Impact of Monitoring Quality Indicators in Maternity Departments on Mother and Infant Health (MATICUS)
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|ClinicalTrials.gov Identifier: NCT01459978|
Recruitment Status : Recruiting
First Posted : October 26, 2011
Last Update Posted : October 10, 2016
Hypothesis: Continuously monitor quality indicators with a specific method (CUSUM: Cumulative Sum) will increase the awareness of health care staff in maternity and permit rapid detection of a small dip in performance in order to enable prompt investigations and corrective measures when necessary , which decrease maternal and neonatal mortality and morbidity.
Objective: To assess the impact of Cumulative Sum (CUSUM) charts used as a maternity dashboard to decreases maternal and neonatal mortality and morbidity.
Design: Step-wedge cluster-randomized trial with prospective analyses of collected data.
Setting: ten Maternity departments in France. Population: Data from 60 000 women and infants could be collected over 2 year's period.
Method: Cumulative sum (CUSUM) charts were used to monitor the rate of quality indicators previously selected by Delphi method.
Main Outcome Measures: Composite outcome that considers multiple clinical events : mortality, adverse outcomes for women and newborn.
|Condition or disease||Intervention/treatment|
|Obstetric; Injury Injury||Other: CUmulative SUM (CUSUM) Chart|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||60000 participants|
|Official Title:||Impact of Using Cumulative SUM (CUSUM) Control Chart in Maternity Department on Mother and Infant Health: a Cluster Randomized Trial|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Early CUSUM result group
Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity.
Phase 2: results of the CUmulative SUM (CUSUM) will be provided for a period of 12 months (Early CUSUM result group), Phase 3: maternity will continue to receive the results of the CUmulative SUM (CUSUM) for a period of 12 months,
Other: CUmulative SUM (CUSUM) Chart
Intervention is described as follows:
Step 1: Implementation of the CUmulative SUM (CUSUM)control chart using available medical data Step 2: Submission of monthly results to the coordinator of each participating center (if CUmulative SUM (CUSUM) results period).
Step 3: When an alarm is generated, the steering committee will meet with maternity staff to find the causes of these alerts and propose
CUSUM result Delayed group
Phase 1: 3 months testing and observation period. During this phase, rates of each quality indicator selected will be collected to adjust the acceptable and unacceptable rate set by practitioners of each maternity Phase 2: the results of CUmulative SUM (CUSUM) will not be shared. Phase 3: group receive CUmulative SUM (CUSUM) result (CUSUM result Delayed group) during the same period 12 months
- Indicator of mother health [ Time Frame: After 24 months ]
is a composite outcome taking into account :
- - mortality,
- complications of pre-eclampsia
- Hemolysis ,Elevated Liver enzymes, Low Platelet syndrome (HELLP):
- Disseminated intravascular coagulation (DIC)
- retro-placental hematoma,
- - postpartum hemorrhage
- - severe bleeding
- Pulmonary embolism
- - postpartum infections
- - severe perineal injury
- - need of intensive care transfer for women
- Indicator of newborn health [ Time Frame: After 24 months ]
is a composite outcome of mortality and morbidity. Morbidities taken into account several clinical events:
- - postnatal deaths (8days 1 month)
- - prematurity: medical or spontaneous
- - low birth weight (weight less than 2 kg at 37 weeks)
- - maternal-fetal infection: occurring in the first hours of life (germs: B streptococcus, E. coli, streptococcus, non-B)
- - transfer resuscitation term
- - chromosomal abnormalities with absence of screening
- - malformations without screening and diagnostic
- Women satisfaction [ Time Frame: After 12 and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459978
|Contact: Rym BOULKEDID, Phd||0033 1 40 03 23 firstname.lastname@example.org|
|Contact: Olivier Sibony, Professor||0033 1 40 03 47 email@example.com|
|Paris, France, 75019|
|Contact: Rym Boulkedid +33140032393 firstname.lastname@example.org|
|Robert Debré Hospital||Not yet recruiting|
|Paris, France, 75019|
|Contact: Rym BOULKEDID +33 (0) 1 40 03 23 46 email@example.com|
|Contact: Olivier Sibony +33 (0) 1 40 03 47 89 firstname.lastname@example.org|
|Principal Investigator: Rym BOULKEDID, Phd|
|Study Chair:||Rym BOULKEDID||Hopital Robert Debre, Clinical Epidemiology Unit|