Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344929
Status:
UNKNOWN
Last Update Posted:
2007-04-27
First Post:
2006-06-26
Brief Title:
Severe Post Partum Haemorrhage PPH A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Severe Post Partum Haemorrhage PPH A Randomized Trial on Transversal Intervention in 6 French Perinatal Networks
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 4gdl 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 costefficacy ratio and the incidence of adverse effects of uterotonic drugs
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 4gdl 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 costefficacy ratio and the incidence of adverse effects of uterotonic drugs
Detailed Description:
Background Post partum haemorrhage PPH is estimated to occur in 5 to 10 of deliveries In France this represents about 39 000 to 78 000 cases yearly among which 10 to 20 are life threatening events for the mothers Moreover PPH remains the leading cause of maternal mortality in France contributing to a greater proportion of maternal deaths than in other comparable European countries
According to the National Committee on Maternal Mortality more than 80 of deaths due to PPH are avoidable deaths involving unrecognised diagnosis delay in providing care and underestimation of the severity of blood spoliation These factors suggest weaknesses in the capacity for providing adequate care in presence of PPH and they seem to be related to the organisation of care inside the maternity units
On the other hand although some specific clinical interventions have proved efficient in decreasing postpartum blood loss thus resulting in recent national and international recommendations for management of PPH integration of these guidelines into clinical practice still is to be achieved preliminary unpublished results from a survey conducted in maternity units in France
Available literature related to various health issues shows that the use of enhanced methods for dissemination of clinical practice guidelines can improve the translation of these guidelines into practice Therefore an intervention combining several enhanced dissemination methods may help improving the actual management of PPH cases
The impact of the proposed intervention will be evaluated through a randomised trial The target of the intervention is in a given maternity unit the entire group of health professionals involved in delivery care Therefore the unit of randomisation will be the maternity unit
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 4gdl 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 costefficacy ratio and the incidence of adverse effects of uterotonic drugs
Number of patients required Estimation of the intracluster correlation coefficient Since no estimation of this parameter was available in the literature we based our estimation on results of an unpublished survey providing data on declared incidence of severe PPH in maternity units Based on these results the intracluster correlation coefficient is estimated to be 0006
Assuming an incidence of 1 for the primary outcome and in order to detect a decrease to 06 40 relative decrease with 80 power and 5 risk and taking into account the average number of deliveries per unit and the estimated intracluster correlation the required sample size is 58 945 deliveries by group and 117890 in total
The 6 participating perinatal networks include 133 maternity units performing 133 000 deliveries annually
Eligibility 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
Trial process Recruitment All maternity units pertaining to one of the 6 perinatal networks will be invited to participate The trial protocol will be presented to obstetricians anaesthetists and midwives
Consent A written consent will be obtained from the head of the obstetrics department and from the administrative director of each unit
Intervention In each participating perinatal network a team pairing an obstetrician and a midwife will be in charge of the intervention program
Start date March 2005 Expected complete date December 2007
Data collection Baseline data The comparability of the two arms of the trial will be evaluated through data collected at the maternity unit level including characteristics and resources of the unit and characteristics of the women delivering
Post-intervention data Evaluation of the impact of the intervention on clinical practice related to PPH management will be based on individual data
What Detailed information on components of care provided during labour delivery and immediate post partum related to prevention and management of PPH collected in individual cases of PPH
When collected Data collection will begin 3 months after the outreach visits and will include all incident cases of PPH during one year
How and by who Cases of PPH will be identified prospectively according to the following definition1 for a vaginal delivery PPH is defined as an abnormal bleeding diagnosed within the 24 hours postpartum which requires uterine revision or manual delivery of placenta and or resulting from vaginal or cervical tears including haemorrhagic episiotomy for a C section delivery PPH is defined as an abnormal bleeding diagnosed by the team in charge or 2 a peripartum haemoglobin drop greater than 2grdl
PPH cases will be identified by the care providers and notified to the trial research assistant who will collect individual information from obstetrical records
Outcome data Evaluation of the impact of the intervention on the incidence of severe PPH
What Incident cases of severe PPH see definition above will be identified as a subgroup of incident cases of PPH
When collected Data collection will begin 3 months after the outreach visits and will include all incident cases of severe PPH during one year
How and by who See above
According to the National Committee on Maternal Mortality more than 80 of deaths due to PPH are avoidable deaths involving unrecognised diagnosis delay in providing care and underestimation of the severity of blood spoliation These factors suggest weaknesses in the capacity for providing adequate care in presence of PPH and they seem to be related to the organisation of care inside the maternity units
On the other hand although some specific clinical interventions have proved efficient in decreasing postpartum blood loss thus resulting in recent national and international recommendations for management of PPH integration of these guidelines into clinical practice still is to be achieved preliminary unpublished results from a survey conducted in maternity units in France
Available literature related to various health issues shows that the use of enhanced methods for dissemination of clinical practice guidelines can improve the translation of these guidelines into practice Therefore an intervention combining several enhanced dissemination methods may help improving the actual management of PPH cases
The impact of the proposed intervention will be evaluated through a randomised trial The target of the intervention is in a given maternity unit the entire group of health professionals involved in delivery care Therefore the unit of randomisation will be the maternity unit
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 4gdl 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 costefficacy ratio and the incidence of adverse effects of uterotonic drugs
Number of patients required Estimation of the intracluster correlation coefficient Since no estimation of this parameter was available in the literature we based our estimation on results of an unpublished survey providing data on declared incidence of severe PPH in maternity units Based on these results the intracluster correlation coefficient is estimated to be 0006
Assuming an incidence of 1 for the primary outcome and in order to detect a decrease to 06 40 relative decrease with 80 power and 5 risk and taking into account the average number of deliveries per unit and the estimated intracluster correlation the required sample size is 58 945 deliveries by group and 117890 in total
The 6 participating perinatal networks include 133 maternity units performing 133 000 deliveries annually
Eligibility 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
Trial process Recruitment All maternity units pertaining to one of the 6 perinatal networks will be invited to participate The trial protocol will be presented to obstetricians anaesthetists and midwives
Consent A written consent will be obtained from the head of the obstetrics department and from the administrative director of each unit
Intervention In each participating perinatal network a team pairing an obstetrician and a midwife will be in charge of the intervention program
Start date March 2005 Expected complete date December 2007
Data collection Baseline data The comparability of the two arms of the trial will be evaluated through data collected at the maternity unit level including characteristics and resources of the unit and characteristics of the women delivering
Post-intervention data Evaluation of the impact of the intervention on clinical practice related to PPH management will be based on individual data
What Detailed information on components of care provided during labour delivery and immediate post partum related to prevention and management of PPH collected in individual cases of PPH
When collected Data collection will begin 3 months after the outreach visits and will include all incident cases of PPH during one year
How and by who Cases of PPH will be identified prospectively according to the following definition1 for a vaginal delivery PPH is defined as an abnormal bleeding diagnosed within the 24 hours postpartum which requires uterine revision or manual delivery of placenta and or resulting from vaginal or cervical tears including haemorrhagic episiotomy for a C section delivery PPH is defined as an abnormal bleeding diagnosed by the team in charge or 2 a peripartum haemoglobin drop greater than 2grdl
PPH cases will be identified by the care providers and notified to the trial research assistant who will collect individual information from obstetrical records
Outcome data Evaluation of the impact of the intervention on the incidence of severe PPH
What Incident cases of severe PPH see definition above will be identified as a subgroup of incident cases of PPH
When collected Data collection will begin 3 months after the outreach visits and will include all incident cases of severe PPH during one year
How and by who See above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None