Plain English Summary
Background and study aims
Maternal and perinatal mortality (death of mother/newborn baby) are major problems for which progress in sub-Saharan Africa has been inadequate, although childbirth services are available even in the poorest countries. Reducing these deaths is the aim of two of the main Millennium Development Goals. There have been many initiatives to remedy this situation, such as the Advances in Labour and Risk Management (ALARM) International Program, whose purpose is to improve the quality of obstetric services in low-income countries. However, few interventions have been tested in this context with rigorous methods for analysing effectiveness in terms of health outcomes. The aim of this study is to assess the effectiveness of the ALARM International Program (AIP) at reducing maternal mortality in referral hospitals in Senegal and Mali.
Who can participate?
Pregnant women from 12 to 45 years old who deliver in one of the participating hospitals
What does the study involve?
Participating hospitals are randomly allocated to the intervention group or the control group. The intervention group hospitals receive a combination of two approaches aimed at improving the performance of health personnel: educational outreach visits and the introduction of facility-based maternal death reviews. The intervention lasts 2 years. The control group hospitals do not receive the intervention. Maternal mortality rates, resource availability, quality of care, maternal morbidity (illness), perinatal mortality, and health personnel satisfaction are compared between the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Université de Montréal (Canada)
When is the study starting and how long is it expected to run for?
March 2007 to November 2011
Who is funding the study?
Canadian Institutes of Health Research (CIHR) (Canada)
Who is the main contact?
1. Dr Alexandre Dumont (scientific)
alexandre.dumont@ird.fr
2. Dr Pierre Fournier (scientific)
pierre.fournier@umontreal.ca
3. Dr Idrissa Diop (public)
hygea@sentoo.sn
4. Dr Mamadou Konate (public)
Mamadou.konate@caref.org
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 (0)514 890 8000 ext. 15926
Pierre.fournier@umontreal.ca
Type
Scientific
Additional contact
Dr Alexandre Dumont
ORCID ID
Contact details
Université de Montréal
Montréal
-
Canada
+221 (0)33 820 78 16
alex.dumont@orange.sn
Type
Public
Additional contact
Dr Idrissa Diop
ORCID ID
Contact details
HYGEA Senegal
-
-
Senegal
-
hygea@sentoo.sn
Type
Public
Additional contact
Dr Mamadou Konate
ORCID ID
Contact details
CAREF Mali
-
-
Mali
-
Mamadou.konate@caref.org
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
1. Research Ethic Committee, Saint Justine's Hospital (Le comité d'éthique de la recherche, l'Hôpital Sainte-Justine), Montréal, Québec (Canada), 20/11/2006, 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), 10/05/2007, 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), 18/06/2007, ref: # 034/MS-SG-CNESS
Study design
Multicentre international two-arm randomised cluster trial of educational nature
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a 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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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 (if study stopped)
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 (0)514 345 4931 ext. 5657
sylvie.cossette@recherche-ste-justine.qc.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (ref: MCT-82503)
Alternative name(s)
Instituts de Recherche en Santé du Canada, CIHR
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19765280
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23106962
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23351269
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23721752
Publication citations
-
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.
-
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.
-
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.
-
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.