Making it Happen: reducing maternal and neonatal deaths in South Africa; healthcare facility level assessment of in-service training in emergency obstetric and early newborn care for staff working in maternity services in twelve districts in RSA

ISRCTN	ISRCTN11224105
DOI	https://doi.org/10.1186/ISRCTN11224105
Secondary identifying numbers	N/A

Submission date: 26/08/2016
Registration date: 08/09/2016
Last edited: 27/01/2020

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

Background and study aims
Globally, every year 303,000 women die due to pregnancy-related complications, 2.6 million babies are stillborn and a further 2.7 million die in the first month of life. Many of these deaths occur in low and middle income countries and the majority of them are preventable. Poor emergency care is one of the major contributors to the unacceptably high death rates for mothers and newborns in South Africa. Improving emergency care is known to reduce death rates. It is critical for healthcare providers to have up-to-date knowledge and skills. Short training programs are a recognised means of improving the quality of care for patients. This study aims to improve the knowledge and skills of healthcare workers in maternity services in South Africa through two packages: Essential Steps in Managing Obstetric Emergencies (ESMOE) and Emergency Obstetric Simulation Training (EOST).

Who can participate?
Staff from healthcare facilities providing emergency obstetric and newborn care in 12 districts in the Republic of South Africa

What does the study involve?
Healthcare providers at all facilities regularly have the EOST ‘fire-drill’ exercises (short, hands-on, participatory, on the job training) as a means of boosting their knowledge and skills. Additionally, all healthcare providers receive a one-off training using the ESMOE package (2- or 3-day training with a mix of teaching methods using theoretical and practical sessions). This training is introduced at different times to measure the effect of introducing the additional training and to find out how it affects patients and whether it reduces the number of deaths.

What are the possible benefits and risks of participating?
Staff taking part in the training benefit from refresher training which increases their ability to provide care to mothers and babies. There are no risks of taking part in the study.

Where is the study run from?
133 facilities in the selected districts in South Africa; all work is coordinated through the MRC departments at the University of Pretoria and the Centre for Maternal and Newborn Care at the Liverpool School of Tropical Medicine in the UK.

When is the study starting and how long is it expected to run for?
September 2011 to January 2018

Who is funding the study?
Department for International Development (DFID) UK and DFID South Africa

Who is the main contact?
Prof. Nynke van den Broek

Contact information

Prof Nynke van den Broek
Scientific

Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

ORCID ID	0000-0001-8523-2684

Study information

Study design	Multicentre stepped-wedge cluster-controlled interventional study
Primary study design	Interventional
Secondary study design	Stepped-wedge randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Making it Happen: reducing maternal and neonatal deaths in South Africa; healthcare facility level assessment of in-service training in emergency obstetric and early newborn care for staff working in maternity services in twelve districts in RSA
Study objectives	This study aims to identify the most effective method of providing in-service training in emergency obstetric and newborn care to help to reduce maternal and neonatal mortality in South Africa. With two approaches applied in the study, the null hypothesis is that in-service training in emergency obstetric and early newborn care delivered under Essential Steps in Managing Obstetric Emergencies (ESMOE) package is no different in terms of its effectiveness in reducing maternal and newborn mortality from delivering Emergency Obstetric Simulation Training (EOST) training in healthcare facilities.
Ethics approval(s)	1. Ethics Committee of the Faculty of Health Sciences, University of Pretoria, 30/05/2012, ref: 89/2012 2. Study granted an ethics review exemption by the Liverpool School of Tropical Medicine Research and Ethics Committee, 13/05/2016
Health condition(s) or problem(s) studied	In-service training in emergency obstetric and early newborn care
Intervention	Two types of training approaches to be used to build capacity of healthcare providers in maternity services to provide emergency obstetric and early newborn care in twelve districts in the Republic of South Africa: 1. Emergency Obstetric Simulation Training (EOST) package: Training of trainers on ESMOE provided for lead doctor and midwife per participating facility. Having completed the training, those healthcare providers to act subsequently as facilitators of EOST in their workplaces by organising regular ‘fire-drill’ sessions on selected aspects of emergency obstetric and newborn care for staff present in the ward during the time of the session. 2. Essential Steps in Managing Obstetric Emergencies (ESMOE) package: Training to be delivered in two forms: 2-day training for lower level cadres and 3-day for medical officers and above, with materials adjusted to meet the needs of specific types of participants. This training is to be delivered once per study period to staff in facilities designated to provide emergency care to mothers and babies in the selected twelve districts. Both interventions to be delivered at all participating facilities; training of trainers to deliver EOST to be done at the start of the trial in all sites (and subsequently rolled out repeatedly to staff over the duration of the trial); ESMOE training delivered at different time points in the twelve districts based on the randomisation of districts (in line with stepped wedge design). All facilities within a district are to be trained a time period of ca. 6-8 weeks. Sufficient number of trainings on ESMOE to be provided to ensure a minimum of 80% of staff within a district have been trained (saturation approach) to ensure a critical mass of staff are trained.
Intervention type	Other
Primary outcome measure	All outcomes are to be measured monthly in each facility (according to the stepped wedge design) over the study period (26 months): 1. Facility-level stillbirth rate (number of stillbirths per 1000 births) 2. Facility-level maternal case fatality rate for direct obstetric complications (number of maternal deaths due to direct obstetric complications per 100 cases of direct emergency obstetric complications) 3. Facility-level early newborn death rate (number of early newborn deaths per 1000 live births) 4. Facility-level maternal mortality ratio (number of maternal deaths per 100,000 live births)
Secondary outcome measures	Number of women seeking care in healthcare facilities measured in each facility each month (according to the stepped wedge design) over the course of the study period (26 months)
Overall study start date	30/09/2011
Completion date	31/01/2018

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	Both
Target number of participants	In total, est. 3000 healthcare providers working in maternity services in the 12 districts to be trained in ESMOE; for the purpose of the facility level assessment, all staff at 133 healthcare facilities included in the study to be trained through both EOST and ESMOE training approaches
Key inclusion criteria	Note: Assessment of intervention done at healthcare facility level 1. Districts for the intervention were identified by the National Department of Heath because of poor health outcomes measured by institutional maternal mortality ration and district level stillbirth rate (within RSA). This is an externally-driven selection and is not representative of all regions in the Republic of South Africa. The final number of eligible districts is 12 2. Within the identified districts, all healthcare facilities designated to provide emergency obstetric and newborn care services as basic (BEmOC) and comprehensive (CEmOC) level in the districts to be included in the study (staff invited for training). The total number of such facilities identified is 136 3. Ultimate inclusion in the study based on ability to provide necessary data for monitoring the results of the intervention. The total number of such facilities is 133. (Other facilities meeting the first two criteria are eligible for inclusion in the training but not the measurement of effectiveness)
Key exclusion criteria	1. Facilities in non-selected districts 2. Facilities not designated to provide emergency obstetric and newborn care services as basic (BEmOC) or comprehensive (CEmOC) level 3. Facilities unable to provide data for assessing results of the intervention (this is only a criterion for inclusion in the facility-based assessment and does not exclude staff in those facilities being included in training)
Date of first enrolment	01/07/2012
Date of final enrolment	31/03/2015

Locations

Countries of recruitment

England
South Africa
United Kingdom

Study participating centres

Liverpool School of Tropical Medicine

Centre for Maternal and Newborn Health
L3 5QA
United Kingdom

University of Pretoria

Faculty of Health Sciences
-
South Africa

Connie Vorster-Hartswater Memorial Hospital

Francis Baard district
-
South Africa

Galeshewe Day Hospital

Francis Baard district
-
South Africa

Jan Kemp Dorp Hospital

Francis Baard district
-
South Africa

Kimberley Hospital

Francis Baard district
-
South Africa

Prof Z.K Matthews (Barclay West) Hospital

Francis Baard district
-
South Africa

Warrenton Hospital

Francis Baard district
-
South Africa

Bafokeng Health Centre

Bojanala district
-
South Africa

Bapong

Bojanala district
-
South Africa

Boitekong CHC

Bojanala district
-
South Africa

Chaneng

Bojanala district
-
South Africa

Hartebeesfontein Clinic

Bojanala district
-
South Africa

Ikhutseng Clinic (Klipgat)

Bojanala district
-
South Africa

Jst Hospital

Bojanala district
-
South Africa

Koster Hospital

Bojanala district
-
South Africa

Letlhabile

Bojanala district
-
South Africa

Mabieskraal

Bojanala district
-
South Africa

Mathibestad

Bojanala district
-
South Africa

Mogwase

Bojanala district
-
South Africa

Moretele

Bojanala district
-
South Africa

Moses Kotane Hospital

Bojanala district
-
South Africa

Oukasie Maternity

Bojanala district
-
South Africa

Pella

Bojanala district
-
South Africa

Rekopantswe

Bojanala district
-
South Africa

Seaparankwe PHC

Bojanala district
-
South Africa

Swartruggens Hospital

Bojanala district
-
South Africa

Tlhabane Health Centre

Bojanala district
-
South Africa

Amajuba Memorial Hospital

Gert Sibande district
-
South Africa

Amsterdam CHC

Gert Sibande district
-
South Africa

Badplaas CHC

Gert Sibande district
-
South Africa

Bethal Hospital

Gert Sibande district
-
South Africa

Carolina Hospital

Gert Sibande district
-
South Africa

Elsie Ballot

Gert Sibande district
-
South Africa

Embalenhle

Gert Sibande district
-
South Africa

Embhuleni Hospital

Gert Sibande district
-
South Africa

Ermelo

Gert Sibande district
-
South Africa

Evander Hospital

Gert Sibande district
-
South Africa

Paulinah Morapedi CHC

Gert Sibande district
-
South Africa

Piet Retief Hospital

Gert Sibande district
-
South Africa

Siyathemba

Gert Sibande district
-
South Africa

Standerton Hospital

Gert Sibande district
-
South Africa

Ellisras

Waterberg district
-
South Africa

F.H. Odendaal

Waterberg district
-
South Africa

George Masebe

Waterberg district
-
South Africa

Mokopane

Waterberg district
-
South Africa

Mookgopong Health Centre

Waterberg district
-
South Africa

Thabaleshoba Health Centre

Waterberg district
-
South Africa

Thabazimbi

Waterberg district
-
South Africa

Voortrekker Hospital

Waterberg district
-
South Africa

Warmbaths Hospital

Waterberg district
-
South Africa

Witpoort Hospital

Waterberg district
-
South Africa

Catherine Booth

Uthungulu district
-
South Africa

Ekombe Hospital

Uthungulu district
-
South Africa

Eshowe Hospital

Uthungulu district
-
South Africa

Kwamagwaza

Uthungulu district
-
South Africa

Lower Umfolozi District War Memorial Hospital (LUWMH)

Uthungulu district
-
South Africa

Mbongolwane

Uthungulu district
-
South Africa

Ngwelezana Clinic

Uthungulu district
-
South Africa

Nkandla Hospital

Uthungulu district
-
South Africa

Nseleni Community Health Centre

Uthungulu district
-
South Africa

Thokozani Clinic

Uthungulu district
-
South Africa

Appelsbosch Hospital

Umgungundlovu district
-
South Africa

Bruntville CHC

Umgungundlovu district
-
South Africa

East Boom

Umgungundlovu district
-
South Africa

Edendale Hospital

Umgungundlovu district
-
South Africa

Greys Hospital

Umgungundlovu district
-
South Africa

Imbalenhle Community Health Centre

Umgungundlovu district
-
South Africa

Northdale Hospital

Umgungundlovu district
-
South Africa

Richmond Clinic

Umgungundlovu district
-
South Africa

Gamalakhe

Ugu district
-
South Africa

GJ Crookes Hospital

Ugu district
-
South Africa

Murchison Hospital

Ugu district
-
South Africa

Ntabeni Clinic

Ugu district
-
South Africa

Port Shepstone Hospital

Ugu district
-
South Africa

St Andrews Hospital

Ugu district
-
South Africa

Turton CHC

Ugu district
-
South Africa

Bertha Gxowa-Germiston Hospital

Ekurhuleni district
-
South Africa

Esanyweni Mou

Ekurhuleni district
-
South Africa

Far East Rand

Ekurhuleni district
-
South Africa

J Dumane

Ekurhuleni district
-
South Africa

Kwa-Thema Mou

Ekurhuleni district
-
South Africa

Natalspruit

Ekurhuleni district
-
South Africa

Nokuthela Ngwenya

Ekurhuleni district
-
South Africa

O R Tambo

Ekurhuleni district
-
South Africa

Philip Moyo

Ekurhuleni district
-
South Africa

Phola Park

Ekurhuleni district
-
South Africa

Pholosong Hospital

Ekurhuleni district
-
South Africa

Ramakonop

Ekurhuleni district
-
South Africa

Tembisa

Ekurhuleni district
-
South Africa

Adelaide Hospital