Pre-pregnancy Care for Women with Type 2 Diabetes
The PREPARED study is an integrated primary care-based study of pre-pregnancy care to improve pregnancy outcomes in women with type 2 diabetes. It is a multi-method study of implementation, system adaptation and performance.
National audit data show that 90% of women with Type 2 Diabetes do not meet the National Institute for Health and Care Excellence (NICE) pre-pregnancy care criteria of intensifying glucose, starting high dose folic acid, and stopping teratogenic medicines. Women with Type 2 Diabetes Mellitus (T2DM) now account for over half of the pregnancies in women with pre-existing diabetes in the UK. Diabetes pregnancies without adequate preparation are high risk. Compared to women without diabetes, women with diabetes have a quadrupled risk of fetal death; and double the risks of congenital abnormality or stillbirth. Diabetes pregnancy risks can be significantly reduced with adequate pre-pregnancy care; therefore, it is imperative to improve access to this care for women living with Type 2 diabetes.
We have systematically reviewed previous interventions and worked with women and health professionals to identify novel interventions to address this care deficit. The interventions have been theoretically modelled using Capability, Opportunity, Motivation to perform a Behaviour (COM-B); the Behaviour Change Wheel (BCT) and Normalisation Process Theory (NPT). An important feature of our approach is that it is centred in primary care as part of routine diabetes management, rather than hospitals where most pre-pregnancy care is currently provided. In this study we will optimise these interventions by assessing their impact on women’s access to pre-pregnancy care (or contraception) and pregnancy outcomes.
The project aims to answer the following research questions:
- What are the optimal interventional strategies for increasing the uptake of pre-pregnancy care (PPC) and reducing unplanned pregnancies in women with Type 2 diabetes mellitus (T2DM)?
- What behavioural (woman with T2DM / health professional), and system level factors mediate the implementation of interventions to enhance the uptake of PPC in women with T2DM?
We will use a multi-method research approach based on Complex Adaptive Systems (CAS) theory to address the inherent complexity of the interventions and the implementation context (primary care). The study is comprised of four work-packages:
- integration of intervention components
- implementation and optimisation of intervention components
- intervention optimisation and implementation
- health economics
The primary output from the study will be the development of an integrated programme of interventions to improve the uptake of pre-pregnancy care for women living with Type 2 diabetes and reduce the number of adverse pregnancy outcomes in in this group.
Funding Body: National Institute for Health Research (NIHR)
Period: October 2021 - March 2024