Table 1.
Comparison of Maternal and Infant Characteristics by Infant Randomization Arm (CTX vs. Placebo) for Infants Providing a Stool Sample
| Maternal/infant characteristics | Mothers of infants receiving CTX (n=105) | Mothers of infants receiving placebo (n=113)a | p‐value |
|---|---|---|---|
| Median maternal age (years) [IQR] | 32.5 [25.9 to 35.9] | 32.5 [28.9 to 35.9] | 0.67 |
| Gravida including current pregnancy (#, %) | |||
| One | 21 (20.0%) | 18 (15.9%) | 0.64 |
| Two | 16 (15.2%) | 20 (17.7%) | |
| Three | 31 (29.5%) | 28 (24.8%) | |
| Four or more | 37 (35.3%) | 47 (41.6%) | |
| Median enrolment CD4+ count (cells/μl) [IQR] | 526 [383 to 667] | 526 [350 to 675] | 0.85 |
| CD4+ count <200 cells/μl (#, %) | 9 (9.1%) | 9 (8.2%) | 1.0 |
| Maternal ARV regimen | |||
| Triple ARVs initiated before delivery | 60 (57.7%) | 67 (59.8%) | 0.93 |
| Triple ARVS initiated in pregnancy | 42 (40.4%) | 42 (37.5%) | |
| No ARVs | 2 (1.9%) | 3 (2.7%) | |
| Enrolment site (#, %) | |||
| Molepolole (village) | 40 (38.1%) | 45 (39.8%) | 0.89 |
| Gaborone (city) | 65 (61.9%) | 68 (60.2%) | |
| Marital status (#, %) | |||
| Single | 87 (82.9%) | 98 (86.7%) | 0.39 |
| Married/cohabitating | 18 (17.1%) | 14 (12.4%) | |
| Widowed/divorced | 0 (NA) | 1 (0.9%) | |
| Education (#, %) | |||
| None or primary | 16 (15.2%) | 11 (9.7%) | 0.40 |
| Secondary | 78 (74.3%) | 92 (81.4%) | |
| University | 11 (10.5%) | 10 (8.9%) | |
| Electricity in household (#, %) | 66 (62.9%) | 79 (69.9%) | 0.32 |
| Piped water in household (#, %) | 16 (15.2%) | 14 (12.4%) | 0.56 |
| Flush toilet in household (#, %) | 19 (18.1%) | 17 (15.0%) | 0.59 |
| Infant characteristics | CTX randomized infants (n=105) | Placebo randomized infants (n=115) | |
| Infant sex (#, %) | |||
| Male | 51 (48.6%) | 54 (47.0%) | 0.89 |
| Female | 54 (51.4%) | 61 (53.0%) | |
| Median gestational age at delivery [IQR] | 39 [37 to 40] | 39 [37 to 40] | 0.93 |
| Mean anthropometric measures | |||
| Birthweight (kg) [95% CI] | |||
| Male infants | 3.10 [2.79 to 3.30] | 2.98 [2.52 to 3.30] | 0.14 |
| Female infants | 2.89 [2.66 to 3.27] | 2.93 [2.57 to 3.20] | 0.68 |
| Birth length (cm) [95% CI] | |||
| Male infants | 51 [49 to 52] | 50 [49 to 52] | 0.30 |
| Female infants | 50 [49 to 52] | 49 [47 to 52] | 0.22 |
| Median # of days of ARV prophylaxis [IQR] | 29 [27 to 31] | 29 [27 to 30] | 0.88 |
| Breastfed (#, %) | 21 (20.0%) | 27 (23.5%) | 0.62 |
| Median age in days at 1st stool collection [IQR] | 33 [15 to 97] | 28 [14 to 96] | 0.34 |
ARVs, antiretrovirals; CI, confidence interval; IQR, interquartile range.
a
Two women gave birth to twins.