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. 2009 Jul 8;2009(3):CD003395. doi: 10.1002/14651858.CD003395.pub2

Bancroft 2000.

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