Plain English Summary
Background and study aims
Diabetes is a global public health problem and one of the most common medical complications in pregnancy. Rates of diabetes in pregnancy are rapidly increasing, especially due to the projected growth in the number of women who are obese or overweight. Obesity can increase the risk of getting type 2 diabetes but both forms of pre-existing diabetes – type 1 and type 2 – can lead to serious complications. These risks to health can be modified and pre-conception care is known to make a difference. However, the uptake of pre-conception care is often low and it remains unclear how this can be improved. This study aims to review the existing literature in the field and conduct qualitative work to understand why women with pre-existing diabetes do, or do not, access pre-conception care, focusing specifically on the factors that facilitate or discourage uptake. A further objective is to investigate the views of staff and stakeholders at the frontline of service provision in order to explore their views.
Who can participate?
White British women and Pakistani women (whose preferred language is Urdu), with pre-existing Type 1 and Type 2 diabetes of childbearing age (between 16 and 45 years). Staff and stakeholders who are involved in caring for women with diabetes of reproductive age and/or the delivery of pre-conception care.
What does the study involve?
The study involves five phases. In Phase I a comprehensive review of the existing descriptive literature is conducted. In Phase II guided interviews are carried out with women and in Phase III, women participate in focus group discussions. Phase IV involves guided interviews with staff and stakeholders and participants in this phase of the study are invited to reflect on the views of service users, ensuring that the views of service users are at the centre of the project. Phase IV focuses on writing the project report and disseminating the findings of the project to maximise the potential impact of this work.
What are the possible benefits and risks of participating?
The great potential of this project is to improve women’s health outcomes by increasing the uptake of pre-conception care through a better understanding of the factors influencing uptake. The risks involved in participating are minimal, although there is a small risk that participants may find questions upsetting or intrusive. In relation to possible benefits of participating, participants may find the information available on the study website useful and will be provided with a summary of the major findings of the project.
Where is the study run from?
Sandwell and Birmingham CCG and Heartlands Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2014 to July 2016
Who is funding the study?
The Open University (UK)
Who is the main contact?
Dr Sarah Earle
sarah.earle@open.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Sarah Earle
ORCID ID
http://orcid.org/0000-0003-2810-5659
Contact details
Horlock Building
Walton Hall
The Open University
Milton Keynes
MK7 6AA
United Kingdom
+44 (0)1908 654 260
sarah.earle@open.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 12/185/14
Study information
Scientific title
Pre-conception care for women with type 1 or type 2 diabetes: what are the facilitators and barriers to uptake?
Acronym
PCC
Study hypothesis
1. To systematically review the descriptive research on pre-conception care for women with diabetes of childbearing age, and establish themes and gaps in knowledge.
2. Through qualitative work, identify views on the provision of, and facilitators and barriers to the uptake of pre-conception care.
This research study aims to gain a better understanding of the views of White British women and Pakistani women of childbearing age who have accessed pre-conception care in the last 3 years and those that have not. They are looking at what the facilitators and barriers in the uptake of pre-conception care are.
Ethics approval
South Central Berkshire NRES Committee, 05/03/2015, ref: 15/SC/0026
Study design
Observational multicentre study
Primary study design
Observational
Secondary study design
Qualitative study
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Diabetes in pregnancy
Intervention
The proposed study adopts a qualitative mixed-methods approach designed to explore the two key research questions, namely, to understand why women with diabetes of childbearing age do/do not access pre-conception care, and to elicit the views of staff and stakeholders on this and on future provision of this service. A better understanding of the views of women, and of the relevant staff and stakeholders, is needed in order to inform service design and delivery. The use of qualitative methods is best placed to explore views on the provision of, and the facilitators and barriers to, the uptake of pre-conception care. A qualitative mixed-methods design will be used to ensure that the views of service users are at the centre of the research. This design will also allow meaningful and nuanced data to emerge that reflects the views of services users, staff and stakeholders and can be used to understand how pre-conception care could be provided to optimise uptake and outcomes.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. To understand why women with diabetes of childbearing age do, or do not, access pre-conception care, with a view to informing services
2. To investigate the views of staff and stakeholders to explore existing and future provision of pre-conception care
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/08/2014
Overall trial end date
31/07/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. White British women and Pakistani women (whose preferred language is Urdu), with pre-existing Type 1 and Type 2 diabetes of childbearing age between 16 and 45 years inclusive
2. Staff and stakeholders who are involved in caring for women with diabetes of reproductive age and/or the delivery of pre-conception care
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
40 women and 20 staff/stakeholders
Participant exclusion criteria
1. Women with diagnosed mental health issues
2. Women <16 and >45 years
Recruitment start date
30/01/2015
Recruitment end date
31/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sandwell and Birmingham CCG
Kingston House
438-450 High Street
West Bromwich
Birmingham
B70 9LD
United Kingdom
Trial participating centre
Diabetes and Endocrinology Centre
Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom
Sponsor information
Organisation
The Open University
Sponsor details
Walton Hall
Milton Keynes
MK7 6AA
United Kingdom
+44 (0)1908 655850
graham.p.mitchell@open.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a repository (https://figshare.com/s/d53346337f0db8e2f282) and available on request from Dr Sarah Earle
(sarah.earle@open.ac.uk).
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28398196