Table 1.
Baseline characteristics of the study population stratified by treatment group
| 17-OHP (N = 327) |
Placebo (N = 330) |
|
|---|---|---|
| Maternal age at screening (years) | 22.8 ± 5.3 | 21.6 ± 4.4 |
| Pre-pregnancy body mass index (kg/m2)† | 26.1 ± 6.9 | 25.4 ± 6.5 |
| Race/ethnicity‡ | ||
| Non-Hispanic White | 76 (23.2) | 74 (22.4) |
| Non-Hispanic Black | 179 (54.7) | 161 (48.8) |
| Hispanic White | 19 (5.8) | 38 (11.5) |
| Hispanic Black | 2 (0.6) | 0 |
| Asian | 4 (1.2) | 3 (0.9) |
| Other | 47 (14.4) | 54 (16.4) |
| Prior pregnancy | ||
| < 13 weeks of gestation | 92 (28.1) | 82 (24.8) |
| 13–19 weeks of gestation | 13 (4.0) | 10 (3.0) |
| Payment for obstetric care | ||
| Uninsured/self-pay | 17 (5.2) | 30 (9.1) |
| Private insurance | 74 (22.6) | 62 (18.8) |
| Government-assisted insurance | 236 (72.2) | 238 (72.1) |
| Married or living with partner | 125 (38.2) | 110 (33.3) |
| Alcohol use during pregnancy | 33 (10.1) | 20 (6.1) |
| Smoking during pregnancy | 48 (14.7) | 62 (18.8) |
| Illicit substance use during pregnancy | 15 (4.6) | 24 (7.3) |
| Gestational age at randomization (weeks) | 21.4 ± 1.2 | 21.3 ± 1.3 |
| Cervical length at screening (mm) | 23.9 ± 5.6 | 23.8 ± 5.7 |
| Cervical length at screening < 15 mm | 25 (7.6) | 31 (9.4) |
| Cervical funnel present□ | 88 (26.9) | 69 (20.9) |
| Cervical funnel length (mm)□ | 14.8 ± 8.0 | 16.7 ± 8.7 |
| Debris present | 39 (11.9) | 39 (11.8) |
Data are presented as mean ± standard deviation or n (%).
The only between-group difference that was significant was maternal age at screening (P = 0.003).
Percentages may not total 100 percent due to rounding.
†
Values were unavailable for 4 mothers in the 17-OHP group and 9 mothers in the placebo group.
‡
Race or ethnicity was self-reported.
□
Values were available for all mothers with a funnel present; 88 in the 17-OHP group and 69 in the placebo group.