Kleihauer test values of 40 per 10,000 or higher over an 8-year period at two university hospitals. We examined obstetric, neonatal, and subsequent outcome data for the children. RESULTS: During the study period, 48 patients had massive fetomaternal hemorrhage (crude incidence 1.1 per 1,000; corrected incidence for Rh-negative women 4.6 per 1,000). Six fetal deaths were observed, representing 1.6% of all fetal deaths during the period. Nine newborns (18.7%) were transferred to neonatal intensive care unit (NICU) and five (10.4%) had transfusions. Fetomaternal hemorrhages of 20 mL/kg or more significantly increased the risk of fetal death, induced preterm delivery, transfer to NICU, and neonatal anemia requiring transfusion. Long-term follow-up was not associated with neurological sequelae (0%, 95% confidence interval 0.0-11.6%). CONCLUSION: When the transfused volume equals or exceeds 20 mL/kg, massive fetomaternal hemorrhage may lead to severe prenatal or neonatal complications. LEVEL OF EVIDENCE: III.

[Maternal pancytopenia during antenatal treatment of congenital toxoplasmosis]. / Pancytopénie maternelle au cours du traitement anténatal d'une toxoplasmose congénitale.

INTRODUCTION: The treatment of reference of congenital toxoplasmosis combines two folate synthesis inhibitors, pyrimethamine and an antibacterial sulfamide (sulfadiazine or sulfadoxine). Despite the efficacy of this combination, the possibility of eventually severe side effects must also be taken into account. OBSERVATION: A pancytopenia occurred at 37 weeks of amenorrhea during antenatal treatment for congenital toxoplasmosis in a tripara. The outcome was positive following administration of strong doses of parenteral folinic acid combined with platelet transfusion and broad-spectrum antibiotics. DISCUSSION: Each of the molecules (pyrimethamine and antibacterial sulfamide) used for the treatment of congenital toxoplasmosis can lead to acute haematological problems. The occurrence of maternal pancytopenia however remains exceptional. It is principally related to pyrimethamine and is usually observed in the presence of factors enhancing folate deficiency.

Medical treatment of ectopic pregnancies: a randomized clinical trial comparing methotrexate-mifepristone and methotrexate-placebo.

BACKGROUND: Medical treatment of ectopic pregnancies is common. To increase the efficacy of methotrexate, the association of mifepristone has been proposed. METHODS: We performed a large prospective multicentre double-blind sequential randomized trial in order to compare the efficacy of methotrexate and mifepristone (600 mg given orally) versus methotrexate and placebo. RESULTS: A total of 212 ectopic pregnancies was randomized. There was no significant difference in the initial characteristics between the two groups. There was no significant difference in the success rate of medical treatment between the methotrexate-mifepristone (n = 113) and the methotrexate-placebo group (n = 99): 79.6% (90/113) versus 74.2% (72/97) respectively, RR (95% CI): 1.07 (0.92-1.25), P = 0.41, non-significant. However, there was a quantitative interaction between progesterone level and effect of treatment: when progesterone level was >/=10 ng/l, the efficacy of the combination of mifepristone and methotrexate was significantly higher than the combination of methotrexate and placebo, with an 83.3% success rate (15/18) versus 38.5% (5/13) respectively. CONCLUSIONS: Our study failed to demonstrate any benefit of the addition of mifepristone to methotrexate. By contrast, the quantitative interaction between treatment effect and baseline serum progesterone suggested that this combination could be limited to ectopic pregnancies associated with high serum progesterone concentrations.

The role of bacterial vaginosis in preterm labor and preterm birth: a case-control study.

OBJECTIVE: To study the association between preterm labor and bacterial vaginosis; in women with preterm labor, to determine whether vaginosis modifies the risk of preterm delivery. STUDY DESIGN: Case-control study. We used Amsel's clinical criteria to test 102 patients hospitalized for preterm labor and 102 control patients for bacterial vaginosis. RESULTS: Patients with preterm labor were diagnosed with bacterial vaginosis significantly more often (13.8%, 95% confidence interval (CI) (7.7-22.0) than control patients (0.0%, 95% CI (0.0-3.6)) (P<0.001). Among the former, the time elapsed to delivery was identical regardless of the patient's bacterial vaginosis status (elapsed time: 35.9 versus 37.1 days, rate of spontaneous preterm birth 42.9 versus 43.2%, not significant). CONCLUSION: Bacterial vaginosis is associated with preterm labor. Nonetheless, it does not appear to predict preterm birth among these patients.