Gillen 2004.
Methods | Single centre randomised controlled trial. Randomisation method: open table of random numbers constructed by an independent person and kept confidential from members of the study team. Women were matched consecutively to the next available number in the table and the study team informed of the result. Blinding of intervention: yes, participants unaware of differences in advice between intervention and control groups. Blinding of outcome assessment: not stated. Intention‐to‐treat analysis was used. Dropouts: data not available for 1 woman from each group. | |
Participants | 32 women.
Inclusion criteria: GDM (defined on an OGTT defined by the Australian Diabetes in Pregnancy Society).
Exclusions: significant other health concerns, poor English language skills.
Setting: diabetic clinic. Intention‐to‐treat analysis was used. |
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Interventions | Control group: standard clinical practice (individualised carbohydrate portion‐controlled meal plan, with low‐fat and low‐glycaemic index dietary strategies and general advice about meeting nutritional requirements of pregnancy). Intervention group: standard clinical practice as above, plus advice for targeted intakes of foods rich in unsaturated fats. | |
Outcomes | Outcomes: gestation at delivery, mode of delivery. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |