Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Recruitment and consent
Previous:
Research midwives will screen the medical records of women who are pregnant and due for their first scan appointment at the hospital, to identify women who fulfil th
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/10/2021: 1. Pregnant women at <20 weeks’ gestation 2. 18 years of age and above 3. BMI =30 kg/m² at baseline assessment 4. Planned antenatal care at the study setting until delivery 5. Women who are able to provide written informed consent Previous inclusion criteria: 1. Pregnant women at <15 weeks’ gestation 2. 18 years of age and above 3. BMI =30 kg/m² at baseline assessment 4. Planned antenatal care at the study setting until delivery 5. Women who are able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Severe congenital anomaly (confirmed by ultrasound) 2. Planned termination of pregnancy 3. Pre-pregnancy diagnosis of diabetes (type 1 or type 2), renal disease, severe liver disease, organ transplant, cardiac failure (Grade II New York Heart Association, and more severe), severe neurological disorder (including epilepsy), severe psychiatric disease requiring in-patient admission 4. A fasting plasma glucose level of 5.6 mmol/l or above or a 2-hour plasma glucose level of 7.8 mmol/l or above, at the baseline OGTT 5. Taking metformin, as it affects glycaemia 6. History or suspicion of, eating disorder 7. Hyperemesis gravidarum 8. Women unable to understand spoken and written English 9. Previous bariatric surgery 10. Women participating in other intervention research studies that may affect their weight, health behaviours or blood glucose control 11. Any other significant disease or disorder which, in the opinion of the Chief Investigator or clinical co-investigators, may either put the participants at risk because of participation in the trial, or may influence the result of the study, or the participant’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility progression criteria: 1. Adoption of the intervention: mean reduction in total carbohydrate intake per day in the intervention group, assessed by dietary composition analysis at the baseline visit (<20 weeks’ gestation) and at the follow-up visit (24-28 weeks’ gestation) 2. Retention rate: proportion of participants from whom OGTT data is available at the follow-up visit, documented during the follow-up visit at 24-28 weeks’ gestation Updated 31/05/2022: the baseline visit was changed from “<15 weeks’ gestation” to “<20 weeks’ gestation”. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. Change in fasting plasma glucose and 1h and 2h post glucose drink blood glucose, assessed with analysis of blood samples collected as part of an Oral Glucose Tolerance Test (OGTT) at the baseline visit ( 4500 g) (INTERGROWTH standards); Rates of large-for-gestational-age (LGA) infant (>90th percentile) (INTERGROWTH standards); rates of small-for-gestational-age (SGA) infant (<10th percentile) (INTERGROWTH standards); Neonatal Intensive Care Unit (NICU) admission; Shoulder dystocia/birth trauma; Neonatal hypoglycaemia requiring intravenous glucose; Neonatal hyper-bilirubinaemia requiring phototherapy 5. EQ-5D (EuroQol) questionnaire score, assessed through EuroQol questionnaire completion at the baseline visit (<20 weeks’ gestation) and at the follow-up visit (24-28 weeks’ gestation) 6. Acceptability and overall experience of the intervention, assessed through qualitative interviews with participants from the intervention group, any time after the follow-up visit at 24-28 weeks’ gestation and delivery Updated 31/05/2022: the baseline visit was changed from “<15 weeks’ gestation” to “<20 weeks’ gestation”. | — |
Countries
England, United Kingdom
Outcome results
None listed