The clinical and cost effectiveness of tight versus more relaxed glucose control around the time of birth in pregnancies complicated by gestational diabetes (GILD)
Glycaemic control in labour with diabetes
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 allocation: Tight monitoring (comparator) – glucose finger prick testing will be conducted hourly, and the acceptable blood sugar range will be 4–7 mmol/L. More relaxed monitoring (intervention) – glucose finger prick testing will be conducted every 2–4 hours, and the acceptable blood sugar range will be 4–10 mmol/L. Glucose testing by finger prick testing will commence from the point of: i) admission in either spontaneous established labour, or ii) following artificial rupture of membranes or onset of regular contractions following induction of labour, or iii) admission for elective caesarean section Data on the birth, maternal health outcomes and neonatal health outcomes will be collected between admission for birth and hospital discharge. At the time of discharge, women/birthing people will complete questionnaires about their birth experience and quality of life. A follow-up questionnaire will also be completed at 6 weeks after birth and an economic evaluation will be undertaken. To determine acceptability of more relaxed glucose control, some women/birthing people and healthcare practitioners will be interviewed. Qualitative sub-study Women/birthing people: Approximately 20 women/birthing people will be purposively sampled via a pre-defined sampling matrix. At the point of consent for the main trial, women/birthing people can give optional consent to be contacted about the qualitative sub-study. At around 6 weeks post-birth the women/birthing people will be provided with an information sheet about the qualitative sub-study and if they agree to take part an interview will be arranged for between 6 and 12 weeks post-birth. Verbal consent will be collected and recorded by the researcher before the start of the interview. Interviews will last around 30–45 minutes and will
1. Women/birthing people with gestational diabetes mellitus 2. Aged 16 years or over (or < 16 years if deemed Gillick competent). 3. Singleton pregnancy 4. Able to provide informed consent 5. Planned birth >=37 weeks gestation
1. Known lethal fetal anomaly 2. At time of consent, known clinical indication to recommend birth < 37 weeks