Gestational diabetes, obesity in pregnancy Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
Current interventions as of 16/09/2014:
Once women are included in the study, they will be randomised into one of two groups: exercise intervention or non-intervention (standard antenatal care).
The
Sponsors
Coombe Women and Infants University Hospital (Ireland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant 2. BMI more 29.9 kg/m2 (obese) 3. Over 18 years of age 4. Fluent in English 5. Able to give written informed consent 6. Willing to be assigned to any of the intervention groups
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 16/09/2014: 1. BMI less than 29.9 kg/m2 2. Gestation >17 weeks gestation 3. Multiple pregnancy 4. Pre-existing diabetes mellitus 5. Hypertension (systolic pressure >160 mmHg and/or diastolic pressure >100 mmHg) or requiring antihypertensive medication 6. Alcohol abuse (i.e., two glasses alcohol or more per day) 7. Drug abuse (except for incidental analgesic agents) 8. Use of medication that affects insulin secretion or insulin sensitivity (antiviral, corticosteroids, antihypertensive drugs, all medication will be discussed) 9. Serious cardiorespiratory disorders 10. Hepatic or renal (serum creatinine >100 µmol/l) impairment 11. Systemic lupus erythematosus 12. Haematological disorders 13. Thalassaemia 14. Coeliac disease 15. Current psychosis 16. Malignant disease 17. Contraindications outlined on the parmed-x form Previous exclusion criteria: 1. BMI less than 29.9 kg/m2 2. Multiple pregnancy 3. Pre-existing (gestational) diabetes mellitus 4. Hypertension (systolic pressure >160 mmHg and/or diastolic pressure >100 mmHg) or requiring antihypertensive medication 5. Alcohol abuse (i.e., two glasses alcohol or more per day) 6. Drug abuse (except for incidental analgesic agents) 7. Use of medication that affects insulin secretion or insulin sensitivity (antiviral, corticosteroids, antihypertensive drugs, all medication will be discussed) 8. Serious cardiorespiratory disorders 9. Hepatic or renal (serum creatinine >100 µmol/l) impairment 10. Systemic lupus erythematosus 11. Haematological disorders 12. Thalassaemia 13. Coeliac disease 14. Thyroid disease 15. Current psychosis 16. Malignant disease 17. Contraindications outlined on the parmed-x form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 16/09/2014: The primary purpose of this randomised controlled trial (RCT) is to determine if an intensive, supervised, established, sustained exercise intervention from early in the second trimester onwards would improve maternal glycaemic control in obese women. Specifically, we hypothesise that the exercise intervention will significantly decrease the mean maternal fasting glucose at 24-28 weeks gestation by 0.4 mmol per litre at the time of a standard 75 g OGTT to screen for gestational diabetes mellitus (HAPO, NEJM 2008) when compared with the mean maternal fasting glucose of the non-intervention group. Previous primary outcome measures: The primary purpose of this randomised controlled trial (RCT) is to determine if an intensive, supervised, established, sustained exercise intervention from early in the second trimester onwards would improve maternal glycaemic control in obese women. Specifically, we hypothesise that the exercise intervention will significantly decrease the mean maternal fasting glucose at 28 weeks gestation by 0.4 mmol per litre at the time of a standard 75 g OGTT to screen for gestational diabetes mellitus (HAPO, NEJM 2008) when compared with the mean maternal fasting glucose of the non-intervention group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/09/2014: The secondary objectives of the RCT will be to determine if the exercise programme in the intervention arm will improve significantly, when compared with non-intervention: 1. Gestational weight gain (GWG) in women at 24-28 weeks and 35-38 weeks gestation 2. Maternal weight retention at 6 weeks postpartum 3. Maternal body composition at 24-28 weeks and 35-38 weeks gestation and at 6 weeks postpartum 4. Objectively measured physical activity as measured by the IPAQ questionnaire at 24-28 and 35-38 weeks gestation and 6 weeks postpartum 5. Objectively measured physical activity as measured by RT6 accelerometer at 24-28 and 35-38 weeks gestation and at 6 weeks postpartum 6. Strength at 6 weeks postpartum 7. Fitness at 6 weeks postpartum 8. The number of abnormal OGTTs at 24-28 weeks gestation 9. The number of abnormal fasting lipid profiles 10. Insulin resistance measured at 24-28 weeks gestation 11. The inflammatory marker C-reactive protein as measured at 24-28 and 25-38 weeks gestation and 6 weeks postnatally 12. The white cell count as measured at 24-28 and 35-38 weeks gestation and at 6 weeks postpartum 13. Choice of food intake, as recorded on SLAN questionnaires at 24-28 and 35-38 weeks gestation and at 6 weeks postpartum 14. Quality of food intake as recorded on 7-day food and lifestyle diaries at 12-14, 24-28 and 35-38 weeks gestation and 6 weeks postpartum 15. Quality of life as measured by the EuroQOL questionnaire 6 weeks postpartum 16. The number of obstetric interventions (a composite measure of induction of labour and operative delivery) 17. The number of women requiring induction of labour 18. The number of women delivering before 37 weeks gestation 19. The number of women delivering after their expected due date 20. The number of caesarean deliveries 21. The length of the second stage of labour in minutes 22. Estimated fetal weight at 24-28 and 35-38 weeks gestation 23. Ultraso | — |
Countries
Ireland
Outcome results
None listed