Objective: To develop a set of core outcomes for studies on pregnant women with epilepsy.
Design: Delphi consensus study.
Population: Healthcare professionals, and patient representatives with lived experience of epilepsy in the UK.
Methods: We used a modified Delphi method and a consultation meeting to achieve consensus. Potential outcomes were identified by systematic review, and were scored using a Likert scale anchored between 1 (least important) and 5 (most important). We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants.
Main outcome measures: Outcomes in studies on epilepsy in pregnancy.
Results: Seventy-five healthcare professionals completed the first round, 48 (64%) completed the second round, and 37 (49%) completed the third round of the survey. Twenty-four patient representatives participated. The final core outcome set included 31 outcomes in three domains: neurological, offspring, and obstetric. Outcomes in the neurological domain were seizure control in pregnancy and postpartum, status epilepticus, maternal mortality, drowning, sudden unexpected death in epilepsy, postnatal depression, and quality of life. Offspring domain included congenital abnormalities (major and minor), fetal anticonvulsant syndrome, neurodevelopment, autism disorder, neonatal clinical complications, admission to a neonatal intensive care unit, and anthropometric measurements. The obstetric domain included live birth, stillbirth, miscarriage, ectopic, termination of pregnancy, admission to a high dependency or intensive care unit, breastfeeding, mode of delivery, preterm birth, pre-eclampsia, and eclampsia. Outcomes specific for studies on anti-epileptic drugs (AEDs) included maternal AED toxicity, AED compliance, neonatal withdrawal symptoms, and neonatal haemorrhagic disease.
Conclusion: Embedding this core set in future clinical trials will promote the standardisation of reporting to inform clinical practice.
Tweetable abstract: A Delphi method identifying core outcomes for epilepsy in pregnancy. Final core set includes 31 outcomes.
Keywords: CROWN; Core outcomes; Delphi; epilepsy; pregnancy.
© 2016 Royal College of Obstetricians and Gynaecologists.