Table 5.
Maternal Treatment, Pregnancy, and Infant Outcomes Stratified by Bedaquiline Exposure
| Maternal RR-TB Treatment Outcomes | Bedaquiline in Regimen n = 58 No. (%) | No Bedaquiline in Regimen n = 50 No. (%) | P Value |
|---|---|---|---|
| Maternal MDR/RR-TB treatment outcomes | .349 | ||
| Favorable treatment outcomes | 41 (71%) | 31 (62%) | |
| Cured | 34 (59%) | 24 (48%) | |
| Treatment completion | 7 (12%) | 7 (14%) | |
| Unfavorable treatment outcomes | 17 (29%) | 19 (38%) | |
| Died | 4 (7%) | 4 (8%) | |
| Treatment failed | 2 (4%) | 1 (2%) | |
| Loss to follow-up | 11 (19%) | 14 (28%) | |
| Pregnancy outcomes | Bedaquiline exposure in utero n = 49 | No bedaquiline exposure in utero n = 60 | |
| Newborn characteristics | |||
| Birth outcomes | .741 | ||
| Live births | 45 (92%) | 54 (90%) | |
| Gestational age at delivery: weeks, mean; SDa | 37·68; SD 2·93 | 37·82; SD 3·25 | .830 |
| Birth weight, grams, median [IQR]b | 2690 [2380–3095] | 2900 [2550–3270] | .179 |
| Fetal and neonatal deaths | 4 (8%) | 6 (10%) | |
| Stillbirth | 3 (5%) | 3 (6%) | |
| Miscarriage | 0 | 3 (6%)c | |
| Termination of pregnancy | 1 (2%) | 0 | |
| Pregnancy outcomes | .312 | ||
| Favorable pregnancy outcomes (out of 109 fetuses) | 24 (49%) | 34 (57%) | |
| ≥37 weeksa | 32 (71%) | 39 (72%) | |
| Birth weight ≥2500 gb | 24 (55%) | 37 (74%) | |
| Unfavourable pregnancy outcomes (out of 109 fetuses) | 25 (51%) | 26 (43%) | |
| Fetal and neonatal deaths | 4 (8%) | 6 (10%) | |
| Preterm <37 weeksa | 13 (29%) | 15 (28%) | .903 |
| Low birth weight <2500 gb | 20 (45%) | 13 (26%) | .034 |
| Infant outcomes | Bedaquiline exposure in utero n = 49 | No bedaquiline exposure in utero n = 60 | |
| No infant outcomes at 12 months | 8 (16%) | 15 (25%) | |
| Fetal and neonatal deaths | 4 (8%) | 6 (10%) | |
| Lost to follow-up after birth | 4 (8%) | 9 (15%) | |
| Infant outcomes | n = 41 | n = 45 | .136 |
| Favorable infant outcomes at 12 months | 36 (88%) | 36 (80%) | |
| Thriving normally | 36 (88%) | 37 (82%) | .914 |
| Normal development | 38 (93%) | 39 (86%) | .705 |
| Unfavorable infant outcomes at 12 months | 5 (12%) | 9 (20%) | |
| Failure to thrive | 4 (10%) | 5 (11%) | |
| Delayed development | 2 (5%) | 3 (7%) | |
| Early neonatal death | 0 | 1 (2%) | |
| Infant death | 1 (2%) | 0 | |
| Developed TB in the 1st year of life | 0 | 2 (4%) | .186 |
Abbreviations: IQR, interquartile range; MDR/RR-TB, multidrug/rifampicin-resistant TB; SD, standard deviation; TB, tuberculosis.
aLive births only (n = 99).
bLive births only and missing data for 5 neonates (n = 94).
cOne miscarriage was a set of twins.