Condition category
Pregnancy and Childbirth
Date applied
26/08/2016
Date assigned
08/09/2016
Last edited
08/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 July 2016

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nynke van den Broek

ORCID ID

http://orcid.org/0000-0001-8523-2684

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

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

Study design

Multicentre stepped-wedge cluster-controlled interventional study

Primary study design

Interventional

Secondary study design

Stepped-wedge randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

30/09/2011

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Health professional

Age group

Adult

Gender

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

Participant 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)

Recruitment start date

01/07/2012

Recruitment end date

31/03/2015

Locations

Countries of recruitment

South Africa

Trial participating centre

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

Trial participating centre

University of Pretoria
Faculty of Health Sciences
-

Trial participating centre

Connie Vorster-Hartswater Memorial Hospital
Francis Baard district
-

Trial participating centre

Galeshewe Day Hospital
Francis Baard district
-

Trial participating centre

Jan Kemp Dorp Hospital
Francis Baard district
-

Trial participating centre

Kimberley Hospital
Francis Baard district
-

Trial participating centre

Prof Z.K Matthews (Barclay West) Hospital
Francis Baard district
-

Trial participating centre

Warrenton Hospital
Francis Baard district
-

Trial participating centre

Bafokeng Health Centre
Bojanala district
-

Trial participating centre

Bapong
Bojanala district
-

Trial participating centre

Boitekong CHC
Bojanala district
-

Trial participating centre

Chaneng
Bojanala district
-

Trial participating centre

Hartebeesfontein Clinic
Bojanala district
-

Trial participating centre

Ikhutseng Clinic (Klipgat)
Bojanala district
-

Trial participating centre

Jst Hospital
Bojanala district
-

Trial participating centre

Koster Hospital
Bojanala district
-

Trial participating centre

Letlhabile
Bojanala district
-

Trial participating centre

Mabieskraal
Bojanala district
-

Trial participating centre

Mathibestad
Bojanala district
-

Trial participating centre

Mogwase
Bojanala district
-

Trial participating centre

Moretele
Bojanala district
-

Trial participating centre

Moses Kotane Hospital
Bojanala district
-

Trial participating centre

Oukasie Maternity
Bojanala district
-

Trial participating centre

Pella
Bojanala district
-

Trial participating centre

Rekopantswe
Bojanala district
-

Trial participating centre

Seaparankwe PHC
Bojanala district
-

Trial participating centre

Swartruggens Hospital
Bojanala district
-

Trial participating centre

Tlhabane Health Centre
Bojanala district
-

Trial participating centre

Amajuba Memorial Hospital
Gert Sibande district
-

Trial participating centre

Amsterdam CHC
Gert Sibande district
-

Trial participating centre

Badplaas CHC
Gert Sibande district
-

Trial participating centre

Bethal Hospital
Gert Sibande district
-

Trial participating centre

Carolina Hospital
Gert Sibande district
-

Trial participating centre

Elsie Ballot
Gert Sibande district
-

Trial participating centre

Embalenhle
Gert Sibande district
-

Trial participating centre

Embhuleni Hospital
Gert Sibande district
-

Trial participating centre

Ermelo
Gert Sibande district
-

Trial participating centre

Evander Hospital
Gert Sibande district
-

Trial participating centre

Paulinah Morapedi CHC
Gert Sibande district
-

Trial participating centre

Piet Retief Hospital
Gert Sibande district
-

Trial participating centre

Siyathemba
Gert Sibande district
-

Trial participating centre

Standerton Hospital
Gert Sibande district
-

Trial participating centre

Ellisras
Waterberg district
-

Trial participating centre

F.H. Odendaal
Waterberg district
-

Trial participating centre

George Masebe
Waterberg district
-

Trial participating centre

Mokopane
Waterberg district
-

Trial participating centre

Mookgopong Health Centre
Waterberg district
-

Trial participating centre

Thabaleshoba Health Centre
Waterberg district
-

Trial participating centre

Thabazimbi
Waterberg district
-

Trial participating centre

Voortrekker Hospital
Waterberg district
-

Trial participating centre

Warmbaths Hospital
Waterberg district
-

Trial participating centre

Witpoort Hospital
Waterberg district
-

Trial participating centre

Catherine Booth
Uthungulu district
-

Trial participating centre

Ekombe Hospital
Uthungulu district
-

Trial participating centre

Eshowe Hospital
Uthungulu district
-

Trial participating centre

Kwamagwaza
Uthungulu district
-

Trial participating centre

Lower Umfolozi District War Memorial Hospital (LUWMH)
Uthungulu district
-

Trial participating centre

Mbongolwane
Uthungulu district
-

Trial participating centre

Ngwelezana Clinic
Uthungulu district
-

Trial participating centre

Nkandla Hospital
Uthungulu district
-

Trial participating centre

Nseleni Community Health Centre
Uthungulu district
-

Trial participating centre

Thokozani Clinic
Uthungulu district
-

Trial participating centre

Appelsbosch Hospital
Umgungundlovu district
-

Trial participating centre

Bruntville CHC
Umgungundlovu district
-

Trial participating centre

East Boom
Umgungundlovu district
-

Trial participating centre

Edendale Hospital
Umgungundlovu district
-

Trial participating centre

Greys Hospital
Umgungundlovu district
-

Trial participating centre

Imbalenhle Community Health Centre
Umgungundlovu district
-

Trial participating centre

Northdale Hospital
Umgungundlovu district
-

Trial participating centre

Richmond Clinic
Umgungundlovu district
-

Trial participating centre

Gamalakhe
Ugu district
-

Trial participating centre

GJ Crookes Hospital
Ugu district
-

Trial participating centre

Murchison Hospital
Ugu district
-

Trial participating centre

Ntabeni Clinic
Ugu district
-

Trial participating centre

Port Shepstone Hospital
Ugu district
-

Trial participating centre

St Andrews Hospital
Ugu district
-

Trial participating centre

Turton CHC
Ugu district
-

Trial participating centre

Bertha Gxowa-Germiston Hospital
Ekurhuleni district
-

Trial participating centre

Esanyweni Mou
Ekurhuleni district
-

Trial participating centre

Far East Rand
Ekurhuleni district
-

Trial participating centre

J Dumane
Ekurhuleni district
-

Trial participating centre

Kwa-Thema Mou
Ekurhuleni district
-

Trial participating centre

Natalspruit
Ekurhuleni district
-

Trial participating centre

Nokuthela Ngwenya
Ekurhuleni district
-

Trial participating centre

O R Tambo
Ekurhuleni district
-

Trial participating centre

Philip Moyo
Ekurhuleni district
-

Trial participating centre

Phola Park
Ekurhuleni district
-

Trial participating centre

Pholosong Hospital
Ekurhuleni district
-

Trial participating centre

Ramakonop
Ekurhuleni district
-

Trial participating centre

Tembisa
Ekurhuleni district
-

Trial participating centre

Adelaide Hospital
Amathole district
-

Trial participating centre

Bedford Hospital
Amathole district
-

Trial participating centre

Bisho Hospital
Amathole district
-

Trial participating centre

Butterworth
Amathole district
-

Trial participating centre

Cathcart
Amathole district
-

Trial participating centre

Cecilia Makiwane Hospital
Amathole district
-

Trial participating centre

Dimbaza
Amathole district
-

Trial participating centre

Dutywa Health Centre
Amathole district
-

Trial participating centre

Dvdh
Amathole district
-

Trial participating centre

Elliotdale Health Centre
Amathole district
-

Trial participating centre

Empilweni Gompo CHC
Amathole district
-

Trial participating centre

Fort Beaufort Hospital
Amathole district
-

Trial participating centre

Frere Maternity
Amathole district
-

Trial participating centre

Middledrift Health Care
Amathole district
-

Trial participating centre

Nompumelelo Hospital
Amathole district
-

Trial participating centre

Nontyatyambo
Amathole district
-

Trial participating centre

Nqamakwe Health Centre
Amathole district
-

Trial participating centre

S. S. Gida Hospital
Amathole district
-

Trial participating centre

Stutterheim Hospital
Amathole district
-

Trial participating centre

Twafalofefe
Amathole district
-

Trial participating centre

Victoria
Amathole district
-

Trial participating centre

Willowvale CHC
Amathole district
-

Trial participating centre

Boitumelo Regional Hospital
Fezile Dabi district
-

Trial participating centre

Mafube District Hospital
Fezile Dabi district
-

Trial participating centre

Metsimaholo District Hospital
Fezile Dabi district
-

Trial participating centre

Parys Hospital
Fezile Dabi district
-

Trial participating centre

Tokollo
Fezile Dabi district
-

Trial participating centre

Dihlabeng Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Elizabeth Ross Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Itemoheng Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

John Daniel Newberry District Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Mantsopa District Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Mofumahadi Manapo Mopeli Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Nketoane Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Phekelong
Thabo Mofuntsanyane district
-

Trial participating centre

Phumelela District Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Phuthuloha District Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Tebang Clinic
Thabo Mofuntsanyane district
-

Trial participating centre

Thebe Hospital
Thabo Mofuntsanyane district
-

Trial participating centre

Bongani Hospital
Lejweleputswa district
-

Trial participating centre

Katleho Hospital
Lejweleputswa district
-

Trial participating centre

Mohau District Hospital
Lejweleputswa district
-

Trial participating centre

Nala Hospital
Lejweleputswa district
-

Trial participating centre

Thusanong Hospital
Lejweleputswa district
-

Trial participating centre

Winburg Hospital
Lejweleputswa district
-

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor type

University/education

Website

http://www.lstmed.ac.uk

Funders

Funder type

Government

Funder name

Department for International Development

Alternative name(s)

Department for International Development, UK, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

31/07/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes