Improving epilepsy and pregnancy care

Proportion of high-risk pregnant women with epilepsy accessing specialist epilepsy care in first 14 weeks of gestation, calculated as a percentage of all those considered to be at high risk ; Timepoint(s): At 14 weeks of gestation

1. The occurrence of any type of seizure, obtained directly from patient records and clinical notes (key secondary outcome); Timepoint(s): During pregnancy
2. Increase in the frequency or severity of seizures, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
3. Prolonged epileptic seizures lasting 30 minutes or a series of seizures with incomplete return of consciousness (status epilepticus), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
4. Death of pregnant women, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy or within 42 days of termination of pregnancy
5. Occurrence of epileptic seizures that result in altered consciousness, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
6. Accidents or injuries directly resulting from seizure activities, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
7. Any hospital admissions resulting from seizure activity during pregnancy, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
8. Admission to high dependency or intensive care unit for any reason, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
9. Anti-seizure medication adherence during pregnancy, obtained from care provider log; Timepoint(s): During pregnancy
10. Development of new-onset hypertension and proteinuria after 20 weeks of gestation (pre-eclampsia), obtained directly from patient records and clinical notes; Timepoint(s): After 20 weeks of gestation
11. Method of delivery (vaginal or caesarean), obtained directly from patient records and clinical notes; Timepoint(s): At time of delivery of baby
12. Onset of labour before 37 weeks of gestation, obtained directly from patient records and clinical notes; Timepoint(s): At 37 weeks of pregnancy
13. Rupture of membranes before the onset of labour, obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
14. Premature separation of the placenta from the uterine wall (placental abruption), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
15. Blood loss of 500 ml or more from the genital tract within 24 hours of birth (peripartum haemorrhage), obtained directly from patient records and clinical notes; Timepoint(s): Within 24 hours of birth
16. Spontaneous loss of pregnancy before 24 weeks of gestation (miscarriage), obtained directly from patient records and clinical notes; Timepoint(s): At 24 weeks of gestation
17. Implantation of fertilised egg outside the uterus (ectopic pregnancy), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
18. Intentional ending of pregnancy (termination of pregnancy), obtained directly from patient records and clinical notes; Timepoint(s): During pregnancy
19. Initiation of breastfeeding within the first 48 hours postpartum, obtained directly from patient records and clinical notes; Timepoint(s): At 48 hours postpartum
20. Fetal death occurring at or after 24 weeks gestation (stillbirth), obtained directly from patient records and clinical notes; Timepoint(s): End of pregnancy
21. Death of a live-born infant within the first 28 days of life (neonatal death), obtained directly from patient records and clinical notes; Timepoint(s): Within the first 28 days of the infant's life
22. Presence of major structural or genetic abnormalities (congenital abnormalities), obtained directly from patient records and clinical notes; Timepoint(s): At birth
23. Birth occurring before 37 completed weeks of gestation (pre-term birth), obtained directly from patient records and clinical notes; Timepoint(s): At 37 weeks of gestation
24. Weight below the 10th percentile for gestational age at birth, obtained directly from patient records and clinical notes; Timepoint(s): At birth
25. APGAR score <7 at 1 and 5 minutes after birth, obtained directly from patient records and clinical notes; Timepoint(s): At 1 and 5 minutes after birth
26. Neonatal intensive care unit admission for any reason, obtained directly from patient records and clinical notes; Timepoint(s): At birth
27. Blood glucose level 5 mg/dL (2.5 mmol/L) in the first 24 hours of life (hypoglycaemia) obtained directly from patient records and clinical notes; Timepoint(s): In the first 24 hours of the infant’s life
28. Need for neonatal resuscitation measures at birth, obtained directly from patient records and clinical notes; Timepoint(s): At birth
29. Brain injury due to oxygen deprivation around the time of birth (hypoxic-ischemic encephalopathy), obtained directly from patient records and clinical notes; Timepoint(s): At birth
30 Percentage of all women with epilepsy in the intervention arm who receive EpiSafe intervention (REACH), obtained from medical records; Timepoint(s): End of intervention delivery
31. Percentage of booking midwives who complete the EpiSafe training (ADOPTION), obtained from training logs; Timepoint(s): End of intervention delivery
32. Percentage of the components of the EpiSafe bundle delivered according to the protocol (FIDELITY), obtained from medical records; Timepoint(s): Over the duration of a maternity unit's involvement in the study
33. Number of components of the EpiSafe bundle adapted (ADAPTION), obtained from medical notes; Timepoint(s): Over the duration of a maternity unit's involvement in the study
34. Percentage of EpiSafe intervention components delivered (DOSE); Timepoint(s): Over the duration of a maternity unit's involvement in the study
35. Patient and healthcare professional rating of EpiSafe bundle’s suitability for individual sites (APPROPRIATENESS); Timepoint(s): End of intervention delivery
36. Written protocol for management of (i) status epilepticus, (ii) epilepsy in pregnancy obtained from hospital documents; Timepoint(s): End of intervention delivery
37. Percentage of healthcare professionals caring for pregnant women with epilepsy trained in EpiSafe bundle, obtained from training log; Timepoint(s): End of intervention delivery
38. Number of multi-disciplinary team meetings discussing the high-risk women management, obtained from medical records; Timepoint(s): End of pregnancy
39. Implementation of regular audit and feedback cycles for care of epilepsy in pregnancy, obtained from quality improvement report; Timepoint(s): End of intervention delivery
40. Acceptability of the EpiSafe bundle to women, families, healthcare professionals measured via interviews; Timepoint(s): End of intervention delivery
Assessment of the EpiSafe bundle’s adaptability, feasibility and impact on health equity measured via interviews; Timepoint(s): End of intervention delivery
41. Identification of implementation barriers to intervention delivery and study conduct measured via interviews; Timepoint(s): End of intervention delivery
42. Patient reported experience measures (PREMs) on process of care: dignity, information, trust, positive birth experience measured via interviews; Timepoint(s): End of intervention delivery
43. Total cost associated with implementing the EpiSafe bundle measured via an economic evaluation; Timepoint(s): During pregnancy
44. Percentage of pregnant women with epilepsy who undergo a formal assessment of seizure risk and current anti-seizure medication during pregnancy, obtained from medical records; Timepoint(s): During pregnancy
45. Percentage of high-risk pregnant women on anti-seizure medication accessing specialist care within 2 weeks from referral, obtained from medical records; Timepoint(s): During pregnancy
46. Proportion of all women with epilepsy in whom discussion on risk-benefit of seizures and anti-seizure medications recorded during pregnancy, obtained from medical records; Timepoint(s): During pregnancy
47. Percentage of all pregnant women with epilepsy on anti-seizure medication who had a medication review in their first visit with the epilepsy specialist, obtained from medical records; Timepoint(s): At the first visit with an epilepsy specialist
48. Percentage of pregnant women with epilepsy who receive information on epilepsy in pregnancy; Timepoint(s): During pregnancy