| Methods |
Single centre randomised trial.
Randomisation method: sealed opaque envelopes.
Blinding of intervention: not stated.
Blinding of outcome assessment: not stated.
Dropouts: 5 withdrawn from the study ‐ 3 for insulin therapy, other 2 unaccounted for (possibly withdrawn following dietary advice but unclear).
Intention‐to‐treat analysis: not stated. |
| Participants |
29 women.
Inclusion criteria: impaired glucose tolerance (defined following a 75 g OGTT as 2‐hour plasma glucose level between 8 mmol/L and 11 mmol/L.
Exclusions: none stated.
Setting: joint diabetic/AN clinic. |
| Interventions |
Dietary treatment group were given specific 'diabetic type' advice (i.e. 'high fibre, high carbohydrate, low fat and appropriate energy'). The control group received no specific dietary advice. Both groups attended clinic weekly and performed plasma glucose profiles. |
| Outcomes |
Outcomes measured: caesarean section, birthweight, use of insulin. |
| Notes |
If plasma glucose levels were raised in the non‐diet group they were given dietary advice or insulin therapy, or both. An attempt to diagnose macrosomia by ultrasound was made from 30 weeks in both groups. The trial did not recruit its expected sample. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
