The challenge of defining women at low-risk for childbirth: analysis of peripartum severe acute maternal morbidity in women considered at low-risk according to French guidelines.

Context, objective Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality and the main component of severe maternal morbidity in developed countries. Decreasing the prevalence of severe PPH is a major obstetrical challenge. In most cases, these are considered to be associated with substandard care. A number of PPH-related clinical guidelines have therefore been developed, both nationally and internationally. The harder job, however, is ensuring the actual translation of these guidelines into clinical practice. Guidelines do not by themselves change professionals’ practices, and the effectiveness of active intervention strategies must be assessed. We tested the hypothesis that a multifaceted educational intervention, aimed at improving practices for PPH management, would reduce the incidence of severe PPH. Methods In a cluster-randomised trial spanning 6 regions in France, 106 maternity units (accounting for 17% of French maternity units, and 20% of deliveries nationwide) were randomly assigned to receive a multi-faceted intervention -combining outreach visits, reminders, and peer reviews of severe cases- to implement a protocol for early management of PPH, or to have the protocol passively disseminated. The primary outcome was the incidence of severe PPH, defined as a composite of one or more of the following: transfusion, embolisation, surgery, transfer to intensive care, peripartum haemoglobin delta of 4 g/dl or more, or death. The main secondary outcomes were the rates of the principal procedures for PPH management recommended in the protocol. During the 1 year data collection period (November 2005–October 2006), all deliveries with PPH were prospectively identified in each unit. Information on the patient9s characteristics, those of the pregnancy and delivery, and outcome data was collected from the chart of every delivery with PPH. Differences in outcomes between the intervention group and the control group were tested with a two-level logistic regression with a random intercept, to take into account the hierarchical structure of the data with women clustered in maternity units. Primary and secondary outcomes were estimated for each of the four trimesters of the 1-year-inclusion period. The effect of time was tested in the intervention and control groups separately, and the intervention effect on this temporal evolution was quantified. Results The mean rate of severe PPH was 1.64% (SD 0.80) in the intervention units and 1.65% (SD 0.96) in the control units; the difference was not significant. The intervention was associated with a higher rate of some recommended PPH management procedures: calling for help from senior staff (p=0.005), administration of sulprostone in severe PPH due to uterine atony (p=0.06), blood test within 60 min of diagnosis in severe PPH (p=0.09). The mean rate of severe PPH decreased between the first and third trimesters (1.79% (SD 1.21) and 1.52% (SD 0.87) respectively; p=0.07) in the intervention units, and was significantly lower in both the third and fourth trimesters than in the first trimester (1.60% (SD 1.05), 1.45% (SD 1.05) and 1.91% (SD1.44) respectively; p=0.01 and 0.03) in the control units. The trend of decrease with trimester of the rate of severe PPH was not significantly different between the two groups. Conclusion This educational intervention did not affect the rate of severe PPH, although it improved some practices. A parallel effect in the intervention units (through contamination by the intervention or external factors) may have contributed to the absence of a major difference between the two arms. Further research is needed on the role of organisational factors as well as individual components of the care recommended for PPH on the risk of severe PPH, for many of these are not evidence-based. Such evidence will help to focus future educational interventions on the most important aspects of care. Contexte, objectif L9hemorragie du postpartum (HPP) est l9une des causes majeures de mortalite maternelle et la cause principale de morbidite maternelle severe dans les pays developpes. Diminuer la prevalence de l9HPP severe constitue une priorite en obstetrique. La plupart de ces cas severes semblent associes a une prise en charge suboptimale. En reponse, des recommandations de pratique clinique relatives a l9HPP ont ete edictees, au niveau national et international. Cependant, l9existence de telles recommandations ne suffit pas pour obtenir leur traduction effective dans la pratique clinique, et il necessaire d9evaluer l9efficacite de strategies d9intervention specifiques dans ce but. Notre objectif etait d9evaluer l9efficacite d9un programme d9intervention multifacettes destine a favoriser l9integration dans la pratique clinique de recommandations de prise en charge de l9HPP, afin de diminuer l9incidence de l9HPP severe. Methodes Dans un essai randomise en cluster conduit dans 6 regions francaises, 106 maternites (representant 17% des maternites francaises et realisant 20% des accouchements du pays) ont ete assignees par tirage au sort au bras intervention -programme multifacette combinant une discussion des recommandations dans chaque maternite, l9utilisation de “reminders” et un audit clinique-, ou au bras reference -diffusion passive des recommandations. Le critere de jugement principal etait l9incidence de l9HPP severe, definie par la presence d9un au moins des criteres suivants: transfusion, embolisation, chirurgie, trasfert en reanimation, delta peripartum d9hemoglobine de 4g/dl ou plus, deces. Les criteres de jugements secondaires portaient sur la conformite des pratiques reelles de prise en charge de l9HPP aux principales etapes des recommandations. Tous les accouchements avec HPP ont ete identifies prospectivement pendant une annee (Novembre 2005–Octobre 2006) dans chaque maternite. Pour chacun de ces cas, l9information sur les caracteristiques de la femme, de sa grossesse, de son accouchement, et le deroulement del9HPP, etait collectee a partir du dossier obstetrical. Les differences entre les 2 bras pour les criteres de jugement ont ete testees en utilisant un modele de regression logistique a 2 niveaux prenant en compte la structure hierarchique des donnees et la correlation intra-maternite. Les criteres de jugement ont ete calcules pour chacun des quatre trimestres de l9annee d9inclusion. L9effet du temps a ete teste separement dans le bras intervention et dans le bras reference, et l9effet de l9intervention sur cette evolution temporelle a ete quantifie. Resultats L9incidence moyenne de l9HPP severe etait de 1.64% (SD 0.80) dans le bras intervention et 1.65% (SD 0.96) dans le bras reference; cette difference n9etait pas significative. Certaines pratiques etaient plus souvent conformes aux recommandations dans le bras intervention: appel d9un medecin senior(p=0.005); administration de sulprostone en cas d9HPP severe par atonie uterine (p=0.06), bilan biologique dans les 60 min en cas d9HPP severe(p=0.09). L9incidence moyenne de l9HPP severe est passee de 1.79% (SD1.21) au premier trimestre a 1.52% (SD 0.87) au troisieme trimestre dans les le bras intervention (p=0.07), et etait significativement plus basse aux 3eme et 4eme trimestres qu9au 1er trimestre (1.60% (SD 1.05), 1.45% (SD 1.05) et 1.91% (SD1.44) respectivement; p=0.01 et 0.03) dans le bras reference. La diminution de l9incidence de l9HPP severe au cours du temps n9etait pas differente entre les 2 groupes. Conclusion L9intervention n9a pas modifie l9incidence de l9HPP severe, bien qu9elle ait ameliore la conformite de certaines pratiques cliniques relatives a l9HPP. Un effet parallele dans les maternites du bras reference a pu contribuer a l9absence de difference majeure entre les bras. Des travaux ulterieurs sont necessaires pour preciser le role des facteurs organisationnels et des composantes specifiques de la prise en charge recommandee de l9HPP vis-a-vis du risque d9HPP severe, car la plupart ne reposent pas sur des preuves scientifiques solides. Ceci permettrait de cibler les interventions d’education sur les aspects les plus determinants des soins.

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Deneux-Tharaux Catherine

Papers

The challenge of defining women at low-risk for childbirth: analysis of peripartum severe acute maternal morbidity in women considered at low-risk according to French guidelines.

191 Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the pithagore6 cluster-randomised controlled trial