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

Table 3 Other secondary trial outcomes

Outcome	Metformin	Placebo	p value
Open label antiglycemic agent^a	3/49 (6 %)	1/50 (2 %)	0.36
Nausea^b	2/49 (4 %)	0/50 (0 %)	0.24
Vomiting^b	1/48 (2 %)	0/50 (0 %)	0.49
Diarrhea^b	3/48 (6 %)	1/50 (2 %)	0.36
Mode of delivery
Spontaneous vertex delivery	19/52 (37 %)	10/51 (20 %)	0.16
Vacuum/Forceps delivery	4/52 (8 %)	5/51 (9.8 %)
Cesarean delivery	29/52 (56 %)	36/51 (71 %)
	n = 52	n = 51
Estimated blood loss (ml)	300 [213–475]	300 [300–400]	0.80
	n = 48	n = 50
VNRS SMBG^c	9 [8-10]	9 [8-10]	0.46
VNRS Allocated Medicine^d	9 [1-10]	9 [1-10]	0.23
	n = 52	n = 51
Birth weight (kg)	2.51 ± 0.61	2.66 ± 0.56	0.21
	n = 52	n = 51
Apgar Score at 1 minute	9 [9]	9 [9]	0.68
Apgar Score at 5 minutes	10 [10]	10 [10]	0.23
	n = 46	n = 50
Umbilical arterial blood pH	7.30 [7.24–7.35]	7.32 [7.25–7.35]	0.43
	n = 45	n = 47
Umbilical arterial base deficit	2.1 [0.7–4.4]	1.8 [0.8–3.7]	0.52
SCN/NICU^e Admission	18/52 (35 %)	14/51 (28 %)	0.43
Indication for NICU admission
Prematurity	6 (33.3 %)	4 (28.6 %)	0.59
Transient tachypnea of newborn	5 (27.8 %)	2 (14.3 %)
Presumed sepsis	2 (11.1 %)	4 (28.6 %)
Others^f	5 (27.8 %)	4 (28.6 %)

Data expressed as number (%), mean ± standard deviation, median [interquartile range] and number (%). Analyses by Student t test for comparisons of means, Mann Whitney U test for comparison of non-parametric or ordinal data, Chi square test for categorical datasets (Fisher’s exact test for 2 × 2 categorical datasets if any cell < 5). All tests 2-sided
^aMetformin or insulin if BSP > 11 mmol/L or at providers’ discretion for severe hyperglycemia
^bAny reported episode recorded during the 3-day trial
^cVisual numerical rating scale (scored 0–10, higher score greater satisfaction) for experience with self-monitoring of capillary blood glucose
^d Visual numerical rating scale (scored 0–10, higher score greater satisfaction) for experience with allocated medicine
^eSpecial care nursery/Neonatal intensive care unit
^f Others: neonatal jaundice 5, respiratory distress syndrome 2, duodenal atresia 1 and suspected hypoxic ischemic encephalopathy 1

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