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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59931298
Enrollment
8100
Registered
2018-10-30
Start date
2018-07-31
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recipient of obstetric or newborn care Pregnancy and Childbirth

Interventions

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

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026