Contact information
Type
Scientific
Primary contact
Dr Nils Chaillet
ORCID ID
Contact details
CHU Sainte-Justine
3175 Chemin de la Côte Sainte-Catherine
Bureau 4981
Montreal
Quebec
H3T 1C5
Canada
+1 (0)514 345 4931 ext. 4373
nilsc@wanadoo.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-84657
Study information
Scientific title
Quality of care, obstetrical risk management and type of deliveries in Quebec: a multicentre, two arm, randomised cluster trial
Acronym
QUARISMA
Study hypothesis
Primary hypothesis:
The QUARISMA program will result in a 20% reduction in the rate of caesarean section (CS) among the hospitals following the intervention compared to control hospitals.
Secondary hypotheses:
This program will result in:
1. A reduction in materno-foetal morbidity, including a reduction in severe morbidity among low risk patients.
2. No augmentation in materno-foetal morbidity among high risk patients.
Ethics approval
Le comite d'ethique de la rechereche du CHU Ste-Justine, Montreal, QC (Canada), 15/10/2007, ref: #2604
Study design
Multicentre two-arm randomised cluster trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Information in English is not yet available in web format, please use the contact details to request a patient information sheet
Condition
Caesarean section rate
Intervention
Audit Group Hospitals:
1. Society of Obstetricians and Gynaecologists of Canada provide training to health professionals (2 days at the year 2 and 1 day at the year 3)
2. Four self audit cycles with supervision by research team (3 months each), facilitated by a local opinion leader, starting at the sixth month of the second year for one year
3. Four other self audit cycles without supervision (3 months each) for another year
Control Group Hospitals:
Usual care.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Caesarean section rate (total number of CS/total number of deliveries): data is collected every day from womens' clinical files during the 3.5 years of the program in the 32 hospitals (16 control and 16 interventions), to compare caesarean section rates in the intervention group with the rate in the control group at the end of the intervention period (year 3) and at the end of the follow-up period (year 4 or post intervention period).
Secondary outcome measures
Measured at the end of the intervention period (year 3) and at the end of the follow-up period (year 4 or post intervention period):
1. Caesarean section rate stratified by indications
2. Caesarean section rate stratified by type of CS (primary or repeat) and by the risk level of the delivery (high or low risk)
3. Vaginal birth after caesarean section rate
4. Obstetrical intervention rate
5. Maternal and neonatal morbidity
Overall trial start date
01/04/2008
Overall trial end date
31/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Hospital level:
1. Public hospitals with functional surgical rooms
2. More than 300 deliveries per year
3. A caesarean rate greater than or equal to 17%
4. Written agreement to participate in the study from the directors of maternity services and professional services
Woman level (data collection):
5. Women carrying a viable foetus more than 500 grams during the course of the study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
32 hospitals
Participant exclusion criteria
Hospital level:
1. Public hospitals with an existing intervention for reducing caesarean section
Woman level (data collection):
2. Women that give birth or abort before 24 weeks of gestation
Recruitment start date
01/04/2008
Recruitment end date
31/10/2011
Locations
Countries of recruitment
Canada
Trial participating centre
CHU Sainte-Justine
Quebec
H3T 1C5
Canada
Sponsor information
Organisation
Sainte-Justine Hospital Research Center (Centre de recherche du CHU Sainte-Justine) (Canada)
Sponsor details
3175 Chemin Côte Ste-Catherine
Montreal
Quebec
H3T 1C5
Canada
+1 (0)514 345 4931 ext. 5657
sylvie.cossette.inf@umontreal.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25923551
2017 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/28528578