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Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial

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Please cite this paper as: Deneux-Tharaux C, Dupont C, Colin C, Rabilloud M, Touzet S, Lansac J, Harvey T, Tessier V, Chauleur C, Pennehouat G, Morin X, Bouvier-Colle M, Rudigoz R. Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial. BJOG 2010;117:1278–1287. Objective 

Decreasing the prevalence of severe postpartum haemorrhages (PPH) is a major obstetrical challenge. These are often considered to be associated with substandard initial care. Strategies to increase the appropriateness of early management of PPH must be assessed. We tested the hypothesis that a multifaceted intervention aimed at increasing the translation into practice of a protocol for early management of PPH, would reduce the incidence of severe PPH. Design 

Cluster-randomised trial. Population 

106 maternity units in six French regions. Methods 

Maternity units were randomly assigned to receive the intervention, or to have the protocol passively disseminated. The intervention combined outreach visits to discuss the protocol in each local context, reminders, and peer reviews of severe incidents, and was implemented in each maternity hospital by a team pairing an obstetrician and a midwife. Main outcome measures 

The primary outcome was the incidence of severe PPH, defined as a composite of one or more of: transfusion, embolisation, surgical procedure, transfer to intensive care, peripartum haemoglobin decrease of 4 g/dl or more, death. The main secondary outcomes were PPH management practices. Results 

The mean rate of severe PPH was 1.64% (SD 0.80) in the intervention units and 1.65% (SD 0.96) in control units; difference not significant. Some elements of PPH management were applied more frequently in intervention units—help from senior staff (P = 0.005), or tended to - second-line pharmacological treatment (P = 0.06), timely blood test (P = 0.09). Conclusion 

This educational intervention did not affect the rate of severe PPH as compared with control units, although it improved some practices.
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Keywords: Clinical practices; cluster-randomised trial; educational intervention; maternal health; postpartum haemorrhage

Document Type: Research Article

Affiliations: 1: INSERM, UMR S953, UPMC, Epidemiological Research Unit on Perinatal Health and Women’s and Children’s Health, Paris, France 2: Aurore Perinatal Network, Hospices Civils de Lyon, Lyon 1 University, Lyon, France 3: Department of Medical Information and Health Care Evaluation, Hospices Civils de Lyon, Lyon 1 University, Lyon, France 4: Hospices Civils de Lyon, Service de Biostatistiques, Lyon; CNRS UMR 5558, Universit√© de Lyon, France 5: PerinatCentre Perinatal Network, Tours University Hospital, France 6: Port Royal St Vincent de Paul Perinatal Network, Paris, France 7: Loire Nord Ardeche Perinatal Network, Saint Etienne University Hospital, France 8: 2 Savoie Perinatal Network, Chambery Hospital, France 9: Alpes Isere Perinatal Network, Grenoble University Hospital, France

Publication date: 2010-09-01

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