TABLE 6.
Maternal and infant safety outcomes and TB treatment-related adverse events d
| Maternal safety events (n = 27) | n (%) | Infant safety events (n = 27) | n (%) |
|---|---|---|---|
| Mothers with one or more ≥ grade 3 adverse event | 12 (44) | Infants with one or more ≥ grade 3 adverse event | 8 (30) |
| TB treatment-related events ≥ grade 3 | TB treatment-related events ≥ grade 3 | 2 (7) | |
| Drug-induced liver injury | 5 (19) | Neutropenia at birth | 1 (4) |
| Slow metabolizer | 4 (15) | Hyperbilirubinemia in infant on INH prophylaxis | 1 (4) |
| Intermediate metabolizer | 1 (4) | ||
| Neutropenia a | 1 (4) | ||
| Other events ≥ grade 3 | Other events ≥ grade 3 | ||
| Anemia | 3 (11) | Severe birth asphyxia | 1 (4) |
| Respiratory distress of prematurity | 2 (7) | ||
| Neonatal sepsis | 1 (4) | ||
| Congenital abnormalities | 3 (11) | ||
| Jeune syndrome with intestinal malrotation | 1 (4) | ||
| Umbilical hernia c | 1 (4) | ||
| Inguinal hernia c | 1 (4) | ||
| Infant death (<3 months after birth) | 2 (7) | ||
| Acute watery diarrhea | 1 (4) | ||
| Probable sudden infant death syndrome | 1 (4) | ||
| TB treatment-related events < grade 3 | TB treatment-related events < grade 3 | ||
| Drug-induced skin rash b | 2 (7) | Elevated liver enzymes at birth | 1 (4) |
| Adverse pregnancy outcomes | Adverse birth weight outcomes | ||
| Preterm delivery (<37 weeks) | 7 (26) | Low birth weight (<2,500g) | 10 (37) |
| Moderate to late preterm (32–36+6 weeks) | 5 (19) | Very low birth weight (<1,500g) | 2 (7) |
| Severe preterm (<32 weeks) | 2 (7) | SGA | 3 (11) |
| Preeclampsia with placental ischemia | 1 (4) | IUGR | 2 (7) |
| Perineal tear hemorrhage | 1 (4) | ||
| Pregnancy-induced hypertension | 1 (4) |
a
Reported as possibly treatment-related, but more likely TB disease-related.
b
Both grade 2 and resolved before entry on TB drug discontinuation.
c
Grade 1 but grouped under congenital abnormalities.
d
SGA: small for gestational age; IUGR: intrauterine growth retardation.