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Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks
This study is currently recruiting participants.
Verified by Hospices Civils de Lyon, April 2007
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00344929
  Purpose

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
Post Partum Haemorrhage

Drug Information available for: Salicylic acid
U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study
Official Title: Severe Post Partum Haemorrhage (PPH): A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks

Further study details as provided by Hospices Civils de Lyon:

Estimated Enrollment: 6500
Study Start Date: November 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For maternity units All maternity units belonging to one of the six perinatal networks of the study are eligible.

For women All women delivering at a gestational age greater than 22 weeks, in one of the participating maternity unit during the study period, will be eligible.

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344929

Contacts
Contact: Cyrille COLIN, MD 33 472 11 57 71 cyrille.colin@chu-lyon.fr

Locations
France
Cyrille Colin Recruiting
Lyon, France, 69003
Contact: Cyrille Colin, MD     33 472 11 57 71     cyrille.colin@chu-lyon.fr    
Principal Investigator: René-Charles RUDIGOZ, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: René-Charles RUDIGOZ, MD Hospices Civils de Lyon
  More Information

Study ID Numbers: PITHAGORE 6
Study First Received: June 26, 2006
Last Updated: April 26, 2007
ClinicalTrials.gov Identifier: NCT00344929  
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Postpartum Hemorrhage
Pregnancy Complications
Uterine Hemorrhage
Puerperal Disorders
Obstetric Labor Complications
Salicylic Acid
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on February 06, 2009