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


METHODS
Cluster-randomised trial.


METHODS
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.


METHODS
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).


CONCLUSIONS
This educational intervention did not affect the rate of severe PPH as compared with control units, although it improved some practices.
Deneux-Tharaux
C
C
INSERM, UMR S953, UPMC, Epidemiological Research Unit on Perinatal Health and Women's and Children's Health, Paris, France. catherine.deneux-tharaux@inserm.fr
Dupont
C
C
Colin
C
C
Rabilloud
M
M
Touzet
S
S
Lansac
J
J
Harvey
T
T
Tessier
V
V
Chauleur
C
C
Pennehouat
G
G
Morin
X
X
Bouvier-Colle
M H
MH
Rudigoz
R
R
D002985:Clinical Protocols; D016000:Cluster Analysis; D004502:Education, Medical, Continuing; D005260:Female; D005602:France; D006771:Hospitals, Maternity; D006801:Humans; D015994:Incidence; D008880:Midwifery / Q000193:education; D009774:Obstetrics / Q000193:education; D010348:Patient Care Team; D006473:Postpartum Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D011247:Pregnancy; D011364:Professional Practice / Q000592:standards*; D018401:Sample Size; D016896:Treatment Outcome