Condition category
Neonatal Diseases
Date applied
04/12/2007
Date assigned
05/12/2007
Last edited
31/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pierre Fournier

ORCID ID

Contact details

Université de Montréal
3875 St Urbain
Montreal
Quebec
H2W 1V1
Canada
+1 514 890 8000 ext. 15926
Pierre.fournier@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-82503

Study information

Scientific title

Quality of care, risk management and obstetrical techniques in developing countries (QUalité des soins, gestion du RIsque et TEchniques obstétricales dans les pays en développement [QUARITE])

Acronym

QUARITE

Study hypothesis

Principal hypothesis:
The program ALARM international reduces by 30% the global case fatality rate, measured in the hospitals during the post-intervention period, compared to the control group.

Secondary hypotheses:
1. Reduction of stillbirth and early neonatal mortality
2. Improvement in the quality of care by a better utilisation of local resources and changes in professional practices
3. Increase in health workers satisfaction

Ethics approval

Ethics approval received from:
1. Research Ethic Committee, Saint Justine's Hospital (Le comité d'éthique de la recherche, l'Hôpital Sainte-Justine), Montréal, Québec (Canada) on the 20th November 2006 (ref: # 2425)
2. Ministry of Health and Preventive Medicine, Health Directorate, Republic of Senegal (Ministère de la santé et de la prévention médicale, Direction de la santé, République du Sénégal) on the 10th May 2007 (ref: # 0869 MSPM/DS/DER)
3. National Ethics Committee for health and life sciences, Ministry of Health, Republic of Mali (Comité national d'éthique pour la santé et les sciences la vie [CNESS], Ministère de la santé, République du Mali) on the 18th June 2007 (ref: # 034/MS-SG-CNESS)

Study design

Multicentre international two arm randomised cluster trial of educational nature

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Maternal mortality/neonatal mortality

Intervention

Training of opinion leaders to optimal professional practices and to maternal deaths audits (training of trainers):
1. Training of obstetric team in hospital
2. Implementation of audit in hospitals
3. External facilitators visits
4. Recertification of opinion of the leaders

Joint contact for scientific queries (with Pierre Fournier - details given below):
Alexandre Dumont
Université de Montréal
Tel: +221 (0)33 820 78 16
Email: alex.dumont@orange.sn

Contacts for public queries:
Dr Idrissa Diop
HYGEA Senegal
Email: hygea@sentoo.sn

Dr Mamadou Konate
CAREF Mali
Email: Mamadou.konate@caref.org

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Global case fatality rate measured in the hospitals in post intervention period (year 4).

Secondary outcome measures

1. Distribution of principal causes of maternal morbidity and mortality
2. Case fatality rates for obstetric complications
3. Mortinatality rate in hospital
4. Early neonatal mortality in hospital
5. Obstetric interventions rate
6. Emergency obstetric care availability score
7. Human resources satisfaction score

Overall trial start date

01/03/2007

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

At the hospital level:
1. Public referral hospital (district, department, regional or national)
2. Availability of surgical theatre
3. Annual number of deliveries greater than 800
4. Consent form signed by the maternity director and hospital director to participate in the study

At the individual level:
1. Women admitted for delivery including those referred to the hospital or who died in the transport to hospital
2. Pregnant women from 12 to 45 years old

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

174 688 women nested in 44 hospitals

Participant exclusion criteria

At the hospital level:
1. Private hospital
2. Public hospital with less than 800 deliveries per year
3. Surgical theatre not operational
4. Hospitals where the maternal deaths audit were already implemented
5. No signed consent form directors of maternity and hospital

At the individual level:
1. Women admitted not pregnant
2. Women admitted for complications during the first quarter of pregnancy (miscarriage, ectopic pregnancy)
3. Women admitted after 42 days after the end of pregnancy
4. Late maternal deaths or deaths from accidental causes

Recruitment start date

01/03/2007

Recruitment end date

01/11/2011

Locations

Countries of recruitment

Canada, Mali, Senegal

Trial participating centre

Université de Montréal
Quebec
H2W 1V1
Canada

Sponsor information

Organisation

Sainte-Justine Hospital Research Centre (CHU Sainte-Justine) (Canada)

Sponsor details

c/o Sylvie Cossette
3175 Cote Sainte Catherine
Montreal
Quebec
H3T 1C5
Canada
+1 514 345 4931 ext. 5657
sylvie.cossette@recherche-ste-justine.qc.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 (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-82503)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19765280
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23106962
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23351269
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23721752

Publication citations

  1. Results

    Dumont A, Fournier P, Fraser W, Haddad S, Traore M, Diop I, Gueye M, Gaye A, Couturier F, Pasquier JC, Beaudoin F, Lalonde A, Hatem M, Abrahamowicz M, QUARITE (quality of care, risk management and technology in obstetrics): a cluster-randomized trial of a multifaceted intervention to improve emergency obstetric care in Senegal and Mali., Trials, 2009, 10, 85, doi: 10.1186/1745-6215-10-85.

  2. Results

    Pirkle CM, Dumont A, Traore M, Zunzunegui MV, Validity and reliability of criterion based clinical audit to assess obstetrical quality of care in West Africa., BMC Pregnancy Childbirth, 2012, 12, 118, doi: 10.1186/1471-2393-12-118.

  3. Results

    Pirkle CM, Dumont A, Traoré M, Zunzunegui MV, , Effect of a facility-based multifaceted intervention on the quality of obstetrical care: a cluster randomized controlled trial in Mali and Senegal., BMC Pregnancy Childbirth, 2013, 13, 24, doi: 10.1186/1471-2393-13-24.

  4. Results

    Dumont A, Fournier P, Abrahamowicz M, Traoré M, Haddad S, Fraser WD, , Quality of care, risk management, and technology in obstetrics to reduce hospital-based maternal mortality in Senegal and Mali (QUARITE): a cluster-randomised trial., Lancet, 2013, 382, 9887, 146-157, doi: 10.1016/S0140-6736(13)60593-0.

Additional files

Editorial Notes