Glycaemic control in labour with diabetes (GILD Trial)

The clinical and cost effectiveness of tight versus more relaxed glucose control around the time of birth in pregnancies complicated by gestational diabetes (GILD)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13019598

Enrollment

1630

Registered

2025-07-16

Start date

2025-09-23

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycaemic control in labour with diabetes Pregnancy and Childbirth

Interventions

Main study When the woman/birthing person comes into hospital to birth their baby, the clinical team providing intrapartum care will follow the glucose monitoring strategy as per randomised allocatio

Eligibility

Sex/Gender

Female

Age

14 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Women/birthing people with gestational diabetes mellitus 2. Aged 16 years or over (or =37 weeks gestation

Exclusion criteria

Exclusion criteria: 1. Known lethal fetal anomaly 2. At time of consent, known clinical indication to recommend birth < 37 weeks

Design outcomes

Primary

Measure	Time frame
Co-Primary outcomes: 1. Neonatal hypoglycaemia, as defined by a blood glucose level of <2 mmol/L at any time and/or a single value of <2.5 mmol/L in a baby with abnormal clinical signs. Tested using a blood gas analyser, between birth and neonatal discharge after birth. 2. Neonatal unit admission (any level; 1-3) at any point between birth and neonatal discharge after birth measured using patient records.	—

Measure

Time frame

Co-Primary outcomes: 1. Neonatal hypoglycaemia, as defined by a blood glucose level of <2 mmol/L at any time and/or a single value of <2.5 mmol/L in a baby with abnormal clinical signs. Tested using a blood gas analyser, between birth and neonatal discharge after birth. 2. Neonatal unit admission (any level; 1-3) at any point between birth and neonatal discharge after birth measured using patient records.

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Secondary

Measure	Time frame
Measured using patient records (unless noted otherwise): Secondary outcomes (neonatal): 1. Outcome of birth, defined as live/stillbirth. 2. Symptomatic neonatal hypoglycaemia, measured on a ‘symptoms checklist’ between birth and neonatal discharge after birth. 3. Treatment for neonatal hypoglycaemia between birth and neonatal discharge after birth. 4. Duration of neonatal unit admission between birth and neonatal discharge after birth. 5. Neonatal hypothermia, defined as any episode <36.5C between birth and neonatal discharge after birth. 6. Hypoxic ischaemic encephalopathy (HIE) requiring active therapeutic hypothermia between birth and neonatal discharge after birth. 7. Neonatal death less than or equal to 28 days since birth. 8. Breastfeeding, captured in the CRF between birth and neonatal discharge, and a participant-completed questionnaire at 6 weeks post-birth. Secondary outcomes (maternal) 9. Maternal hypoglycaemia defined as blood glucose < 3.5mmol/L, measured using capillary blood glucose values during admission for birth. 10. Maternal admission to critical care, between admission for birth and maternal discharge after birth. 11. Postnatal depression. Measured using the Edinburgh Postnatal Questionnaire, completed by the participant 6 weeks after birth. Secondary outcomes (treatment acceptability and adherence) 12. Maternal satisfaction with childbirth experience. Measured by Birth Satisfaction Scale Revied (validated questionnaire) and selected questions from the Childbirth Experience Questionnaire v2 6 weeks after birth. 13. Maternal satisfaction with blood glucose monitoring strategy. Measured using a study-specific questionnaire at maternal discharge after birth. 14. Woman/birthing person able to eat/drink what they want around the time of birth. Measured via participant-completed questionnaire at maternal discharge after birth. Secondary outcomes (cost effectiveness) 15. Maternal health-related quality of life, measured using the EQ-5D-5L at baseline	—

Measure

Time frame

Measured using patient records (unless noted otherwise): Secondary outcomes (neonatal): 1. Outcome of birth, defined as live/stillbirth. 2. Symptomatic neonatal hypoglycaemia, measured on a ‘symptoms checklist’ between birth and neonatal discharge after birth. 3. Treatment for neonatal hypoglycaemia between birth and neonatal discharge after birth. 4. Duration of neonatal unit admission between birth and neonatal discharge after birth. 5. Neonatal hypothermia, defined as any episode <36.5C between birth and neonatal discharge after birth. 6. Hypoxic ischaemic encephalopathy (HIE) requiring active therapeutic hypothermia between birth and neonatal discharge after birth. 7. Neonatal death less than or equal to 28 days since birth. 8. Breastfeeding, captured in the CRF between birth and neonatal discharge, and a participant-completed questionnaire at 6 weeks post-birth. Secondary outcomes (maternal) 9. Maternal hypoglycaemia defined as blood glucose < 3.5mmol/L, measured using capillary blood glucose values during admission for birth. 10. Maternal admission to critical care, between admission for birth and maternal discharge after birth. 11. Postnatal depression. Measured using the Edinburgh Postnatal Questionnaire, completed by the participant 6 weeks after birth. Secondary outcomes (treatment acceptability and adherence) 12. Maternal satisfaction with childbirth experience. Measured by Birth Satisfaction Scale Revied (validated questionnaire) and selected questions from the Childbirth Experience Questionnaire v2 6 weeks after birth. 13. Maternal satisfaction with blood glucose monitoring strategy. Measured using a study-specific questionnaire at maternal discharge after birth. 14. Woman/birthing person able to eat/drink what they want around the time of birth. Measured via participant-completed questionnaire at maternal discharge after birth. Secondary outcomes (cost effectiveness) 15. Maternal health-related quality of life, measured using the EQ-5D-5L at baseline

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Countries

England, United Kingdom, Wales

Contacts

Public ContactSamantha Harrison

GILD@nottingham.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026