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Table 1 Comparison of demographic and medical characteristics of the two study groups in the ITT population

From: Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial

  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