Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks
|ClinicalTrials.gov Identifier: NCT00344929|
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was: Recruiting
First Posted : June 27, 2006
Last Update Posted : April 27, 2007
Hypothesis A “multifaceted” intervention program aimed at increasing the responsiveness of care givers, the adequacy of care provided, and the efficacy of organisation of care, in presence of abnormal blood loss in the immediate post partum has more impact on the incidence of severe PPH and on the costs of care than the current methods of dissemination of clinical practice guidelines.
Intervention Intervention group. The intervention includes three components: (1) outreach visits with local presentation of evidence-based clinical practice guidelines for management of PPH, and discussion of their applicability in the context of local organisation; (2) during these educational visits, reminders - check list, “PPH emergency case” containing appropriate materials – to be used in case of PPH, will be proposed; (3) finally, cases of severe PPH will be reviewed during peer review sessions organized in each participating unit, to help identifying weaknesses in care provided, and needs for improvement.
Control group. The proposed guidelines for management of PPH will be disseminated through the participating perinatal networks; then each unit will be free to implement them at its own convenience.
Randomisation procedure The trial follows a cluster randomised trial design. Randomisation of maternity units will be stratified by region, status (public versus private) and size (annual number of deliveries). The stratified design will guarantee the comparability of the two arms of the trial at baseline.
Outcome measures The primary outcome is the incidence of severe PPH (number of severe PPH to number of deliveries). A severe PPH is defined as a PPH that was associated with one or more of the following: peripartum haemoglobin drop greater than 4g/dl, blood transfusion, arterial embolisation, surgical procedures such as hysterectomy or arterial ligation, transfer of the mother to intensive care unit, maternal death.
Secondary outcomes include the cost of care and the cost/efficacy ratio, and the incidence of adverse effects of uterotonic drugs.
|Condition or disease|
|Post Partum Haemorrhage|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||6500 participants|
|Observational Model:||Defined Population|
|Official Title:||Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks|
|Study Start Date :||November 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344929
|Contact: Cyrille COLIN, MD||33 472 11 57 firstname.lastname@example.org|
|Lyon, France, 69003|
|Contact: Cyrille Colin, MD 33 472 11 57 71 email@example.com|
|Principal Investigator: René-Charles RUDIGOZ, MD|
|Principal Investigator:||René-Charles RUDIGOZ, MD||Hospices Civils de Lyon|