Prevention of cerebral palsy in pre-term labour

PReCePT Study – A cluster randomised trial evaluating the impact of an enhanced support implementation of the PReCePT quality improvement toolkit to increase the uptake of magnesium sulphate in pre-term deliveries for the prevention of neurodisabilities

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40938673

Enrollment

Registered

2020-03-04

Start date

2018-08-23

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Neonatal health Pregnancy and Childbirth

Interventions

The PReCePT Study is a multicentre randomised controlled trial (non-blinded) that will be embedded in the national PReCePT Programme (NPP). Maternity units in England that are part of the NPP are pote

Forty-eight maternity units in England will be randomised to either receive the enhanced support model (16 units) or be observed while implementing the standard support model (32 units).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Units in England participating in national PReCePT Programme (NPP) 2. Units with minimum of 10 preterm (<30 weeks GA) births in 2016 3. Units with 70% or less magnesium sulphate uptake in 2016

Exclusion criteria

Exclusion criteria: Units previously participating in PReCePT1

Design outcomes

Primary

Measure	Time frame
The proportion of eligible mothers given MgSO4 in the 9 months after the implementation of the QI intervention, adjusting for the proportion in the 12 months before implementation	—

Secondary

Measure	Time frame
1. Proportion of preterm babies receiving MgSO4 will be analysed, testing for step-change or change in trend in the 12-month period before, during (9 months) and 9-month period after the implementation of the PReCePT QI package. 2. Completeness of registration of MgSO4 use and reasons not given MgSO4 (proportion of missing entries) will be measured at baseline (the 12-month period before implementation) and 9 months after the implementation of the QI intervention 3. Health economic evaluation – the estimation of the policy cost-effectiveness involving the identification, measurement and valuation of resources used for the different phases of the enhanced QI (i.e., developmental, organising, executing and sustainability costs) versus the standard support during the 9 months of the intensive coaching and three months of sustainability 4. Process evaluation using qualitative interviews carried out prior to the end of the period of implementation with follow-up interviews carried out at the end of the evaluation period to inform sustainability assessment. Process evaluation – will include: 4.1. Proportion of staff receiving training 4.2. Type of staff receiving training (job role) 4.3. Number and duration of training sessions for each unit 4.4. Time required to deliver / receive training 4.5. Staff confidence post training 4.6. Number of staff meetings and staff present where feedback reports are discussed 4.7. Previous experience with QI projects in each unit 4.8. Other ongoing (QI/scientific) projects in each unit 4.9. Organisational/restructuring activities in unit/department 4.10. Understaffing, changes in management/senior staff, etc. 4.11. Adherence to activities and actions of the PReCePT QI toolkit 4.12. Staff involvement and	—

Measure

Time frame

1. Proportion of preterm babies receiving MgSO4 will be analysed, testing for step-change or change in trend in the 12-month period before, during (9 months) and 9-month period after the implementation of the PReCePT QI package. 2. Completeness of registration of MgSO4 use and reasons not given MgSO4 (proportion of missing entries) will be measured at baseline (the 12-month period before implementation) and 9 months after the implementation of the QI intervention 3. Health economic evaluation – the estimation of the policy cost-effectiveness involving the identification, measurement and valuation of resources used for the different phases of the enhanced QI (i.e., developmental, organising, executing and sustainability costs) versus the standard support during the 9 months of the intensive coaching and three months of sustainability 4. Process evaluation using qualitative interviews carried out prior to the end of the period of implementation with follow-up interviews carried out at the end of the evaluation period to inform sustainability assessment. Process evaluation – will include: 4.1. Proportion of staff receiving training 4.2. Type of staff receiving training (job role) 4.3. Number and duration of training sessions for each unit 4.4. Time required to deliver / receive training 4.5. Staff confidence post training 4.6. Number of staff meetings and staff present where feedback reports are discussed 4.7. Previous experience with QI projects in each unit 4.8. Other ongoing (QI/scientific) projects in each unit 4.9. Organisational/restructuring activities in unit/department 4.10. Understaffing, changes in management/senior staff, etc. 4.11. Adherence to activities and actions of the PReCePT QI toolkit 4.12. Staff involvement and

—

Countries

England, United Kingdom

Outcome results

None listed

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