Developing a preconception care pathway for women with epilepsy
Research type
Research Study
Full title
Developing a preconception care pathway for women with epilepsy in the UK: Identifying key interventions and patient-reported outcomes using mixed methods Delphi consensus approach
IRAS ID
276652
Contact name
Janine Beverley Winterbottom
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
Clinicaltrials.gov Identifier
200791, NIHR RfPB
Duration of Study in the UK
1 years, 6 months, days
Research summary
Research Summary
Preconception care is advised for women with epilepsy. It involves taking steps to make sure a woman’s epilepsy and health are optimal before getting pregnant. This is vital because epilepsy and epilepsy drugs can increase the risk of problems for mother and baby. These include:
• Risks of worsening seizure control, if a woman stops taking her epilepsy drugs for fear of harm to the baby. This could increase the chance of injury or even death in epilepsy.
• Risks of birth defects in the baby, if the mother is not taking the best type and dose of an epilepsy drug. This includes valproate (Epilim).
Preconception care offers the chance to avoid some of these risks. However, there is little evidence of its effectiveness, and there is a lack of consistent definition of what this intervention involves or methods of delivery.
Developing a deeper understanding of what is important to achieve from supporting women preparing for pregnancy, will go some way to addressing these problems.
This is a mixed-methods study involving three stages to develop a preconception care pathway for women with epilepsy in the UK. Firstly, we will gain a deeper understanding of preconception care experience of a purposive sample of women with epilepsy, their partners, spouse, family, carers and friends using focus group and interviews. Results from this thematic analysis will be combined with findings from a systematic review and PPI consultation to develop the online Delphi survey. Secondly, patients and clinicians will participate in an iterative consensus exercise known as a Delphi study to refine the content of the preconception care pathway. The third stage will involve a representative panel of patients and clinicians, “key stakeholder”, in a face-to-face consensus meeting to discuss and agree on the final content of the care pathway and patient-reported outcomes.Summary of Results
Why the study was needed The Epilepsy Preconception study aimed to develop a care pathway for women with epilepsy in the UK.
Preconception care is vital because epilepsy and epilepsy drugs can increase the risk of problems for the mother and baby. These include:
- Risks of worsening seizure control if a woman stops taking her epilepsy drugs for fear of harm to the baby. These risks include the chance of injury or even death in epilepsy.
- Risks of developmental problems or congenital disabilities if, in pregnancy, the woman is not taking the best type and dose of an epilepsy drug. These risks include avoiding valproate (Epilim), which has known risks.
Preconception care offers the chance to avoid some of these risks. Because it is unclear why not all women have this support, we completed this study to identify the essential content of preconception care and the support stages.
What we did
In stage 1, we held interviews and focus groups with women with epilepsy, their partners and family and reviewed existing literature. Based on these findings, we developed a survey and conducted a pilot study to fine-tune the questions.
In stage 2, we completed a two-round survey with healthcare professionals, voluntary organisations and women with epilepsy, their partners and family to prioritise the content of preconception care.
In stage 3, we held a consensus meeting with representatives of each stakeholder group.
What we found out
We achieved agreement on the priorities of preconception care. These priorities included knowing about the effects of taking antiseizure medicines during pregnancy and having support to address concerns about seizures and medicines. Feedback agreed a preconception care pathway is beneficial for all involved and that future development is worthwhile. Therefore, we plan to use our learning from this study to plan feasibility trials towards implementation.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0191
Date of REC Opinion
24 Sep 2020
REC opinion
Further Information Favourable Opinion