Table I.
Baseline characteristics of the participants (intention to treat analysis)a.
| rhG-CSF | Placebo | |
|---|---|---|
| Characteristics | (N = 76) | (N = 74) |
| Maternal age – yrb | ||
| Median | 32 | 31 |
| Interquartile range | 29–34 | 26–33 |
| Maternal BMI | 26.3 ± 4.2 | 25.8 ± 4.2 |
| Maternal BMI >30 – no. (%) | 17(22.4) | 13(17.6) |
| Maternal race – no. (%)c | ||
| White | 71(93.4) | 63(85.1) |
| Black | 0 | 2(2.7%) |
| Asian | 4(5.3) | 5(6.8) |
| Other, including mixed race | 1(1.3) | 1(5.4) |
| Maternal smoking – no (%) | ||
| Nonsmoker | 62(81.6) | 61(82.4) |
| <10 cigarettes/day | 10(13.2) | 7(9.5) |
| 10 to 19 cigarettes/day | 3(3.9) | 6(8.1) |
| ≥20 cigarettes/day | 1(1.3) | 0 |
| Alcohol use – no. (%)d | ||
| None | 36(47.4) | 35(47.3) |
| ≤3 units/day | 27(35.5) | 26(35.1) |
| >3 to ≥20 units/day | 13(17.1) | 13(17.6) |
| >20 units/day | 0 | 0 |
| Parity | ||
| Previous live birth – no. (%) | 38(50.0) | 37(50.0) |
| ≥4 previous miscarriages – no. (%) | 40(52.6) | 40(54.1) |
| Previous pregnancy losses – no. | ||
| Median | 4.0 | 4.0 |
| Interquartile range | 3–5 | 3–5 |
| Clinical risk factors – no. (%) | ||
| Polycystic ovaries | 2(2.6) | 6(8.1) |
| Fibroids | 5(6.6) | 3(4.1) |
| Large-loop excision of the cervical transformation zone | 2(2.6) | 8(10.8) |
| Concurrent medications – no. (%) | ||
| Metformin | 1(1.3) | 2(2.7) |
| Aspirin | 13(17.1) | 10(13.5) |
aPlus – minus values are means ± SD. The baseline data (age, body mass index [BMI; the weight in kilograms divided by the square of the height in meters], maternal race, smoking status and parity) of the participants were similar in the two study groups.
bListed is the maternal age at the time of randomization.
cRace was self-reported.
dOne unit is 10 g of pure alcohol.