Intervention (Glibenclamide) (n = 13) | Standard (Insulin) (n = 10) | Total (n = 23)(95% CI) | |||||
---|---|---|---|---|---|---|---|
Primary outcome: Number of women who agreed to be randomised | |||||||
Overall monthly recruitment rate (15.8 months) a | Mean {SD} | 1.45 | {1.21} | ||||
(0.92 to 2.18) | |||||||
Recruitment rate per centre per month (58.9 months) b | Mean {SD} | 0.39 | {0.62} | ||||
(0.25 to 0.59) | |||||||
Uptake rate | |||||||
Total number of women eligible | n | 25 | |||||
Proportion of those eligiblec agreeing to be randomised | n (%) | 23 | (92.0) | ||||
(74.0% to 99.0%) | |||||||
Retentiond | |||||||
Number of women who remained in the study | n (%) | 13 | (100.0) | 10 | (100.0) | 23 | (100.0) |
(85.2% to 100.0%) | |||||||
Adherence - Adhered to the treatment regimene | n (%) | 9f | (69.2) | ||||
(95% CI) | (38.6% to 90.9%) | ||||||
Safetyg | |||||||
Number of women with hypoglycaemic episodes needing treatment | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Number of women with SUSARs | n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |||
Number of women with SAEs | n (%) | 2 (15.4) | 2 (20.0) | 4 (17.4) | |||
Number of women with other adverse events | n(%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |