Table 2. Primary Composite Neonatal Outcome and Components.
| Metformin plus insulin (n = 397)a | Insulin plus placebo (n = 397)a | Unadjusted absolute difference (95% CI) | Adjusted odds ratio (95% CI)b | |
|---|---|---|---|---|
| Composite primary outcomec | 280 (71) | 292 (74) | −3.95 (−11.49 to 3.99) | 0.86 (0.63 to 1.19) |
| Live birthsd | 386 (97) | 384 (97) | ||
| Fetal and neonatal death | 11 (3) | 13 (3) | −4.30 (−24.54 to 15.95) | 0.83 (0.36 to 1.89) |
| Miscarriage <20 wk | 7 (2) | 4 (1) | ||
| Stillbirth ≥20 wk | 3 (1) | 7 (2) | ||
| Neonatal death <28 d | 1 (<1) | 2 (1) | ||
| Preterm birth <37 wk | 130 (34) | 143 (37) | −3.89 (−11.27 to 3.49) | 0.86 (0.64 to 1.16) |
| Neonatal hypoglycemia | 152 (39) | 162 (42) | −2.91 (−10.09 to 4.28) | 0.89 (0.67 to 1.19) |
| Birth trauma | 16 (4) | 16 (4) | −0.14 (−17.83 to 17.56) | 1.02 (0.50 to 2.07) |
| Umbilical artery pH <7.05 | 9 (2) | 9 (2) | ||
| Shoulder dystocia | 7 (2) | 7 (2) | ||
| Hyperbilirubinemia requiring phototherapy | 87 (23) | 92 (24) | −1.99 (−10.35 to 6.37) | 0.93 (0.66 to 1.30) |
| Large for gestational age (>90th percentile) | 100 (26) | 137 (36) | −11.46 (−19.04 to −3.88) | 0.63 (0.46 to 0.86) |
| Small for gestational age (<10th percentile) | 30 (8) | 26 (7) | 3.71 (−9.86 to 17.28) | 1.17 (0.68 to 2.02) |
| Low birth weight (<2500 g) | 81 (21) | 73 (19) | 3.08 (−5.73 to 11.90) | 1.14 (0.80 to 1.63) |
Eleven participants in the metformin plus insulin group and 15 in the insulin plus placebo group had missing data, and as prespecified in the statistical analysis plan, are assumed to have the composite primary outcome.
Adjusted by study site, timing of diabetes diagnosis (pregestational vs diagnosed early in pregnancy), gestational age at randomizations stratified at 18 weeks, and baseline maternal body mass index as a continuous variable.
Preterm birth before 37 weeks’ gestation, neonatal hypoglycemia, birth trauma, hyperbilirubinemia, large for gestational age, small for gestational age, and low birth weight odds ratios are reported for live births (observed and assumed) and are adjusted for all baseline characteristics noted in Table 1, except study site as some sites had too few events.
Percent values for the following categories: preterm birth, neonatal hypoglycemia, birth trauma, umbilical artery pH, shoulder dystocia, hyperbilirubinemia requiring phototherapy, large for gestational age, small for gestational age, and low birth weight are calculated from live birth denominators.