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Randomized Controlled Trial
. 2010 Sep;117(10):1278-87.
doi: 10.1111/j.1471-0528.2010.02648.x. Epub 2010 Jun 24.

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

C Deneux-Tharaux  1 , C Dupont, C Colin, M Rabilloud, S Touzet, J Lansac, T Harvey, V Tessier, C Chauleur, G Pennehouat, X Morin, M H Bouvier-Colle, R Rudigoz
Affiliations
Randomized Controlled Trial

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

C Deneux-Tharaux et al. BJOG. 2010 Sep.

Abstract

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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Figures

Figure 1
Figure 1
Flow diagram
Figure 2
Figure 2. Mean rate of severe PPH and of all PPH by allocation group and time periods of trial (T1 to T4)
1 data on number of deliveries by trimester not available in one unit * p<0.05 for test of difference from mean rate in first trimester.
See this image and copyright information in PMC

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