Table 1.
Comparison of demographic and medical characteristics of the two study groups in the ITT population
| Diclegis (n-131) | Placebo (n = 125) | P -value | |
|---|---|---|---|
| Ethnicity: | 0.48 | ||
| Hispanic or Latino | 53 (40.5%) | 56 (44.8%) | |
| Not Hispanic or Latino | 78 (59.5%) | 69 (55.2%) | |
| Race: | 0.59 | ||
| Asian | 2 (1.5%) | 1 (0.8%) | |
| Black or African American | 49 (37.4%) | 48 (38.4%) | |
| White or Caucasian | 80 (61.1%) | 73 (58.4%) | |
| Unknown | 3 (2.4%) | ||
| Previous Pregnancy | 101 (77.1%) | 94 (75.2%) | 0.64 |
| Smoking during pregnancy | 17 (13.0%) | 16 (12.8%) | 0.97 |
| Maternal Age (yr) | 25.9 ± 6 | 25.0 ± 5.7 | 0.23 |
| Weight (kg) | 74.10 ± 22.30 | 75.91 ± 22.19 | 0.50 |
| (lbs) | 163.35 ± 49.17 | 167.34 ± 48.91 | 0.50 |
| BMI (kg/m2): | 0.42 | ||
| Underweight | 5 (3.8%) | 4 (3.2%) | |
| Normal | 39 (29.8%) | 38 (30.4%) | |
| Overweight | 31 (23.7%) | 40 (32.0%) | |
| Obese | 55 (42.0%) | 42 (33.6%) | |
| BMI (kg/m2) | 0.95 | ||
| Mean ± SD | 28.77 ± 7.60 | 29.67 ± 11.20 | |
| Median | 27.97 | 26.83 | |
| Gestational age at start of NVP (weeks) | 0.90 | ||
| Mean ± SD | 5.5 ± 1.8 | 5.4 ± 1.7 | |
| Gestational age at enrollment (weeks) | 0.75 | ||
| Mean ± SD | 9.3 ± 2.0 | 9.3 ± 1.8 | |
| PUQE score at Enrollment | 0.44 | ||
| Mean ± SD | 9.0 ± 2.1 | 8.8 ± 2.1 | |
| Median | 9.0 | 8.0 | |
| Global Assessment of Well Being | |||
| Mean ± SD | 5.0 ± 2.3 | 5.4 ± 2.2 | |
| Median | 5.0 | 5.0 |