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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Shakila
Thangaratinam
shakila.thangaratinam@lwh.nhs.uk
Oladipupo
Olalere
o.i.olalere@bham.ac.uk
John
j.allotey.1@bham.ac.uk
j.allotey.1@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Episodic and paroxysmal disordersOther obstetric conditions, not elsewhere classified
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Background: Epilepsy is the second highest indirect cause of mothers dying during pregnancy or after childbirth in the UK. Pregnant women with epilepsy have an increased risk of miscarriage, high blood pressure and pre-term birth. Mothers have concerns about the side effects of the medications on their babies. There is a need for robust evidence to support healthcare practitioners assess pregnant women with epilepsy and improve care to reduce seizures, optimise anti-epileptic drug use and reduce complications for mother and baby.
Aim: To develop an evidence based structured risk assessment intervention (Epi-Safe Bundle) for health care practitioners to assess and provide best care for pregnant women with epilepsy.
Methods: Two work packages (WP1, 2).
WP 1: Pregnant women with epilepsy and healthcare practitioner perspectives on receiving or delivering care:
i) Focus groups and/or interviews with women with epilepsy who are, or have been, pregnant will be conducted to identify their care priorities and concerns and to explore their perspectives on care provision, access and needs for optimal epilepsy care during pregnancy.
ii) Focus groups and/or interviews with health care practitioners will be conducted to identify healthcare practitioners’ barriers and facilitators to implementing a risk assessment intervention for pregnant women with epilepsy and delivering other related elements of care (e.g., treatment plan, communicating risk).
WP 2: Test the Epi-Safe intervention package (bundle) and implementation strategies:
We will then develop the “bundle” (this is quality improvement work and is therefore not part of this ethics application –noted to provide context for reviewers).
iii) Feasibility testing of Epi-Safe through a rapid ethnographic assessment, which will include use of scenarios. We will provide the Epi-Safe Bundle for healthcare practitioners to test in practice. We will establish with them how useful strategies are and modify based on feedback for future testing.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Qualitative;
You can take part if:
You may not be able to take part if:
1. Interviews with women: Does not have diagnosed epilepsy, never taken AEDs, previous pregnancy > 24 months from point of interview/focus group, < 18 years of age, non-NHS maternity service-user, unwilling or unable to consent independently. 2. Interviews with healthcare practitioners. Healthcare practitioner with no responsibility for the review and management of women with epilepsy. Non-NHS employee/practitioner, unwilling or unable to consent independently. 3. Field testing the intervention (observations, PDSA cycles and evaluation survey): Healthcare practitioners who have no responsibility for the review and management of women with epilepsy. Non-NHS employee/practitioner, unwilling or unable to consent.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Oladipupo
Olalere
o.i.olalere@bham.ac.uk
Shakila
Thangaratinam
shakila.thangaratinam@lwh.nhs.uk
John
j.allotey.1@bham.ac.uk
j.allotey.1@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Liverpool and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 61586
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
