Do facility-based audits help West African hospitals to provide better care for patients with obstetric emergencies?

ISRCTN	ISRCTN67206260
DOI	https://doi.org/10.1186/ISRCTN67206260
Secondary identifying numbers	32336

Submission date: 29/09/2008
Registration date: 21/10/2008
Last edited: 30/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Matthias Borchert
Scientific

London School of Hygiene & Tropical Medicine
Infectious Disease Epidemiology Unit
Keppel Street
London
WC1E 7HT
United Kingdom

Study information

Study design	Three-armed unmasked multicentre stratified restricted random allocation cluster-randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Effectiveness of facility-based audits to improve the responsiveness of West African district hospitals to obstetric emergencies: a three-country cluster randomised controlled trial
Study acronym	AUDOBEM-AFRO
Study objectives	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.
Ethics approval(s)	1. London School of Hygiene and Tropical Medicine Ethics Committee, 22/11/2004, ref: 2053 2. Republique du Benin, Ministere de la sante, Direction de la recherche en sante, 12/09/2007, 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, 17/07/2007, ref: 2007-050 4. Republique du Niger, Ministere de la sante publique, Direction Generale de la sante publique, 14/12/2007, ref: 45/MSP/DGSP
Health condition(s) or problem(s) studied	Major life-threatening obstetric complications: haemorrhage, uterine rupture, eclampsia, septicaemia
Intervention	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.
Intervention type	Other
Primary outcome measure	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.
Secondary outcome measures	Secondary analyses will be used to generate hypotheses only, not to judge the success of the audit interventions.
Overall study start date	01/11/2008
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	36 hospitals
Total final enrolment	51
Key inclusion criteria	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
Key exclusion criteria	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)
Date of first enrolment	01/11/2008
Date of final enrolment	31/10/2010

Locations

Countries of recruitment

Benin
Burkina Faso
England
Niger
United Kingdom

Study participating centre

London School of Hygiene & Tropical Medicine

London
WC1E 7HT
United Kingdom

Sponsor information

European Commission (Belgium) - Research Directorate-General
Government

c/o Albrecht Jahn, MD, PhD
Scientific Officer
Unit F2 - Public Health
Office: CDMA Room 02/02
Brussels
B-1049
Belgium

Website	http://ec.europa.eu/dgs/research/index_en.html
"ROR"	https://ror.org/00k4n6c32

Funders

Funder type

Government

European Commission (Belgium) - Research Directorate-General, INCO programme (Contract no.: 032336)

No information available

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	02/05/2014	30/12/2020	Yes	No

Editorial Notes

30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.