Pre-pregnancy care for women with type 2 diabetes
| ISRCTN | ISRCTN47576591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47576591 |
| IRAS number | 297153 |
| Secondary identifying numbers | CPMS 51180, IRAS 297153 |
- Submission date
- 21/01/2022
- Registration date
- 08/02/2022
- Last edited
- 30/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
This study will assess new ways to improve access to pre-pregnancy care for women living with Type 2 diabetes and reduce pregnancy complications and costs. Women with Type 2 diabetes account for 50% of pregnancies in those with established diabetes. Diabetes pregnancies are risky for both mother and baby, especially if unplanned. If the mother has high sugar levels or is taking medications that are unsafe in pregnancy, the baby may be harmed. The risk of a miscarriage is four times higher, and the risks of birth defects and stillbirths are doubled compared to those without diabetes. Half of these pregnancies have caesarean deliveries; a quarter of the women have large babies, and many babies require special care. Such outcomes are distressing for mothers and result in higher care costs. Most women with Type 2 diabetes do not know these risks. Only 10% of women with Type 2 diabetes receive pre-pregnancy care, which reduces risks by improving blood sugar levels, stopping harmful medications and giving high-dose folic acid. Therefore, improving access to pre-pregnancy care for women with Type 2 diabetes is a high priority. The researchers reviewed previous studies on pre-pregnancy care uptake and talked to women and health professionals. A key barrier is the location of pre-pregnancy care in hospitals, rather than in primary care where most women with Type 2 diabetes are seen. Pre-pregnancy care access should improve if it is delivered in a primary care setting.
Who can participate?
Women aged 18-45 years living with Type 2 diabetes and attending one of the participating GP practices in Lambeth and Southwark
What does the study involve?
The researchers have developed a package of primary care-based interventions to ensure that women receive regular reproductive support. The interventions include:
1. A clear set of instructions about what care women should receive
2. Training for health professionals who usually care for women with Type 2 diabetes including clear guidance on what to do and when
3. Information for women
4. Recording information about the health of the women and baby at birth (in those who become pregnant) to see if the help made a difference
The researchers will assess the impact of the intervention by doing an audit of pre-pregnancy care uptake and pregnancy outcomes at regular intervals in 30 general practices in areas with high deprivation and with mixed ethnic groups. Using multiple types of data collection, the researchers will audit the uptake of pre-pregnancy care and ask women and health professionals about their experiences in the study. As the study progresses, they will identify how to improve the interventions and how best to implement the interventions in the NHS. They will hold an event with women, health professionals and managers to share what we have learnt and identify if there are any further changes needed, and to plan how the package of care could be used by others who care for women.
What are the possible benefits and risks of participating?
At the end of the study, the researchers will share their findings widely (including with patients). If successful they will make the interventions and an implementation plan available to the NHS, so as to improve pregnancy outcomes for this growing population. The benefits for participating GP practices will be exposure to supportive strategies and tools to embed reproductive healthcare into the routine care for women living with Type 2 diabetes. Women living with Type 2 diabetes who participate will have the opportunity to share their experiences and make recommendations on future iterations of the study interventions.
Where is the study run from?
King’s College London (UK)
When is the study starting and how long is it expected to run for?
October 2021 to December 2024
Who is funding the study?
National Institute of Health Research (NIHR) (UK)
Who is the main contact?
1. Prof Angus Forbes, angus.forbes@kcl.ac.uk
2. Dr Rita Forde, rita.forde@kcl.ac.uk
Contact information
Principal Investigator
Faculty of Nursing, Midwifery and Palliative Care
King's College London
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
| Phone | +44 (0)2078483367 |
|---|---|
| angus.forbes@kcl.ac.uk |
Study information
| Study design | Non-randomized; Both; Design type: Process of Care, Education or Self-Management, Complex Intervention, Management of Care, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An integrated primary care-based programme of pre-pregnancy care to improve pregnancy outcomes in women with type 2 diabetes: a multi-method study of implementation, system adaptation and performance. |
| Study acronym | PREPARED |
| Study objectives | 1. What are the optimal interventional strategies for increasing the uptake of pre-pregnancy care and reducing unplanned pregnancies in women with type 2 diabetes mellitus? 2. What behavioural (woman with type 2 diabetes/health professional), and system-level factors mediate the implementation of interventions to enhance the uptake of pre-pregnancy care in women with type 2 diabetes? |
| Ethics approval(s) | Approved 23/12/2021, Camden and King's Cross London Research Ethics Committee (address: not available; +44 (0)207 104 8086, +44 (0)207 104 8068, +44 (0)207 104 8233; camdenandkingscross.rec@hra.nhs.uk), REC ref: 21/LO/0823 |
| Health condition(s) or problem(s) studied | Pre-pregnancy care for women living with type 2 diabetes |
| Intervention | The intervention will include adjusting GP practice electronic records to promote the identification of and treatment plans for women of reproductive age living with type 2 diabetes. It will also include education support for healthcare professionals in primary care and resources for women living with type 2 diabetes. The researchers will use repeat measures to assess the utility of these strategies and iterative amend these to optimise pre-pregnancy care for this group. There will be an 18-month observation period during which the researchers will iteratively refine the intervention components – strategies to embed pre-pregnancy care into routine care. |
| Intervention type | Other |
| Primary outcome measure | Extracted in anonymised format from a template embedded into the electronic records within each of the participating GP practices at baseline and quarterly during the observation period at study months 10, 14, 18 and 22: 1. HbA1c testing and results (number of patients ≤48 mmol/mol [6.5%]) 2. Number of patients commencing on folic acid 5 mg 3. Number of patients ceasing potentially teratogenic therapies |
| Secondary outcome measures | Extracted in anonymised format from a template embedded into the electronic records within each of the participating GP practices at baseline and quarterly during the observation period at study months 10, 14, 18 and 22: 1. Number of patients having a reproductive review and care plan instigated 2. Number of patients engaged in the pre-pregnancy care pathway - referred to intermediate or hospital diabetes teams 3. Number of patients instigated on contraception |
| Overall study start date | 01/10/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 750; UK Sample Size: 750 |
| Key inclusion criteria | 1. Women living with Type 2 diabetes aged 18-45 years attending one of the participating GP practices 2. GP practice participation is limited to those in Lambeth and Southwark with more than 25 women meeting the eligibility criteria registered to the practice. |
| Key exclusion criteria | 1. Women who do not have Type 2 diabetes or are not attending one of the participating GP practices 2. GP practice participation in Lambeth and Southwark with less than 25 women meeting the eligibility criteria registered to the practice |
| Date of first enrolment | 14/02/2022 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 8WA
United Kingdom
Sponsor information
University/education
King's College London
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)2078483224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
R&D Department
16th Floor, Tower Wing
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)20 7188 7188 |
|---|---|
| R&D@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The researchers plan to publish the protocol and will disseminate their findings widely through academic journals; NHS and service-user networks; and through the study website and social media. A protocol manuscript has been submitted for review. The researchers have a strong Patient and Public Involvement (PPI) and advisory group with patients, health professionals and representatives from women’s and patient organisations. The PPI group guided the design of this study and will be part of the study advisory board which will be co-led by the patient co-applicant. |
| IPD sharing plan | Participant level data will not be publicly available as the is the potential to progress to a larger trial and these data will be reserved to support this. All data will be stored securely and anonymously at King’s College London. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/04/2022 | 18/01/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/12/2024: The intention to publish date was changed from 31/03/2025 to 31/06/2025.
01/05/2024: The recruitment end date and overall study end date were changed from 31/03/2024 to 31/12/2024. Study website added.
17/10/2023: The recruitment end date was changed from 31/10/2023 to 31/03/2024.
18/01/2023: Publication reference added.
03/02/2022: Trial's existence confirmed by the NIHR.
