Glycaemic control in labour with diabetes: GILD, a scoping study
Jones NW, Mitchell EJ, Walker KF, Ayers S, Bradshaw L, Constantinou G, Gazis T, Ojha S, Pallotti P, Petrou S, Plachcinski R, Rimmer M, Schroeder L, Thornton JG, Wakefield N
Record ID 32018014474
English
Authors' objectives:
Diabetes in pregnancy is common, affecting 5–10% of pregnant women. Poor glycaemic control in labour is associated with neonatal hypoglycaemia and other adverse outcomes for mother and baby, but tight glucose control is burdensome, intrusive and may not always be necessary. The ideal intrapartum glucose target level is unknown, traditionally ‘tight’ control (target 4–7 mmol/l) has been recommended; however, this increases the risk of maternal hypoglycaemia. To determine the feasibility of a randomised clinical trial to compare clinical and cost-effectiveness of permissive versus intensive intrapartum glycaemic control in labour in pregnancies complicated by diabetes. Diabetes in pregnancy affects 5–10% of pregnant women. For most women, this is gestational diabetes mellitus (GDM) (87.5%), but 12.5% of women have pre-existing type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). There is evidence that ‘tight’ glycaemic control in pregnancy reduces the risk of adverse outcomes for the mother and the baby. Maternal hyperglycaemia results in increased fetal insulin production because of excess placental transfer of glucose and can lead to neonatal hypoglycaemia. The ideal intrapartum glucose target level is unknown. 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 may be unnecessary, and 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 healthcare professionals (HCPs). Conversely, accepting more permissive glucose levels in the mother may be detrimental to the baby. To determine the feasibility of a randomised trial to compare the clinical and cost-effectiveness of permissive versus intensive intrapartum glycaemic control in labour in women with pregnancies complicated by diabetes.
Authors' results and conclusions:
There is significant variation in the recommended frequency of testing for gestational diabetes in labour, technologies used to test glucose levels in labour and administer insulin in type 1 diabetes mellitus, and in how neonatal hypoglycaemia is defined. Of surveyed women, 66% would be willing to participate in a future trial, with 23% unsure without further information. The service evaluation showed that once glucose testing had commenced, it was repeated after 1 hour in 18%, 2 hours in 38% and 4 hours in 45% of women. Neonatal hypoglycaemia was considered the most important neonatal outcome for a future trial, with maternal satisfaction the most important maternal outcome. The incidence of neonatal hypoglycaemia (defined as glucose
Authors' methods:
A mixed-methods study including audit of clinical guidelines from United Kingdom maternity units, online surveys of women with diabetes and healthcare professionals, service evaluation of intrapartum glycaemic care, Delphi survey and consensus meeting. Data from these work packages led to the design of a clinical trial, and qualitative interviews were held to understand acceptability of the trial. National Health Service maternity services and online input from service users. Healthcare professionals and women with type 1 or type 2 diabetes mellitus or gestational diabetes (currently pregnant or having birthed after active labour in past 3 years). Glucose levels may be poorly recorded in maternity notes and in practice tested more frequently than the study suggests. Sample sizes in some of the work packages were smaller than our pre-specified target, attrition in the Delphi survey was greater than anticipated and the study was conducted during the COVID-19 pandemic impacting results. Willingness to participate in a hypothetical trial might not translate into recruitment to a real trial. A mixed-methods scoping study of four work packages: Work package 1: Assessment of current practice determined by: review of clinical guidelines on intrapartum glycaemic control in pregnant women with diabetes and neonatal hypoglycaemia in UK maternity units survey of practice, training and experience of HCPs involved in caring for women with diabetes in labour in the UK survey of women who have/had diabetes in pregnancy to hear their views on glucose monitoring in labour and the birth outcomes that are important to them a national service evaluation of intrapartum care in pregnant women with diabetes exploring practice and adherence to clinical guidelines on maternal glycaemic control. Work package 2: Delphi survey followed by a consensus meeting to agree important components of a future trial (types of diabetes, glucose levels in control and intervention arm, frequency of monitoring, maternal and neonatal outcomes). Work package 3: Design a clinical trial of permissive versus intensive intrapartum glycaemic control in labour for women with diabetes, including consideration of an economic evaluation. Work package 4: One-to-one virtual interviews with women with diabetes who have experienced labour and HCPs who look after them to understand facilitators or barriers to conducting the trial.
Details
Project Status:
Completed
URL for project:
https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR130175
Year Published:
2025
URL for published report:
https://www.journalslibrary.nihr.ac.uk/hta/KHGD2761
URL for additional information:
English
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
England, United Kingdom
DOI:
10.3310/KHGD2761
MeSH Terms
- Pregnancy Complications
- Labor, Obstetric
- Diabetes, Gestational
- Glycemic Control
- Blood Glucose
- Infant, Newborn
- Hypoglycemia
Contact
Organisation Name:
NIHR Health Technology Assessment programme
Contact Address:
NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name:
journals.library@nihr.ac.uk
Contact Email:
journals.library@nihr.ac.uk
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.