Maternal mortality and obstetric care
| ISRCTN | ISRCTN46950658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46950658 |
| Secondary identifying numbers | MCT-82503 |
- Submission date
- 04/12/2007
- Registration date
- 05/12/2007
- Last edited
- 25/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Université de Montréal
3875 St Urbain
Montreal
Quebec
H2W 1V1
Canada
| Phone | +1 (0)514 890 8000 ext. 15926 |
|---|---|
| Pierre.fournier@umontreal.ca |
Scientific
Université de Montréal
Montréal
-
Canada
| Phone | +221 (0)33 820 78 16 |
|---|---|
| alex.dumont@orange.sn |
Public
HYGEA Senegal
-
-
Senegal
| hygea@sentoo.sn |
Public
CAREF Mali
-
-
Mali
| Mamadou.konate@caref.org |
Study information
| Study design | Multicentre international two-arm randomised cluster trial of educational nature |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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]) |
| Study acronym | QUARITE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2007 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 174 688 women nested in 44 hospitals |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/11/2011 |
Locations
Countries of recruitment
- Canada
- Mali
- Senegal
Study participating centre
H2W 1V1
Canada
Sponsor information
Hospital/treatment centre
c/o Sylvie Cossette
3175 Cote Sainte Catherine
Montreal
Quebec
H3T 1C5
Canada
| Phone | +1 (0)514 345 4931 ext. 5657 |
|---|---|
| sylvie.cossette@recherche-ste-justine.qc.ca | |
| Website | http://www.recherche-sainte-justine.qc.ca/en |
"ROR" |
https://ror.org/01gv74p78 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/09/2009 | Yes | No | |
| Results article | results | 29/10/2012 | Yes | No | |
| Results article | results | 25/01/2013 | Yes | No | |
| Results article | results | 13/07/2013 | Yes | No |
Editorial Notes
25/05/2017: Plain English summary added.
