Table 3.
Pre-planned Secondary and Safety Outcomes
| Randomized Group | Relative Risk (95% CI)☆ for 1-step vs 2-step | ||
|---|---|---|---|
| 1-step | 2-step | ||
| Secondary Outcomes | n (%) | n (%) | |
| Macrosomia (>4,000g)†‡ | 1178 (11.4) | 1186 (11.5) | 0.99 (0.91-1.06) |
| Small for gestational age§‡ | 937 (8.5) | 892 (8.1) | 1.05 (0.96-1.14) |
| Maternal GDM requiring insulin or oral hypoglycemic treatment¶‡ | 783 (42.6) | 431 (45.6) | 0.93 (0.87-1.03) |
| Neonatal respiratory distress‖‡ | 225 (2.0) | 227 (2.0) | 0.99 (0.82-1.18) |
| Neonatal jaundice requiring treatment‖‡ | 478 (4.3) | 476 (4.3) | 1.00 (0.88-1.13) |
| Neonatal hypoglycemia‖‡ | 1034 (9.2) | 838 (7.5) | 1.23 (1.12-1.34) |
| Components of Perinatal Composite Outcome | |||
| Stillbirth☆☆‡ | 56 (0.5) | 64 (0.6) | 0.87 (0.61-1.25) |
| Neonatal Death‖‡ | 7 (0.1) | 12 (0.1) | 0.58 (0.23-1.47) |
| Shoulder Dystocia††‡ | 239 (2.1) | 223 (2.0) | 1.07 (0.89-1.28) |
| Bone Fracture‖‡ | 59 (0.5) | 42 (0.4) | 1.40 (0.94-2.07) |
| Nerve Palsy‖‡ | 14 (0.1) | 15 (0.1) | 0.93 (0.45-1.92) |
| Safety Outcomes | |||
| Neonatal Sepsis‖‡ | 46 (0.4) | 38 (0.3) | 1.20 (0.78-1.85) |
| NICU Admits‖‡ | 526 (4.7) | 473 (4.2) | 1.11 (0.98-1.25) |
| Pre-term Birth (<37 weeks)‖‡ | 716 (6.4) | 711 (6.4) | 1.00 (0.91-1.11) |
| Pre-term Birth (<32 weeks)‖‡ | 118 (1.1) | 125 (1.1) | 0.94 (0.73-1.21) |
| Induction of Labor‡ ‡‡ | 3675 (31.3) | 3670 (31.3) | 1.00 (0.96-1.04) |
Widths of confidence intervals have not been adjusted to account for multiplicity and cannot be used to infer treatment effects
Denominator is 10,312 for 1-step and 10,275 for 2-step
Denominators vary based on ascertainment method for each outcome. The perinatal outcomes include pregnancies for which the information was available in the maternal record (stillbirth and shoulder dystocia) or in newborn records that were matched to maternal records. Reasons for unmatched newborn records include: adopted infants, deliveries within and outside the health-plan where newborn is covered by other insurance, deliveries outside the health-plan and no reimbursement for newborn care is requested, mother left the health plan prior to delivery and no information is available for newborn. Total number of unmatched newborn records were 702 for 1-step and 709 for 2-step. Of the pregnancies with a diagnosis of shoulder dystocia in the maternal record, but no matching newborn record, 30 were 1-step and 21 were 2-step. Of the pregnancies with a diagnosis of stillbirth in the maternal record, but no matching newborn record, 32 were 1-step and 31 were 2-step. For macrosomia and SGA, in addition to excluding unmatched newborn records, birthweight was not available for 192 of 1-step and 175 of 2-step. Further, macrosomia is estimated in newborns with gestational age >36 weeks. Maternal GDM requiring insulin includes only those pregnancies with GDM. Induction of labor excludes women who left the health plan prior to delivery (167 for 1-step and 156 for 2-step)
Denominator is 11,028 for 1-step and 10,986 for 2-step
Denominator is 1837 for 1-step and 945 for 2-step. Of the 1214 GDM pregnancies with A2class GDM requiring medication, 1092 (90.0%) received insulin and 64 (5.3%) received oral medication; 58 (4.8%) received both
Denominator is 11,220 for 1-step and 11,161 for 2-step
Denominator is 11,252 for 1-step and 11,192 for 2-step
Denominator is 11,250 for 1-step and 11,182 for 2-step
Denominator is 11,755 for 1-step and 11,714 for 2-step