Skip to main content

Table 2 Primary outcome and similar secondary glycemia based outcomes after randomization to metformin or placebo

From: Prophylactic metformin after antenatal corticosteroids (PROMAC): a double blind randomized controlled trial

  Metformin Placebo p value
Primary outcome
First 24 hours n = 47a n = 49a  
Hyperglycemicb episodes 3.9 ± 1.4 4.1 ± 1.6 0.64
  4 [3-5] 4 [3-5.5] 0.49
Secondary outcomes
First 24 hours
Hypoglycemicc episodes 0.1 ± 0.2 0.1 ± 0.4 0.38
  0 [0–0] 0 [0–0] 0.49
Second 24 hours n = 46a n = 40a  
Hyperglycemicb episodes 0.9 ± 1.0 1.2 ± 1.0 0.15
  1 [0–2] 1 [0–2] 0.13
Hypoglycemicc episodes 0.7 ± 0.9 0.6 ± 0.8 0.68
  0 [0–1] 0 [0–1] 0.76
Third 24 hours n = 37a n = 37a  
Hyperglycemicb episodes 0.6 ± 1.0 0.7 ± 1.0 0.67
  0 [0–1] 0 [0–1] 0.35
Hypoglycemicc episodes 0.8 ± 0.9 1.0 ± 0.8 0.42
  1 [0-1.5] 1 [0–1] 0.38
Day 1 to 3 n = 37d n = 35d  
Hyperglycemicb episodes 5.3 ± 2.0 5.8 ± 2.2 0.32
  5 [4-7] 6 [5-7] 0.28
Hypoglycemicc episodes 1.6 ± 1.4 1.7 ± 1.4 0.85
  2 [0–3] 1 [1-2] 0.94
Severe hypoglycemice episodes 0.03 ± 0.16 0.14 ± 0.43 0.14
  0 [0–0] 0 [0–0] 0.15
Day 1 to 3 n = 48f n = 50f  
Any hyperglycemiab 48 (100) 50 (100) 0.51
Any hypoglycemiac 30 (63) 34 (68) 0.56
Any severe hypoglycemiae 1 (2) 4 (8) 0.18
  1. Data expressed as mean ± standard deviation, median [interquartile range] and number (%). Analyses by Student t test for means, Mann-Whitney u test for medians and Chi Square test for categorical data sets
  2. aNumber of monitoring compliant patients included in analysis: compliance defined as at least four of the six pre or 2-hour post meal sugar capillary blood profile points done in the relevant 24-hour block of the 3-day trial period
  3. bHyperglycemia defined as self-monitored pre meal capillary blood glucose ≥ 5.3 or 2-hour post meal ≥ 6.7 mmol/L
  4. cHypoglycemia defined as any self-monitored capillary blood glucose ≤ 3.9 mmol/L
  5. dOnly participants classified as compliant over all 3 trial days included
  6. eSevere hypoglycemia defined as capillary blood glucose < 3 mmol/L
  7. fParticipants with at least one capillary glucose reading within trial period included
\