Condition category
Pregnancy and Childbirth
Date applied
23/10/2007
Date assigned
23/10/2007
Last edited
30/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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, and
2. No augmentation in materno-foetal morbidity among high risk patients

Please note that as of 18/03/2009 the overall trial start and end dates in this record were amended; the initial trial dates at the time of registration were:
Initial overall trial start date: 01/01/2008
Initial overall trial end date: 30/06/2011

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 below 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

http://www.recherche-sainte-justine.qc.ca/en/

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

Publication citations

Additional files

Editorial Notes