Quality of care, obstetrical risk management and type of deliveries in Quebec (qualité des soins, gestion du risque obstétrical et du mode d'accouchement au Québec)

ISRCTN	ISRCTN95086407
DOI	https://doi.org/10.1186/ISRCTN95086407
Secondary identifying numbers	MCT-84657

Submission date: 23/10/2007
Registration date: 23/10/2007
Last edited: 24/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nils Chaillet
Scientific

CHU Sainte-Justine
3175 Chemin de la Côte Sainte-Catherine
Bureau 4981
Montreal
Quebec
H3T 1C5
Canada

Phone	+1 (0)514 345 4931 ext. 4373
Email	nilsc@wanadoo.fr

Study information

Study design	Multicentre two-arm randomised cluster trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Information in English is not yet available in web format, please use the contact details to request a patient information sheet
Scientific title	Quality of care, obstetrical risk management and type of deliveries in Quebec: a multicentre, two arm, randomised cluster trial
Study acronym	QUARISMA
Study objectives	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(s)	Le comite d'ethique de la rechereche du CHU Ste-Justine, Montreal, QC (Canada), 15/10/2007, ref: #2604
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2008
Completion date	31/10/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	32 hospitals
Key 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
Key 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
Date of first enrolment	01/04/2008
Date of final enrolment	31/10/2011

Locations

Countries of recruitment

Canada

Study participating centre

CHU Sainte-Justine

Quebec
H3T 1C5
Canada

Sponsor information

Sainte-Justine Hospital Research Center (Centre de recherche du CHU Sainte-Justine) (Canada)
Hospital/treatment centre

3175 Chemin Côte Ste-Catherine
Montreal
Quebec
H3T 1C5
Canada

Phone	+1 (0)514 345 4931 ext. 5657
Email	sylvie.cossette.inf@umontreal.ca
Website	http://www.recherche-sainte-justine.qc.ca/en/
"ROR"	https://ror.org/01gv74p78

Funders

Funder type

Research organisation

Canadian Institutes of Health Research
Government organisation / National government

Alternative name(s): Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	30/04/2015		Yes	No
Results article	cost-effectiveness results	22/05/2017		Yes	No

Editorial Notes

24/05/2017: Publication reference added.

18/03/2009: The overall trial start and end dates were updated; the initial trial dates at the time of registration were 01/01/2008 and 30/06/2011, respectively.