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

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

	Metformin	Placebo	p value
Primary outcome
First 24 hours	n = 47^a	n = 49^a
Hyperglycemic^b 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
Hypoglycemic^c episodes	0.1 ± 0.2	0.1 ± 0.4	0.38
	0 [0–0]	0 [0–0]	0.49
Second 24 hours	n = 46^a	n = 40^a
Hyperglycemic^b episodes	0.9 ± 1.0	1.2 ± 1.0	0.15
	1 [0–2]	1 [0–2]	0.13
Hypoglycemic^c episodes	0.7 ± 0.9	0.6 ± 0.8	0.68
	0 [0–1]	0 [0–1]	0.76
Third 24 hours	n = 37^a	n = 37^a
Hyperglycemic^b episodes	0.6 ± 1.0	0.7 ± 1.0	0.67
	0 [0–1]	0 [0–1]	0.35
Hypoglycemic^c 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 = 37^d	n = 35^d
Hyperglycemic^b episodes	5.3 ± 2.0	5.8 ± 2.2	0.32
	5 [4-7]	6 [5-7]	0.28
Hypoglycemic^c episodes	1.6 ± 1.4	1.7 ± 1.4	0.85
	2 [0–3]	1 [1-2]	0.94
Severe hypoglycemic^e episodes	0.03 ± 0.16	0.14 ± 0.43	0.14
	0 [0–0]	0 [0–0]	0.15
Day 1 to 3	n = 48^f	n = 50^f
Any hyperglycemia^b	48 (100)	50 (100)	0.51
Any hypoglycemia^c	30 (63)	34 (68)	0.56
Any severe hypoglycemia^e	1 (2)	4 (8)	0.18

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
^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
^bHyperglycemia defined as self-monitored pre meal capillary blood glucose ≥ 5.3 or 2-hour post meal ≥ 6.7 mmol/L
^cHypoglycemia defined as any self-monitored capillary blood glucose ≤ 3.9 mmol/L
^dOnly participants classified as compliant over all 3 trial days included
^eSevere hypoglycemia defined as capillary blood glucose < 3 mmol/L
^fParticipants with at least one capillary glucose reading within trial period included

ISSN: 1471-2393