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Maternal mortality and obstetric care
DOI 10.1186/ISRCTN46950658
ClinicalTrials.gov identifier
EudraCT number
Public title Maternal mortality and obstetric care
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])
Serial number at source MCT-82503
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
Lay summary Lay summary under review 3
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
Countries of recruitment Canada, Mali, Senegal
Disease/condition/study domain Maternal mortality/neonatal mortality
Participants - 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
Participants - 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
Anticipated start date 01/03/2007
Anticipated end date 01/11/2011
Status of trial Completed
Patient information material
Target number of participants 174 688 women nested in 44 hospitals
Interventions 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
Email: Mamadou.konate@caref.org
Primary outcome measure(s) Global case fatality rate measured in the hospitals in post intervention period (year 4).
Secondary outcome measure(s) 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
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: MCT-82503)
Trial website
Publications 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
Contact name Dr  Pierre  Fournier
  Address Université de Montréal
3875 St Urbain
  City/town Quebec
  Zip/Postcode H2W 1V1
  Country Canada
  Tel +1 514 890 8000 ext. 15926
  Fax +1 514 412 7108
  Email Pierre.fournier@umontreal.ca
Sponsor Sainte-Justine Hospital Research Centre (CHU Sainte-Justine) (Canada)
  Address c/o Sylvie Cossette
3175 Cote Sainte Catherine
  City/town Quebec
  Zip/Postcode H3T 1C5
  Country Canada
  Tel +1 514 345 4931 ext. 5657
  Fax +1 514 345 7738
  Email sylvie.cossette@recherche-ste-justine.qc.ca
  Sponsor website: http://www.recherche-sainte-justine.qc.ca/en
Date applied 04/12/2007
Last edited 31/07/2013
Date ISRCTN assigned 05/12/2007
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