Objective: To study the effect of a low (0.5g) or a standard (1g) tranexamic acid (TA) dose compared to placebo on clinical and biological endpoints in women experiencing postpartum hemorrhage (PPH) Design: TRACES trial is a double-blind, randomized, placebo-controlled, dose-ranging study Setting: 8 women hospitals in France. Population: Women experiencing PPH > 800 mL during caesarean section. Method: After informed consent, patients were randomized to receive either TA 0.5g (n=57), TA 1g (n=58), or a placebo (n=60). Data were collected at 8 time-points. Main outcome measures: Efficacy: additional blood loss after study drug, maternal morbidity, safety, biology: D-dimers, plasmin-antiplasmin complexes (PAP), simultaneous-generation-thrombin-plasmin-potential. Results: Compared to 1g dose, 0.5g TA was less effective to reduce additional blood loss (300 mL [95% confidence interval (95%CI) 68 to 630] vs 134 mL [95%CI50 to 419] (p=0.042)). Compared to placebo, 1g TA, but not 0.5g, inhibited hyperfibrinolysis as shown by plasmin generation potential, % increase in D-dimers from injection to 120 minutes (93% [95%CI 68 to 118] vs 58% [ 95%CI 32 to 84] (p=0.06) vs 38% [95%CI 13 to 63] (p=0.003) and % increase in PAP from injection to 30 minutes (56% [95%CI 25 to 87] vs 13% [ 95%CI 18 to 43] (p=0,051) vs -2% [95%CI -32 to 28] (p=0.009)). Conclusions: In this study, fibrinolysis inhibition was more sustained after the administration of 1g TA compared to 0.5g TA or a placebo. Further pharmacokinetic-pharmacodynamic modelling will be needed to determine the optimal TA dose to be administered in PPH. NCT 02797119

Yasmine Hamoud

and 6 more

Objective: Assess efficacy and safety of labour induction in women with one or more previous caesarean deliveries during second and third trimester pregnancy termination or intrauterine fetal death. Design: Retrospective single-centre study between 2007 and 2018. Setting: Lille, France Population: 136 women with history of previous caesarean deliveries (CD) (study group) and 272 controls undergoing labour induction for pregnancy termination or intrauterine fetal death. Methods: Before 32 weeks, misoprostol 400 μg was given orally every 3 hours up to a maximum of five doses in 24 hours. Study group received half doses. After 32 weeks, oxytocin infusion, misoprostol (PGE1) or PGE2 (dinoprostone) were used according to the Bishop score. Main outcome measures: Vaginal delivery within the 24 hours after induction without uterine rupture or severe post-partum haemorrhage defined as blood loss > 1 litre (PPH). Results: Vaginal delivery within the 24 hours after induction without uterine rupture or PPH was 83.5% in the study group versus 92.6% in the control group (p=0.005). 5 (3.7%) uterine ruptures occurred in the study group, 1.7% in case of one previous CD and 15.8% in case of 2 or more previous CD. There were more severe PPH in the study group (6.7% versus 2.2% p=0.03), but no difference was found between women with one or more previous CD. Conclusions: Women with 2 or more prior CD should be informed that they are at higher risk of complications such as uterine rupture and severe post-partum haemorrhage.

Melissa Gilbert

and 6 more

Harmonie Dupuis

and 5 more

Objective - This study aims to assess fetal physiology training in terms of theoretical knowledge, fetal heart rate interpretation and use of second-line examination. Design - - Single-center prospective study (CHU Lille, France) Setting - The evaluation of fetal well-being during labor is based on fetal heart rate (FHR) analysis and requires knowledge of physiology. Population - Obstetrics and gynecology residents from November 2017 to November 2018 (n=34) Methods – The training was conducted in 3 steps: a session of FHR interpretation and the use of fetal scalp blood sampling (FBS) on clinical cases, then a teaching session on fetal physiology, and finally another session on the same cases presented in the first one. Main Outcome Measures – Theoretical knowledge evaluation (MCQs), number of FBS requested, the reproducibility of responses. Results - Almost 3% estimated their training sufficient on fetal physiology, 11.8% on fetal heart rate analysis and 14.7% on second-line examination. The training allowed a significant improvement of their theoretical knowledge evaluation (mediane [IQR] : 1.5[1.0 to 2.0] vs 4.0[3.0 to 4.5] of MCQs, p <0.001)), a decrease in the number of FBS requested (36.3% vs 29.5%, p =0.002). The Krippendorff’s alpha index assessing the reproducibility of their response was significantly improved, reflecting a better homogenization of practices (alpha [IC95] : 0.60[0.55 to 0.65] vs 0.72[0.67 to 0.76]). Conclusions - The improvement of knowledge in fetal physiology allows a better interpretation of the FHR with better indications of second-line examinations and a homogenization of practices. Funding- None