Award Title: Glycaemic control in labour with Diabetes (GILD)
Funder: Department of Health and Social Care

Abstract: Women with diabetes in pregnancy have their blood sugar levels closely monitored during labour in order to minimise the effects of high sugar on their baby after birth. High blood sugar in the mother can cause low blood sugar in the baby. However, this monitoring is intrusive and expensive. New evidence suggests that it may not be as important for preventing problems in the baby as previously thought._x000D_
A research study is planned but, before this, we want to find out from doctors and midwives:_x000D_
•	Exactly how they care for pregnant women with diabetes in labour_x000D_
•	Exactly how common it is to find low blood sugar levels in babies_x000D_
•	What complications it causes for babies and mothers in practice_x000D_
•	What types of sugar monitoring in labour should be tested in future research_x000D_
•	How acceptable such research would be to staff and pregnant women._x000D_
This is an important issue as diabetes in pregnancy is increasing in the UK. It currently affects 5% of all pregnant women. Most have gestational diabetes, which develops during pregnancy and goes away after birth, with the rest having diabetes before they get pregnant._x000D_
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The risk we are focusing upon is mother’s high blood sugar leading to low blood sugars in their babies. This happens when the baby in the womb produces more insulin to help process the high levels of sugar transferred across the placenta from their mother. At birth, the umbilical cord is cut and this high sugar supply stops suddenly. The baby struggles to cope with this change in their sugar levels especially as their high insulin levels take time to drop to normal. This can potentially be avoided by regular feeding but blood sugar can fall despite feeding and babies may suffer brain damage. The baby’s blood sugar has to be carefully tested to prevent this. Additionally, by trying hard to ensure mothers’ sugars do not become elevated there is a risk of low blood sugar that can cause harm to the mother if this is not recognised and treated._x000D_
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Our research plan is to:_x000D_
•	Ask hospitals throughout the UK about their local guidelines on monitoring blood glucose levels in labour and the newborn baby_x000D_
•	Survey hospital staff to find out what blood sugar monitoring systems (e.g. finger prick test or electronic sensor devices) they use and what training is needed to improve care_x000D_
•	Survey women with recent experience of diabetes in pregnancy to hear their views on monitoring in labour and the birth outcomes which are important to them_x000D_
•	Conduct an audit in UK hospitals to determine how often they see low blood sugar in both mothers with diabetes in labour and in their newborn babies and what problems are associated with this._x000D_
Our goal is to design a research study comparing blood sugar monitoring strategies in labour for women with diabetes. We will then ask women, experienced doctors and midwives during telephone interviews whether theoretically they would be willing to be involved in such a study, and what they feel the barriers would be._x000D_
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We will also recruit women who have experienced diabetes in labour to be members of an advisory group to the project. We want this research to be directly relevant to improving women’s experience of maternity care, and be acceptable to families we are recruiting to answer questionnaires and take part in interviews. We will consult our advisory group on the wording of study information, questionnaires, analysing the data we collect, writing up the results and sharing them with different groups.

Lay Abstract: RESEARCH QUESTION_x000D_
Is it feasible to run a trial to assess the clinical and cost-effectiveness of permissive versus intensive intrapartum glycaemic control in women with pregnancies complicated by diabetes?_x000D_
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BACKGROUND_x000D_
Diabetes in pregnancy affects at least 5% of pregnant women. For most women this is gestational diabetes (GDM) (87.5%), but 12.5% women have pre-existing diabetes. There is evidence that ‘tight’ glycaemic control in pregnancy reduces the risk of adverse outcomes for the mother and the baby._x000D_
Traditionally ‘tight’ glucose control (target 4-7 mmol/L) is recommended in labour. Treatment with intravenous insulin may be needed during labour to maintain ‘tight’ control, however, this increases the risk of maternal hypoglycaemia in labour, which carries a risk to the mother. Hourly intrapartum testing is also intrusive for women and time consuming for health care practitioners. Conversely, accepting more permissive glucose levels in the mother may be detrimental to the baby. Maternal hyperglycaemia results in increased fetal insulin production because of excess placental transfer of glucose and can lead to neonatal hypoglycaemia._x000D_
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AIMS AND OBJECTIVES_x000D_
To determine current practices in intrapartum glucose control and decide on how best to conduct a future trial in all forms of diabetes._x000D_
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METHODS_x000D_
Work package 1_x000D_
- Conduct three national cross-sectional surveys of:_x000D_
a)	Current UK clinical guidelines on intrapartum care in pregnant women with diabetes and neonatal hypoglycaemia in the babies_x000D_
b)	Current practice, training and experience of midwifery staff and other health care professionals in intrapartum glycaemic control in the UK _x000D_
c)	Women who have/had diabetes in pregnancy to hear their views on glucose monitoring in labour and the birth outcomes which are important to them_x000D_
- Conduct a national audit of intrapartum care in pregnant women with diabetes exploring current practice and adherence to clinical guidelines on maternal glycaemic control._x000D_
Work package 2_x000D_
To reach consensus by a Delphi survey on the most important clinical components of a future trial of permissive versus intensive intrapartum glycaemic control (types of diabetes to be included, glucose levels, frequency of monitoring, outcomes) in pregnancies with diabetes._x000D_
Work package 3_x000D_
Design a clinical trial comparing blood sugar monitoring strategies in labour for women with diabetes. _x000D_
Work package 4_x000D_
Understand facilitators or barriers to conducting a trial comparing permissive to intensive glycaemic control for women with diabetes._x000D_
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TIMELINES FOR DELIVERY_x000D_
We will deliver this scoping study in 24 months._x000D_
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ANTICIPATED IMPACT AND DISSEMINATION_x000D_
The results of this study will be essential for the planning of any future randomised trial in this area.  It will increase our understanding of the current practice of intrapartum care for women with diabetes, the prevalence of maternal and neonatal hypoglycaemia and the frequency of complications arising from it. It will increase awareness of the problem amongst health care professionals and parents. It will highlight training deficiencies in this area. The research findings will be disseminated via a published HTA monograph, research papers published in high-impact peer review journals and presentation at medical and midwifery conferences locally, nationally and internationally. They will also be made available via Diabetes UK and Gestational Diabetes, alongside plain English summaries.

Research Activity Codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health Categories: METABOLIC AND ENDOCRINE;REPRODUCTIVE HEALTH AND CHILDBIRTH