Table 2.
Maternal outcomes and interventions stratified by treatment group
| 17-OHP (N = 327) |
Placebo (N = 330) |
RR (95% CI) | |
|---|---|---|---|
| Delivery < 37 weeks | 82/327 (25.1) | 80/330 (24.2) | 1.03 (0.79 – 1.35) |
| Spontaneous | 54/327 (16.5) | 55/330 (16.7) | 0.99 (0.70 – 1.40) |
| Medically indicated | 27/327 (8.3) | 25/330 (7.6) | 1.09 (0.65 – 1.84) |
| Fetal loss/abortion < 20 weeks | 1/327 (0.3) | 0/330 | -- |
| Gestational age at delivery (weeks) | 37.6 ± 3.9 | 37.4 ± 4.3 | P = 0.93 |
| Preterm premature rupture of membranes | 25/327 (7.6) | 24/330 (7.3) | 1.05 (0.61 – 1.80) |
| Delivery < 35 weeks | 44/327 (13.5) | 53/330 (16.1) | 0.84 (0.58 – 1.21) |
| Delivery < 32 weeks | 28/327 (8.6) | 32/330 (9.7) | 0.88 (0.54 – 1.43) |
| Delivery < 28 weeks | 15/327 (4.6) | 22/330 (6.7) | 0.69 (0.36 – 1.30) |
| Hospital visit for preterm labor | 145/327 (44.3) | 151/330 (45.8) | 0.97 (0.82 – 1.15) |
| Tocolytic therapy | 35/321 (10.9) | 42/325 (12.9) | 0.84 (0.55 – 1.29) |
| Corticosteroid therapy | 55/321 (17.1) | 51/325 (15.7) | 1.09 (0.77 – 1.55) |
| Cerclage placement | 6/321 (1.9) | 4/325 (1.2) | 1.52 (0.43 – 5.33) |
| Gestational hypertension or preeclampsia | 46/327 (14.1) | 40/329 (12.2) | 1.16 (0.78 – 1.72) |
| Gestational diabetes mellitus | 15/327 (4.6) | 13/330 (3.9) | 1.16 (0.56 – 2.41) |
| Cholestasis | 1/327 (0.3) | 0/329 | -- |
| Placental abruption | 11/327 (3.4) | 15/328 (4.6) | 0.74 (0.34 – 1.58) |
| Chorioamnionitis | 29/327 (8.9) | 20/328 (6.1) | 1.45 (0.84 – 2.52) |
| Cesarean delivery | 67/327 (20.5) | 63/329 (19.1) | 1.07 (0.79 – 1.46) |
| Side effects | |||
| Any | 223/326 (68.4) | 220/328 (67.1) | 1.02 (0.92 – 1.13) |
| Injection site | 217/326 (66.6) | 209/328 (63.7) | 1.04 (0.93 – 1.17) |
| Urticaria | 10/326 (3.1) | 2/328 (0.6) | 5.03 (1.11 – 22.78) |
| Nausea | 7/326 (2.1) | 10/328 (3.0) | 0.70 (0.27 – 1.83) |
Data are presented as mean ± standard deviation or n/N (%)