Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

Table 3

Neonatal outcomes in treatment groups ().

Parameters	Metformin alone	Metformin + insulin	Insulin alone	value
	(%)	(%)	(%)
	Born alive
Yes	16 (100)	90 (100)	100 (100)	N/A
No	—	—	—
Small for gestational
Yes	5 (31.2)	13 (14.4)	2 (2.0)	<0.01^*
No	11 (68.8)	77 (85.6)	98 (98.0)
Large for gestational
Yes	2 (12.5)	30 (33.3)	27 (27.0)	0.208
No	14 (87.5)	60 (66.7)	73 (73.0)
Birth trauma
Yes	2 (12.5)	0 (0)	2 (2.0)	0.016^*
No	14 (87.5)	90 (100)	98 (98.0)
NICU stay
Yes	7 (43.8)	21 (23.3)	69 (69.0)	<0.01^*
No	9 (56.2)	69 (76.7)	31 (31.0)
Neonatal jaundice
Yes	2 (12.5)	9 (10.0)	25 (25.0)	0.021^*
No	14 (87.5)	81 (90.0)	75 (75.0)
TTN
Yes	2 (12.5)	6 (6.7)	18 (18.0)	0.063
No	14 (87.5)	84 (93.3)	82 (82.0)
RDS
Yes	2 (12.5)	5 (5.6)	11 (11.0)	0.355
No	14 (87.5)	85 (94.4)	89 (89.0)
Neonatal sepsis
Yes	0 (0)	3 (3.3)	10 (10.0)	0.094
No	16 (100)	87 (96.7)	90 (90.0)
Neonatal hypoglycemia
Yes	4 (25.0)	7 (7.8)	30 (30.0)	<0.01^*
No	12 (75.0)	83 (92.2)	70 (70.0)
Continuous measure outcomes
	Mean ± SD	value^a	value^b	value^c
Birth weight (kg)
Metformin alone	3.03 ± 0.65	0.305
Metformin + insulin	3.34 ± 0.68		0.345
Insulin alone	3.41 ± 0.56			0.985
Mean blood glucose level at birth (mg/dl)
Metformin alone	39.25 ± 9.32	0.062
Metformin + insulin	45.41 ± 7.94		0.335
Insulin alone	40.91 ± 14.81			0.282
Apgar score at 5 minutes
Metformin alone	8.31 ± 1.01	0.929
Metformin + insulin	8.27 ± 0.94		0.228
Insulin alone	8.05 ± 0.90			0.048^*

value calculated by using Chi-squareFisher ExactMann-Whitney test.
^aComparison between means of metformin alone and metformin + insulin groups.
^bComparison between means of metformin alone and insulin alone groups.
^cComparison between means of metformin + insulin and insulin alone groups.
^*Significant level ≤0.05.
TTN: transient tachypnea of newborn.
RDS: respiratory distress syndrome.
NICU: neonatal intensive care unit.