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ISRCTN
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ISRCTN67206260
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ClinicalTrials.gov identifier
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Public title
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Do facility-based audits help West African hospitals to provide better care for patients with obstetric emergencies?
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Scientific title
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Effectiveness of facility-based audits to improve the responsiveness of West African district hospitals to obstetric emergencies: a three-country cluster randomised controlled trial
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Acronym
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AUDOBEM-AFRO
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Serial number at source
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32336
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Study hypothesis
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Facility-based audits improve the quality of care for obstetric emergencies, shorten the delay between decision for and start of an emergency caesarean section, and decrease peri-natal mortality.
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Ethics approval
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1. London School of Hygiene and Tropical Medicine Ethics Committee on the 22nd November 2004 (ref: 2053)
2. Republique du Benin, Ministere de la sante, Direction de la recherche en sante on the 12th September 2007 (ref: 9535/MS/DC/SGM/DRS/SRAO/SA)
3. Burkina Faso, Ministere de la sante/Ministere des enseignements secondaires superieures et de la recherche scientifique, Comite d'ethique pour la recherche en sante on the 17th July 2007 (ref: 2007-050)
4. Republique du Niger, Ministere de la sante publique, Direction Generale de la sante publique on the 14th December 2007 (ref: 45/MSP/DGSP)
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Study design
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Three-armed, unmasked, multicentre, stratified restricted random allocation, cluster-randomised controlled trial
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Countries of recruitment
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Benin, Burkina Faso, Niger
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Disease/condition/study domain
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Major life threatening obstetric complications: haemorrhage, uterine rupture, eclampsia, septicaemia
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Participants - inclusion criteria
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1. District hospitals, supplemented by regional hospitals where number of eligible district hospitals was insufficient
2. Minimum number of births/year: 500 in Benin, 600 in Burkina Faso, 1000 in Niger
3. Minimum 50 caesarean sections/year
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Participants - exclusion criteria
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1. Audits of obstetric near-miss morbidity already underway
2. Insecurity (Niger, desert region)
3. Unclear status as in health system (certain confessional hospitals in Benin)
4. Inability of key staff to communicate in French (Hospital in Burkina Faso run by Chinese Cooperation)
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Anticipated start date
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01/11/2008
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Anticipated end date
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31/10/2010
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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36 hospitals
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Interventions
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Prior to the trial, a 3 - 5 day refresher course on clinical management of major obstetric complications, use of partogramme and essential clinical documentation has been given to staff of all 36 participating hospitals.
The intervention to be evaluated consists of 3 - 5 days staff training sessions on criterion-based clinical audit (CBCA) (12 hospitals) or alternatively on patient-centred case reviews (PCCR) (12 hospitals). The 12 hospitals in the control arm did not receive any training on audits. The follow-up period for all trial arms lasts 24 months.
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Primary outcome measure(s)
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1. Quality of care score, based on compliance with adapted WHO treatment guidelines
2. Delay between decision for and start of emergency caesarean section
3. Perinatal mortality in mature newborns without malformations and, in the case of stillbirths, without signs of maceration. Maturity defined as gestational age greater than or equal to 35 weeks or gestational age greater than or equal to 8 months or birth weight greater than or equal to 200 g or length greater than or equal to 45 cm
Comparison based on period month -6 to -1 before audit training versus period month +7 to +24 after audit training, with period month +1 to +6 considered as run-in period.
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Secondary outcome measure(s)
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Secondary analyses will be used to generate hypotheses only, not to judge the success of the audit interventions.
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Sources of funding
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European Commission (Belgium) - Research Directorate-General, INCO programme (Contract no.: 032336)
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Trial website
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http://www.lshtm.ac.uk/ideu/mp/audobem/
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Publications
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Contact name
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Dr
Matthias
Borchert
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Address
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London School of Hygiene & Tropical Medicine
Infectious Disease Epidemiology Unit
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Sponsor
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European Commission (Belgium) - Research Directorate-General
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Address
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c/o Albrecht Jahn, MD, PhD
Scientific Officer
Unit F2 - Public Health
Office: CDMA Room 02/02
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City/town
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Brussels
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Zip/Postcode
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B-1049
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Country
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Belgium
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Sponsor website:
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http://ec.europa.eu/dgs/research/index_en.html
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Date applied
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29/09/2008
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Last edited
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21/10/2008
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Date ISRCTN assigned
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21/10/2008
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