EpiSafe Study

Evaluating the impact of the EpiSafe bundle on care and clinical outcomes for pregnant women with epilepsy and their babies

A cluster randomised hybrid implementation-effectiveness trial with process evaluation, qualitative study, and economic evaluation.

Aim

To evaluate the impact of using the EpiSafe bundle at antenatal bookings on the care and
clinical outcomes of pregnant women with epilepsy and their babies.

Study Design

This is a multicentre, parallel, two-arm cluster randomised trial with baseline. Clusters are maternity units in which pregnant women with epilepsy are booked for antenatal care. The cluster randomisation in the trial means that participating maternity units will be randomised into either the intervention arm (EpiSafe bundle) or the control arm. The intervention is applied at the cluster level and all pregnant women with epilepsy booked in the participating units will be included.

Primary Objective

Does the EpiSafe bundle increase the number of high-risk women accessing specialist epilepsy care before 14 weeks’ pregnancy?

Secondary Objective

Does EpiSafe reduce seizures in pregnancy until after birth?

Other Objectives

Effects on seizure control, pregnancy complications, medication use, and outcomes for babies.

Implementation

How many women receive the EpiSafe bundle
How many staff are trained
How well the bundle fits into routine maternity care

Qualitative Outcomes

Acceptability of the EpiSafe bundle to women & healthcare professionals

Barriers to delivering the intervention & running the study

Patient-reported experience measures (PREMs)

Data Use

We will use anonymised routine NHS data only.
We will not access identifiable information.

If you do not want your anonymised information to be used for this and other research purposes, you can opt out easily:

England: Use the National Data Opt-Out service or call 0300 303 5035
Scotland: Contact your maternity team, local NHS Data Protection Officer, or visit NHS Inform
Northern Ireland: Ask your GP to register your opt-out
Wales: No specific opt-out process is available at present