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 |
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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
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 |
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nilsc@wanadoo.fr |
Study information
Study design | Multicentre two-arm randomised cluster trial |
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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 |
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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
H3T 1C5
Canada
Sponsor information
Sainte-Justine Hospital Research Center (Centre de recherche du CHU Sainte-Justine) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3175 Chemin Côte Ste-Catherine
Montreal
Quebec
H3T 1C5
Canada
Phone | +1 (0)514 345 4931 ext. 5657 |
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sylvie.cossette.inf@umontreal.ca | |
Website | http://www.recherche-sainte-justine.qc.ca/en/ |
https://ror.org/01gv74p78 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research
Government organisation / National government
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 | |
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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.