Condition category
Neonatal Diseases
Date applied
04/12/2007
Date assigned
05/12/2007
Last edited
25/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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 (0)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 (ref: MCT-82503)

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

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

  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

25/05/2017: Plain English summary added.