None listed
Conditions
Brief summary
We hypothesise that in women with HbA1c levels in the pre-diabetes range, that early intervention, including blood glucose monitoring and optimisation of blood glucose levels through dietary measures and medication as required, will reduce preeclampsia, preterm birth, neonatal morbidity and mortality without causing harm, compared with lifestyle advice and screening for gestational diabetes at 24-28 weeks’ gestation. This study is important to enable clinicians to decide how to manage women with early pregnancy HbA1c levels in the pre-diabetes range, which is especially relevant now that national and international groups and societies are endorsing the use of HbA1c as a screening test in early pregnancy. This is a feasibility study for the main randomised control trial.
Interventions
Group B – Intervention group
Attend a diabetes in pregnancy clinic, from before 14 weeks' gestation, in combination with standard care from their usual lead maternity carer (community midwife or obstetrician).
Commence blood sugar monitoring four to six times daily, fasting and one hour after all meals, using a finger prick and handheld glucose monitoring device.
Attend one 1-hr group lifestyle education session (dietary, weight-gain and exercise advice) with our clinic dietitian. Have on
Group B – Intervention group Attend a diabetes in pregnancy clinic, from before 14 weeks' gestation, in combination with standard care from their usual lead maternity carer (community midwife or obstetrician). Commence blood sugar monitoring four to six times daily, fasting and one hour after all meals, using a finger prick and handheld glucose monitoring device. Attend one 1-hr group lifestyle education session (dietary, weight-gain and exercise advice) with our clinic dietitian. Have ongoing individual lifestyle education (diet and exercise) with a clinic dietitian at a 20 minute clinic appointment every 4 weeks, written dietary advice and examples of meal plans will be provided. Medication, as required, will be prescibed by a clinic physician in order to maintain blood glucose levels within the usual targets for pregnancy. This group will attend clinic appointments approximately once per month throughout pregnancy. Adherence to treatment will be monitored through participant blood glucose diaries, downloading data from glucometers, recording patient weight at clinic appointments, dietary and exercise questionnaire at trial entry, 36 weeks' gestation and at three months postpartum. Group B will not perform an OGTT in pregnancy.
Sponsors
Ruth Hughes
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: Women with an HbA1c level of 41-46mmol/mol and who are <14 weeks’ gestation with an ongoing pregnancy.
Exclusion criteria
Exclusion criteria: Women with HbA1c levels greater than or equal to 47mmol/mol. Women with known diabetes. Women carrying a fetus with a known lethal congenital anomaly and / or an abnormal karyotype / chromosomal abnormality. Women planning to terminate the pregnancy. Women taking metformin to manage pre-diabetes or polycystic ovarian syndrome will be excluded from the study and referred to the local antenatal diabetes clinic, or be advised to have an early 75g oral glucose tolerance test (OGTT) depending on local policy.
Outcome results
None listed