Condition category
Pregnancy and Childbirth
Date applied
17/08/2018
Date assigned
30/10/2018
Last edited
30/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
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 can be prevented if effective and good quality of care is available. Malawi is one of the countries in sub-Saharan Africa with high maternal and newborn deaths. The maternal mortality ratio is 634 deaths per 100,000 live births, representing about 15% of all deaths of women in the reproductive age group (15-49 years). The Malawi demographic survey for 2015-2016 reported a newborn mortality rate of 27 deaths per 1,000 live births, infant mortality of 42 deaths per 1,000 live births, and perinatal mortality at 35 deaths per 1,000 pregnancies. About 43% of all deaths occur during the first month of life. Poor quality of care is one of the major contributors to the unacceptably high death rates for mothers and newborns in Malawi. With the transition from Millennium Development Goals to the new global Sustainable Development Goals, absolute targets have been set to reduce maternal deaths, stillbirth and newborn mortality and there is still more to be done. Improving quality of care for mothers and babies is of the utmost urgency. The aim of this study is to assess the impact of using a standards-based audit on compliance with defined standards for emergency obstetric and newborn care to improve quality of maternal and newborn health care in Malawi.

Who can participate?
Women and their newborns who attend 43 healthcare facilities providing emergency obstetric and newborn care within five districts in Malawi

What does the study involve?
The intervention is the adoption by a healthcare facility of standards-based audits for standards of emergency obstetric and newborn care. The aim of the study is to estimate the improvement in compliance with the standard of care when adopting standards-based audits. Training in the conduct of standards-based audit for maternal and newborn health is provided before starting any audit cycle at each facility. For each defined standard the intervention is the action taken in the second month of an audit cycle (the ‘action month’) within the facility to address any deficiencies in care identified during the first month of the audit cycle. Within each facility there are two consecutive audit cycle periods, i.e. the study period is six months in total. For the participating facilities the study period starts in one of three consecutive months, which have been randomly allocated, thus the study period for the entire study is eight calendar months.

What are the possible benefits and risks of participating?
There are no direct benefits for a participant in the study. Staff may benefit from training which increases their ability to deliver quality care to mothers and babies. Compliance to standard is expected to improve service delivery and subsequently improve women and newborn outcomes (reduce morbidities and mortalities) and contribute to client satisfaction with care. There are no risks of taking part in the study.

Where is the study run from?
Liverpool School of Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
March 2018 to February 2019

Who is funding the study?
UNICEF

Who is the main contact?
1. Prof. Florence Mgawadere
2. Prof. Nynke van den Broek

Trial website

Contact information

Type

Scientific

Primary contact

Prof Florence Mgawadere

ORCID ID

http://orcid.org/0000-0003-3341-9118

Contact details

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

Type

Scientific

Additional 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

LRPS-2017-9136548

Study information

Scientific title

Using standard based audit to improve the quality of maternal and newborn health in a low resource setting

Acronym

Study hypothesis

Introducing the practice of conducting standards-based audits within facilities providing emergency obstetric and newborn care in Malawi will improve compliance to standards of care.

Ethics approval

1. Ethics committee of Liverpool School of Tropical Medicine e_Research Protocol, 21/06/2018, ref: 18-028
2. Study granted ethics review exemption by the Malawi Ministry of Health, 20/06/2018, ref: QMD/10

Study design

Cluster randomized incomplete stepped wedge trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Recipient of obstetric or newborn care

Intervention

The intervention is the adoption by a healthcare facility of standards-based audits for standards of emergency obstetric and newborn care. Using the stepped wedge design each participating health care facility (cluster) acts as their own control, providing data for standards audited within the facility both prior to and subsequent to the action phase of the audit cycle.

The aim of the study is to estimate the improvement in compliance with the standard of care when adopting standards-based audits. Training in the conduct of standards-based audit for maternal and newborn health will be provided prior to commencing any audit cycle at each facility.

For each defined standard the intervention will be the action taken in the second month of an audit cycle (the ‘action month’) within the facility to address any deficiencies in care identified during the first month of the audit cycle. Within each facility there will be two consecutive audit cycle periods, i.e. the study period will be six months in total. (For the participating facilities the study period starts in one of three consecutive months, which have been randomly assigned, thus the study period for the entire study will be eight calendar months).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Compliance with defined standard of care aggregated for all emergency obstetric and newborn care standards audited. This will be defined as the mean across all facilities and standards, with each standard audited by each facility carrying equal weight. (Thus, at facility level the means for CEmOC facilities which audit twice as many standards will carry twice the weight of the BEmOC facilities). Standards will be weighted by the number of facilities which audit the standard). Data collected in the following months for a facility will be used for each facility: months 1 and 6 for all standards; month 3 for the standard(s) audited in the first cycle; and month 4 for the standard(s) audited in the second cycle within the facility. The primary outcome will be derived by appropriate aggregation of estimates for individual standards.

Secondary outcome measures

Compliance with defined standard of care for each of the emergency obstetric and newborn care standards audited in the study. Measurements will be made within months 1 and 3 of each audit cycle. Additionally, in facilities which audit a standard in the first audit cycle there will be a (post-intervention) assessment during month 6 for the facility, i.e. 4 months after the intervention (‘action month’) and in those which audit the standard in the second audit cycle there will be an additional (pre-intervention) assessment during month 1 for the facility, i.e. 4 months before the ‘action month’. A standard-specific tool will be used in each month of data collection at a facility to collect data for 25 clients. The data collected will be used to classify each client as having received/not received care which is compliant with the standard.

Overall trial start date

01/03/2018

Overall trial end date

28/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Clusters:
43 healthcare facilities providing emergency obstetric and newborn care within five districts in Malawi

Clients:
Women and their newborns who attend the study facilities for obstetric/newborn care addressed by the standard being assessed that month

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

8,100

Participant exclusion criteria

1. Women who did not give birth at a healthcare facility
2. Facilities not designated to provide emergency obstetric and newborn care services as basic (BEmOC) or comprehensive (CEmOC) level

Recruitment start date

31/07/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Malawi

Trial participating centre

Dedza District Hospital
Dedza district
Dedza
00
Malawi

Trial participating centre

Mayani Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Lobi Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Chitowo Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Mtakataka Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Mtendere Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Chikuse Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Golomoti Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Chimoto Health Centre
Dedza district
Dedza
00
Malawi

Trial participating centre

Mangochi district hospital
Mangochi District
Mangochi
00
Malawi

Trial participating centre

Monkeybay Community Hospital
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Makanjira Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Koche Community Hospital
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Namwera Health cente
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Ndirande Health Centre
Blantyre District
BlantyreM
00
Malawi

Trial participating centre

Phirilongwe Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Lungwena Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Chilipa Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Chilonga Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Nankumba Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Mkumba Health Centre
Mangochi district
Mangochi
00
Malawi

Trial participating centre

Limbe Health Centre
Blantyre district
Blantyre
00
Malawi

Trial participating centre

South Lunzu Health Centre
Blantyre district
Blantyre
00
Malawi

Trial participating centre

Mlambe Hospital
Blanytre district
Blantyre
00
Malawi

Trial participating centre

Mdeka Health Centre
Blantyre district
Blantyre
00
Malawi

Trial participating centre

Bangwe Health Centre
Blantyre district
Blantyre
00
Malawi

Trial participating centre

Lundu Health Centre
Blantyre district
Blantyre
00
Malawi

Trial participating centre

Zingwangwa Health Centre
Blantyre district
Blanytre
00
Malawi

Trial participating centre

Chilomoni Health Centre
Blantyre district
Blanytre
00
Malawi

Trial participating centre

Thyolo District Hospital
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Malamulo Hospital
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Khonjeni
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Thekerani Health Centre
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Mikolongwe Health Centre
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Chimaliro Health Centre
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Bvumbwe
Thyolo district
Thyolo
00
Malawi

Trial participating centre

Chisoka
Thyolo
Thyolo
00
Malawi

Trial participating centre

Nkhatabay district hospital
Nhkatabay district
Nkhatabay
oo
Malawi

Trial participating centre

Chintheche Community Hospital
Nkhatabay district
Nkhatabay
00
Malawi

Trial participating centre

Mpamba Health Centre
Nkhatabay district
Nkatabay
00
Malawi

Trial participating centre

Liuzi Health Centre
Nkhatabay District
Nkhatabay
00
Malawi

Trial participating centre

Bula Health Centre
Nkkatabay District
Nkhatabay
00
Malawi

Trial participating centre

Mzenga Health Centre
Nkhatabay district
Nkhatabay
oo
Malawi

Trial participating centre

Liverpool School of Tropical Medicine, Malawi office
Private Bag B425
Lilongwe
00
Malawi

Trial participating centre

Mua Hospital
Dedza district
Dedza
00
Malawi

Sponsor information

Organisation

Liverpool School of Tropical Medicine

Sponsor details

Pembroke Place
Liverpool
L3 5QA
United Kingdom

Sponsor type

University/education

Website

https://www.lstmed.ac.uk/

Funders

Funder type

Other

Funder name

UNICEF

Alternative name(s)

United Nations Children's Emergency Fund

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal by mid-2019. Additional documents such as study protocol, statistical analysis plan, other will be available upon request. The protocol is not yet published.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Florence Mgawadere and Prof. Nynke van den Broek. The protocol and the dataset for the standards to be audited will be available from September. The current institutional policy requires that data is kept for 5 years after publication. The anonymised data can be shared for any analysis required upon request through the following institutional email address: CMNH@lstmed.ac.uk. All data will be anonymised and consent will obtained for all the data to be collected and there are no ethical nor legal restrictions at present.

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes