Diabetes in pregnancy Pregnancy and Childbirth
Conditions
Interventions
Participants will be allocated 1:1 to the intervention (diet & lifestyle ± insulin) or standard care (diet & lifestyle, metformin ± insulin). Both groups will be offered insulin if fasting hyperglyca
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Singleton pregnancy between 6+0 and 30+0 weeks’ gestation inclusive 2. Aged 18 years or over and willing and able to give informed consent 3. Diagnosis of diabetes in pregnancy 3.1. Type 2 diabetes diagnosed before pregnancy and requiring pharmacological treatment OR 3.2. Type 2/GDM diagnosed <24 weeks’ gestation: abnormal glucose tolerance test, abnormal HBGM and/or HbA1C =42mmol/L OR 3.3. GDM (diagnosed 24-30 weeks): HbA1C =39mmol/L and/or abnormal glucose tolerance test 4. Abnormal HBGMb (=30 weeks) 5. Presence of at least one risk factor for placental disease 5.1. BP =130 and/or =80mmHg (clinic blood pressure) 5.2. Pulse wave velocity = 9m/s 5.3. Age =35 years 5.4. Nulliparous 5.5. Pre-eclampsia and/or small for gestational age (<10th centile) in a prior pregnancy 5.6. Mean uterine artery PI =95th centile 5.7. Placental growth factor <10th centile 6. EFW =50th centile (if =22 weeks)
Exclusion criteria
Exclusion criteria: 1. Medical contraindication to metformin 2. Known diagnosis of Type 1 diabetes 3. Multifetal pregnancy 4. Prior pregnancy complicated by shoulder dystocia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Third trimester fetal growth velocity will be assessed by change in fetal growth zscore between 20-26 weeks (average) and birth. (At each scan the estimated fetal weight (EFW) will be calculated using standard 2D biometry and fractional thigh volume (TVol) measurements using a standard formula and converted to a zscore (WHO). The delta change in zscore between the average zscore of scans performed between 20-26 weeks and the birthweight zscore will be calculated. In order to verify the primary outcome, the eCRF will capture the TVol measurement and the EFW at each scan as well as recording the 2nd trimester and 3rd trimester deviation scores. The source data (scan report) will verify the 2D biometry.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adherence/Acceptability 1.1. Number of missed doses– calculated as an average over pregnancy from the number of missed doses reported in the 7 days prior to each study visit (adjusted for number of study visits) 1.2. Undesirable effects of allocated treatment (number of women reporting undesirable effects associated with metformin and/or insulin/number of women receiving metformin or insulin treatment) 1.3. Treatment satisfaction with allocated medication regime (questionnaire) 1.4. Acceptability of allocated medication regime (questionnaire) 1.5. Secondary fetal growth outcomes: 1.6. Distribution of fetal growth zscores between treatment groups and within prespecified subgroups 1.7. Comparison of fetal growth zscores (conventional Hadlock formula EFW without TVol measurement) between treatment groups and within prespecified subgroups 1.8. Fetal growth velocity measured by growth potential realisation index (GPRI). (IGAP). https://igap.research.bcm.edu/ This online tool uses second trimester growth measurements to predict 3rd trimester growth for an individual fetus. The percentage deviation from the predicted growth is calculated and reported as GPRI. 1.9. Number of small and large for gestational age infants (defined using birthweight zscore) 2. Secondary maternal outcomes 2.1. Gestational weight gain (difference between baseline and 30-34 week visit weight adjusted for number of weeks) 2.2. Episodes of severe hypoglycaemia (blood glucose 1000mls) - pregnancy outcome case note review 2.14. Shoulder dystocia - pregnancy outcome case note review 2.15. Maternal skinfold measurements (delta change from baseline visit adjusted for gestation) 2.16. HOMA-IR (measured at 30-34 weeks) - measured in research blood samples (real time in the biochemistry lab) 3. Neonatal outcomes – clinical birth outcomes obtained from case note review 3.1. Fetal loss prior to 24 weeks’ gestation 3.2. Fetal loss from 24+0 weeks’ gestation (stillbirth) 3.3. Known early neonatal death (up t | — |
Countries
England, United Kingdom
Contacts
Public ContactJenny Myers
Outcome results
None listed