Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine
Conditions
Interventions
Randomisation will be done using an online system with a randomisation scheme based on permuted blocks of random block size (sizes 4, 6 and 8), stratified by participating site. No adaptive or minimis
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a singleton, viable pregnancy between 12+0 and 15+6 weeks gestation, based on ultrasound confirmation 2. Women with at least one of the following risk factors: family history of diabetes in any one of their first degree relatives, gestational diabetes in a previous pregnancy, obesity (BMI =30 Kg/m2), minority ethnic family origin with a high prevalence of diabetes (such as South Asian, Middle Eastern and Black Caribbean), polycystic ovary syndrome, or previous macrosomic baby (birth weight >4.5 kg)
Exclusion criteria
Exclusion criteria: 1. Women known to have pre-existing type 1 or type 2 diabetes 2. Women considered to have undiagnosed type 2 diabetes, based on abnormal glycated haemoglobin (A1c) (HbA1c) levels and/or OGTT results before 15+6 weeks of pregnancy. Abnormal HbA1c levels defined as > = 48mmol/mol. Abnormal OGTT results defined as a fasting blood glucose level of > = 5.6mmol/l, or a 75g 2-hour blood glucose level of > = 7.8 mmol/l 3. Women using corticosteroids or metformin 4. Women who are not able to provide written informed consent in English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Process outcomes for the feasibility study: 1. Proportion of screened women who are eligible 2. Proportion of eligible women who are consented and randomised 3. Attrition rates at 28 weeks of pregnancy, and up to delivery 4. Adherence to treatment and to protocol 5. Deviations from the study protocol 6. Completeness of data collection 7. Determination of level of support required for the trial conduct Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of the study and intervention assessed through qualitative research interviews and questionnaires, aimed at the participants, those who refuse consent to the study, and healthcare professionals involved in the study. Women who decline trial participation are offered an optional short open-ended questionnaire to capture any reasons. Interviews with participants will be carried out in a small proportion (approx. 10-20 women), at around 20 weeks and 34 weeks of pregnancy. Interviews with 10-15 healthcare professionals are carried out towards the end of the study. Preliminary estimates of the effect of the intervention: 1. Clinical outcomes for mother and baby are collected from their medical notes at delivery 2. Laboratory outcomes of glucose metabolism tests, including an Oral Glucose Tolerance Test, are collected at the 28-week visit 3. Cost data including that of the intervention, lab tests, and clinic visits are assessed throughout the study 4. QALYs are assessed through the EQ-5D-5L questionnaire administered at baseline and delivery | — |
Countries
England, United Kingdom
Outcome results
None listed