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Does training non-physician clinicians, in Malawi, have an impact on new-born baby and maternal survival?

The impact of training non-physician clinicians in Malawi on perinatal / neonate mortality: a cluster randomised controlled evaluation of the Enhancing Training and Appropriate Technologies for Mothers and Babies in Africa (ETATMBA) project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63294155
Enrollment
50
Registered
2012-06-08
Start date
2011-11-01
Completion date
Unknown
Last updated
2017-07-03

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

Conditions

Maternal and neonatal mortality Pregnancy and Childbirth

Interventions

Fifteen districts (clusters) of the Central and Northern Regions of Malawi will be randomly assigned to either receive the intervention or to be a control district. The intervention is the training o

Sponsors

University of Warwick (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A non-physician clinician in Malawi who is receiving ETATMBA training

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Perinatal mortality (defined as fresh stillbirths and neonatal deaths before discharge from the health care facility): Data will be extracted from the maternity log (Malawi Ministry of Health Maternity Register, Ver. 2 (July 2008)) at the district hospital and rural hospitals in each district by the two research assistants monitored by the local and UK team. Other facilities within the district (e.g. health Centres) also complete the same maternity log book from which summary data is returned to the district hospital on a monthly basis. This data will also be gathered by the researchers and the combined data will make up a complete picture of the districts. Data will be collected at three points in time retrospectively (i.e. the year leading up to date). Baseline data will be collected on cases (from the maternity logs and summary logs) for the 12 months prior to the date the training was delivered with two follow-ups at 12 monthly intervals. A paper Case Report Form (CRF) will be produced to facilitate data collection. Data will then be transferred to an MS Excel spread sheet for transfer to the study database.

Secondary

MeasureTime frame
1. Maternal death rates (case specific) 2. Recorded data (e.g. still births, Post-Partum Haemorrhage, C Section, Eclampsia, Sepsis, Neonatal resuscitation) 3. Availability of resources (e.g. are drugs/blood available) 4. Use of available resources (e.g. are drugs being used) Alongside this we plan to carry out a process evaluation of the implementation of the intervention to inform future implementation of interventions like these or to develop it further for the future. The process evaluation will include outcomes which will explore how or why the intervention was either effective or indeed not effective. Including: 1. Challenges faced 2. Acceptability 3. Sustainability Process evaluations particularly help researchers understand the causal pathways by which complex interventions might work and sometimes to interpret equivocal results. The shift towards greater evidence-based-practice means there is a greater need to know why an intervention works and, if it does not, why not. Process evaluation can facilitate this understanding and should be incorporated into the evaluation of health promoting interventions/programmes. Within the intervention districts at the three time points (baseline, 12 and 24 months) the research assistants will approach the consenting NPCs (primarily to interview them, described below) but also to gather information about project related activities (e.g. who they have trained, when they did this, how many training session done, etc.). For process evaluation purposes training registers, adherence to training procedures (during the project period), knowledge scores and training feedback will also be collected and collated from the intervention team. No identifiable data will be recorded (e.g. just numbers of attendances, pre and post scores). Qualitative Data Collection: In the intervention districts interviews will be carried out at each of the three time points with consenting NPCs (who have received the intervention training). These

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026