| Methods |
Randomised controlled pilot study recruiting from 2 centres.
Randomisation method: computer‐generated codes, telephone randomisation service used.
Blinding of intervention: "the diabetologist was aware of the group to which each woman was randomised but the obstetrician was blinded".
Blinding of outcome assessment: not stated.
No drop‐outs but 12 failed to attend follow‐up postnatal measurements.
Intention‐to‐treat analysis: not stated (but all women remained in their allocated groups). |
| Participants |
68 women.
Inclusion criteria: impaired glucose tolerance (defined following 75 gm OGTT as fasting < 7.0 mmol/L, 2‐hours between 7.8 mmol/L and 11.0 mmol/L).
Exclusions: none stated.
Setting: specialist diabetic/AN clinics. |
| Interventions |
Monitored group were given standard dietary advice, glucose metabolism was monitored by capillary glucose series 5 days a week, HbA1c was measured monthly (insulin was introduced if 5 or more capillary measurements > 7.0 mmol/L in 1 week), serial ultrasound for growth and amniotic fluid, Doppler studies, CTG monitoring.
Unmonitored group received dietary advice, HbA1c monthly but no capillary glucose measurements. |
| Outcomes |
Primary outcome measure was admission to special care baby unit.
Secondary outcomes: perinatal morbidity (including birth trauma, metabolic disturbance, gestation at delivery, birthweight), measures of maternal inconvenience, number of antenatal clinic visits, mode of delivery, frequency of insulin use. |
| Notes |
2 women in the unmonitored group developed diabetes mellitus, both were diagnosed postnatally and both delivered prematurely. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
