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Impact of Monitoring Quality Indicators in Maternity Departments on Mother and Infant Health

NCT01459978 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60000

Last updated 2018-03-02

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Rym BOULKEDID · Hopital Robert Debre, Clinical Epidemiology Unit

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459978 on ClinicalTrials.gov