Gestational diabetes mellitus Pregnancy and Childbirth Gestational diabetes mellitus
Conditions
Interventions
Current interventions as of 17/06/2020:
Participants will be randomly allocated to either the intervention or the control group.
Participants in the intervention group will be further randomised to r
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/05/2020: 1. Aged 18 years or older 2. Gestational age = 16 weeks 3. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM): 3.1. Booking BMI = 25kg/m² 3.2. Age = 25 years 3.3. First-degree relative with diabetes 3.4. Previous pregnancy with GDM 3.5. Previous pregnancy with large baby (= 3.5kg) 3.6. Previous pregnancy with pre-eclampsia/eclampsia 3.7. History of PCOD/impaired fasting glucose) 4. Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre-eclampsia) _____ Previous inclusion criteria: 1. Aged 18 years or older 2. Pregnant females 3. Gestational age >16 weeks 4. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM): 4.1. BMI =25 kg/m² (for Indian women, BMI =23 kg/m² 4.2. First-degree relative with diabetes 4.3. Previous pregnancy with GDM 4.4. Previous pregnancy with a large baby (=3.5 kg) 4.5. Previous pregnancy with pre-eclampsia/eclampsia 4.6. History of polycystic ovary disease (PCOD) or impaired fasting glucose 5. Not currently on any medications (excluding iron or folic acid supplements)
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 07/05/2020: 1. GDM diagnosed prior to screening visit based on IADPSG criteria or documented raised HbA1C, i.e., either fasting glucose = 5.1 mmol/L or 1h glucose = 10.0 mmol/L or 2h glucose = 8.5 mmol/L, or a documented HbA1c of = 6.5% at first booking 2. History of pre-gestational diabetes 3. Multiple gestations in the current pregnancy 4. History of severe hyperemesis in the first trimester 5. Uncontrolled pre-gestational or gestational hypertension (BP > 150/100 mmHg) on treatment 6. History of recurrent (= 2) first-trimester spontaneous abortions or stillbirths 7. Previous child born with congenital anomalies 8. History of significant ante- or post-partum haemorrhage in the previous pregnancy 9. Pregnancy following in-vitro fertilization or any assisted reproductive technology 10. Previous or current psychiatric illness on medication, epileptic seizures or on antiepileptic medication 11. Women meeting absolute contraindications for physical activity during pregnancy as recommended by the ACOG 11.1. Heart disease 11.2. Restrictive lung disease 11.3. incompetent cervix/cerclage 11.4. Pregnancies at risk for premature labour 11.5. gestational hypertension (BP > 150/100 mmHg) 11.6. Severe anaemia _____ Previous exclusion criteria: 1. Diagnosis of pre-gestational diabetes, previous GDM based on The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria, or raised blood glucose at blooding - any of the following at first booking: 1.1. Fasting glucose =5.1 mmol/L 1.2. 1 hour glucose =10.0 mmol/L 1.3. 2 hour glucose =8.5 mmol/L 1.4. Documented HbA1c of =6.5% 2. Multiple gestation 3. History of severe hyperemesis in first trimester 4. History of hypertension (pre-gestational or gestational) 5. History or recurrent (more than two) first trimester abortions 6. History of ante- or post-partum haemorrhage in the previous pregnancy 7. Previous child born with congenital anomalies 8. Previous stillbirth or miscarriage 9. Pregnancy following in-vitro fertilisation or any assisted reproductive technology 10. Unwilling to adhere to the study protocol 11. History of or current psychiatric illness 12. History of or current neurological condition (i.e. epilepsy) 13. Meeting absolute contraindications for physical activity during preganncy as recommend by the American College of Obstetricians and Gynecologists (ACOG), including: 13.1. Heart disease 13.2. Restrictive lung disease 13.3. Incompetent cervix/cerclage 13.4. At risk for premature labour 13.5. Gestational hypertension 13.6. Severe anaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/05/2020: Incidence of gestational diabetes mellitus diagnosed based on IADPSG criteria at 26-28 weeks or fasting plasma glucose =5.1 mmol/l at week 32 (plasma glucose analysed using a Roche Cobas 800 Enzymic autoanalyser) _____ Previous primary outcome measure: Incidence of gestational diabetes mellitus according to IADPSG criteria, assessed by the following during weeks 26-28 of gestation and at 32 weeks of gestation: 1. Fasting plasma glucose, analysed using a Roche Cobas 800 Enzymic autoanalyser 2. Glucose at 1 and 2 hours post 75 g oral glucose tolerance test (OGTT), analysed using a Roche Cobas 800 Enzymic autoanalyser | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/05/2020: 1. Absolute values of fasting blood glucose concentration at 32 weeks gestational age 2. Gestational weight gain using a Digital Tanita scale (in The Gambia) and a stadiometer (in India) from randomisation to week 32 3. Blood pressure from randomisation to week 32 4. Proportion of women undergoing instrumental/caesarean delivery, assessed using the study proforma 5. Post-partum haemorrhage,assessed using the amount of blood loss after child birth from the study proforma at delivery 6. Pre-eclampsia and eclampsia, assessed using clinical diagnosis of hypertension and proteinuria (with or without seizures) from the study proforma after 28 weeks of gestation 7. Blood loss at delivery, assessed using the amount of blood loss during the delivery from the study proforma at delivery 8. Pre-term births (less than 37 weeks of gestation), determined by calculating gestational age from dating the ultrasound scan at delivery 9. Foetal macrosomia (defined as birth weight >2 standard deviations above the population-specific mean in each setting), assessed from birth weight measured using an infantometer at delivery 10. Birth weight, assessed using an infantometer at delivery 11. Physical condition of newborn infant, assessed using the clinically recorded APGAR score at 1 and 5 minutes of birth 12. Length of newborn, assessed by measuring length from the head to the heel using a non-stretchable tape within 48 hours of birth. 13. Barriers to interventions in pregnancy, assessed using a questionnaire at screening and at 32 weeks of gestation _____ Previous secondary outcome measures: 1. Gestational weight gain, assessed using a Digital Tanita scale (in The Gambia) and a stadiometer (in India) at screening, the run-in phase, the point of randomisation, visits 1, 2 and 3, and at delivery (prior to birth) 2. Requirement of insulin/metformin post-OGTT, assessed through a review of patient notes from the diagnosis of GDM to delive | — |
Countries
Gambia, India
Contacts
Public ContactSenthil Vasan
Outcome results
None listed