Table 1 Participant demographic and baseline characteristics
Parameters | Group A | Group B | All participants |
|---|---|---|---|
Women | |||
Number | 992 | 1,020 | 2,012 |
Age, year, median (Q1; Q3) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) | 26.0 (22.0; 30.0) |
Age, year | |||
18–25 | 491 (49.5%) | 496 (48.6%) | 987 (49.1%) |
26–34 | 408 (41.1%) | 429 (42.1%) | 837 (41.6%) |
≥35 | 93 (9.4%) | 95 (9.3%) | 188 (9.3%) |
Race—Black | 992 (100%) | 1,020 (100%) | 2,012 (100%) |
Weight, kg, median (Q1; Q3) | 59.2 (54.1; 65.0) | 59.0 (54.0; 65.2) | 59.1 (54.0; 65.0) |
Height, cm, median (Q1; Q3) | 158.0 (155.0; 162.0) | 158.0 (155.0; 163.0) | 158.0 (155.0; 163.0) |
HIV-infection status | |||
Negative | 987 (99.5%) | 1009 (98.9%) | 1996 (99.2%) |
Positive | 5 (0.5%) | 11 (1.1%) | 16 (0.8%) |
Gestational age at randomization, weeks, median (Q1; Q3) | 18.4 (14.9; 23.1) | 18.0 (14.9; 22.6) | 18.1 (14.9; 22.9) |
0–12, median (Q1; Q3) | 9.7 (9.1; 10.9) | 10.6 (9.6; 11.4) | 10.1 (9.3; 11.1) |
>12–24, median (Q1; Q3) | 17.1 (14.7; 20.4) | 16.9 (14.7; 20.0) | 17.0 (14.7; 20.1) |
>24, median (Q1; Q3) | 26.2 (25.1; 28.0) | 26.9 (25.4; 28.1) | 26.6 (25.3; 28.0) |
Trimester of enrollment | |||
First (0–12 weeks) | 53 (5.3%) | 53 (5.2%) | 106 (5.3%) |
Second (>12–24 weeks) | 733 (73.9%) | 782 (76.7%) | 1515 (75.3%) |
Third (>24 weeks) | 206 (20.8%) | 185 (18.1%) | 391 (19.4%) |
Infants | |||
Number | 964 | 981 | 1,945 |
Sex | |||
Female | 504 (52.3%) | 497 (50.7%) | 1001 (51.5%) |
Male | 460 (47.7%) | 484 (49.3%) | 944 (48.5%) |
Gestational age at birth, weeks, median (Q1; Q3) | 40.0 (39.0; 40.0) | 40.0 (39.0; 40.0) | 40.0 (39.0; 40.0) |
Gestational age at birth, weeks | |||
≥37 | 938 (97.3%) | 951 (96.9%) | 1889 (97.1%) |
≥33 to <37 | 21 (2.2%) | 28 (2.9%) | 49 (2.5%) |
≥26 to <33 | 5 (0.5%) | 1 (0.1%) | 6 (0.3%) |
<26 | 0 (0.0%) | 1 (0.1%) | 1 (0.1%) |
Head circumference, cm, median (Q1; Q3) | 35.0 (34.0; 35.0) | 35.0 (34.0; 35.0) | 35.0 (34.0; 35.0) |
Weight at birth, g, median (Q1; Q3) | 3100.0 (2800.0; 3380.0) | 3100.0 (2890.0; 3400.0) | 3100.0 (2840.0; 3400.0) |
Weight at birth, g | |||
≥2,500 | 918 (95.2%) | 931 (94.9%) | 1849 (95.1%) |
1,500–2,499 | 41 (4.3%) | 48 (4.9%) | 89 (4.6%) |
1,000–1,499 | 4 (0.4%) | 0 (0.0%) | 4 (0.2%) |
<1,000 | 0 (0.0%) | 1 (0.1%) | 1 (0.1%) |
Height at birth, cm, median (Q1; Q3) | 49.0 (48.0; 50.0) | 49.0 (48.0; 50.0) | 49.0 (48.0; 50.0) |
10-min Apgar, median (Q1; Q3) | 10.0 (10.0; 10.0) | 10.0 (10.0; 10.0) | 10.0 (10.0; 10.0) |
