Condition category
Pregnancy and Childbirth
Date applied
19/12/2014
Date assigned
15/01/2015
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 will be conducted. In Phase II guided interviews will be carried out with women and in Phase III, women will participate in focus group discussions. Phase IV will involve guided interviews with staff and stakeholders and participants in this phase of the research will be 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 will focus 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?
From 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

www.open.ac.uk/pcc

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.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1218514
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0015/123360/PRO-12-185-14.pdf

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

Other

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

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

The Open University
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

NIHR Health Technology Assessment

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.