Table 3. Primary, Secondary, and Exploratory Outcomes According to Randomly Assigned Groups.
| Outcome | No. (%) | RR (95% CI) | P value | |
|---|---|---|---|---|
| Screen and treat (n = 3333) | Control (n = 3338) | |||
| Primary outcomes | ||||
| Birth before 37 weeks’ gestation | 127 (3.8) | 153 (4.6) | 0.83 (0.66-1.05) | .12 |
| Total costs, mean (SD), € [US $] | 3344.3 (2562.9) [3605.2] | 3272.9 (3637.8) [3528.2] | 0.96 (0.95-1.01) | .23 |
| Secondary and exploratory outcomes | ||||
| Gestational age, mean (SD) | 37.58 (2.55) | 37.52 (2.51) | 1.00 (0.99-1.01) | .37 |
| <26 wk | 6 (0.2) | 9 (0.3) | 0.66 (0.24-1.82) | .44 |
| <28 wk | 8 (0.2) | 11 (0.3) | 0.72 (0.29-1.77) | .50 |
| <32 wk | 26 (0.8) | 34 (1.0) | 0.76 (0.46-1.26) | .31 |
| In subgroups | ||||
| Nulliparous, mean (SD) | 37.67 (2.43) | 37.48 (2.58) | 1.01 (1.00-1.02) | .03 |
| Multiparous, mean (SD) | 37.49 (2.67) | 37.57 (2.42) | 0.99 (0.98-1.01) | .36 |
| Other pregnancy ending | ||||
| Spontaneous abortion (<22 weeks’ gestation) | 13 (0.4) | 10 (0.3) | 1.30 (0.58-2.91) | .59 |
| Fetal death | 20 (0.6) | 12 (0.4) | 1.65 (0.82-3.34) | .18 |
| Medical abortion/late miscarriage | 13 (0.6) | 19 (0.4) | 0.74 (0.37-1.48) | .39 |
| Pregnancy complications | ||||
| Premature rupture of membranes | 39 (1.2) | 55 (1.6) | 0.71 (0.47-1.06) | .10 |
| Intrauterine growth restriction | 72 (2.1) | 65 (2.0) | 1.11 (0.80-1.55) | .70 |
| Preeclampsia | 48 (1.4) | 47 (1.4) | 1.01 (0.68-1.50) | .88 |
| Vaginal bleeding | 84 (2.5) | 66 (2.0) | 1.27 (0.92-1.74) | .10 |
| Endometritis | 5 (0.2) | 10 (0.3) | 0.75 (0.52-1.07) | .30 |
| Length of stay for delivery, median (IQR), d | 4.0 (3.0-5.0) | 4.0 (3.0-5.0) | 0.97 (0.95-1.01) | .96 |
| Neonatal outcomes | ||||
| Birth weight, median (IQR), g | 3313.0 (3015.3-3624.8) | 3302.3 (2997.0-3636.1) | 1.01 (0.99-1.01) | .96 |
| Birth weight <2500 g | 152 (4.6) | 157 (4.7) | 0.96 (0.77-1.20) | .73 |
| Apgar score <7 at 5 min | 45 (1.4) | 30 (0.9) | 1.53 (0.96-2.42) | .08 |
| NICU care | 41 (1.2) | 50 (1.5) | 0.83 (0.55-1.25) | .37 |
| Transfer | 120 (3.6) | 139 (4.1) | 0.87 (0.68-1.10) | .36 |
| Neonate death | 4 (0.1) | 3 (0.1) | 1.31 (0.31-5.62) | .71 |
| Length of stay, median (IQR), d | 3.0 (3.0-4.0) | 3.0 (3.0-4.0) | 0.94 (0.92-1.01) | .85 |
Abbreviations: NICU, neonatal intensive care unit; RR, risk ratio.