Condition category
Pregnancy and Childbirth
Date applied
29/09/2008
Date assigned
21/10/2008
Last edited
10/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lshtm.ac.uk/ideu/mp/audobem/

Contact information

Type

Scientific

Primary contact

Dr Matthias Borchert

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32336

Study information

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

Acronym

AUDOBEM-AFRO

Study hypothesis

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

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

Study design

Three-armed unmasked multicentre stratified restricted random allocation cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/11/2008

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

36 hospitals

Participant 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)

Recruitment start date

01/11/2008

Recruitment end date

31/10/2010

Locations

Countries of recruitment

Benin, Burkina Faso, Niger

Trial participating centre

London School of Hygiene & Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

European Commission (Belgium) - Research Directorate-General

Sponsor details

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

Sponsor type

Government

Website

http://ec.europa.eu/dgs/research/index_en.html

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes