Improving the quality of maternal and newborn health services in high priority districts in Malawi

ISRCTN	ISRCTN59931298
DOI	https://doi.org/10.1186/ISRCTN59931298
Secondary identifying numbers	LRPS-2017-9136548

Submission date: 17/08/2018
Registration date: 30/10/2018
Last edited: 02/10/2024

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
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

Contact information

Prof Florence Mgawadere
Scientific

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

ORCID ID	0000-0003-3341-9118

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	Cluster randomized incomplete stepped wedge trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Using standard based audit to improve the quality of maternal and newborn health in a low resource setting
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2018
Completion date	28/02/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	8,100
Key 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
Key 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
Date of first enrolment	31/07/2018
Date of final enrolment	31/12/2018

Locations

Countries of recruitment

Malawi

Study participating centres

Dedza District Hospital

Dedza district
Dedza
00
Malawi

Mayani Health Centre

Dedza district
Dedza
00
Malawi

Lobi Health Centre

Dedza district
Dedza
00
Malawi

Chitowo Health Centre

Dedza district
Dedza
00
Malawi

Mtakataka Health Centre

Dedza district
Dedza
00
Malawi

Mtendere Health Centre

Dedza district
Dedza
00
Malawi

Chikuse Health Centre

Dedza district
Dedza
00
Malawi

Golomoti Health Centre

Dedza district
Dedza
00
Malawi

Chimoto Health Centre

Dedza district
Dedza
00
Malawi

Mangochi district hospital

Mangochi District
Mangochi
00
Malawi

Monkeybay Community Hospital