Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016–2020

A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We analyzed pregnancy outcomes of women who became pregnant during the study. Among 740 women, 97 (13.1%) became pregnant. Of 102 pregnancies (in 97 participants), 30 (29.4%) participants were exposed to study drugs. Fetal loss was reported for 3/13 (23.1%) in the control regimen, 1/9 (11.1%) in the rifapentine/moxifloxacin regimen, and 1/8 (12.5%) in the rifapentine regimen. Among 21 live births in exposed pregnancies (7 in each arm), 1 infant with a congenital anomaly was reported in a participant on the rifapentine regimen. Among women receiving a short rifapentine/moxifloxacin regimen for tuberculosis who became pregnant, we observed no elevated rates of fetal losses or congenital anomalies.

Authors

Publication Details

Journal
Emerging infectious diseases
Published
2025-12-01
DOI
https://doi.org/10.3201/eid3112.250492
Primary Topic
Tuberculosis Research and Epidemiology
Type
article
Field-Weighted Citation Impact
0.00
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article

Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016–2020

Kelly E. Dooley, Kimberly N. Chapman Hedges, Grace Muzanyi, Wendy Carr et al.
Emerging infectious diseases
Tuberculosis Research and Epidemiology
article

Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016–2020

Kelly E. Dooley, Kimberly N. Chapman Hedges, Grace Muzanyi, Wendy Carr, Patrick P. J. Phillips, Nigel Scott, William C. Whitworth, Kia Bryant, Lakshmi Praveena Peddareddy, Nicole Brown, Neil Alexander Martinson, Ekaterina V. Kurbatova, Rosanna Boyd, Meredith G. Dixon, Susan E. Dorman, Ziyad Waja, Rodney Dawson, Susan Swindells, Payam Nahid, Jyoti S V Mathad, Richard E Chaisson
article en

Abstract

A previous study demonstrated noninferior efficacy of 4-month rifapentine/moxifloxacin regimen for tuberculosis (TB) treatment compared with the standard regimen. We analyzed pregnancy outcomes of women who became pregnant during the study. Among 740 women, 97 (13.1%) became pregnant. Of 102 pregnancies (in 97 participants), 30 (29.4%) participants were exposed to study drugs. Fetal loss was reported for 3/13 (23.1%) in the control regimen, 1/9 (11.1%) in the rifapentine/moxifloxacin regimen, and 1/8 (12.5%) in the rifapentine regimen. Among 21 live births in exposed pregnancies (7 in each arm), 1 infant with a congenital anomaly was reported in a participant on the rifapentine regimen. Among women receiving a short rifapentine/moxifloxacin regimen for tuberculosis who became pregnant, we observed no elevated rates of fetal losses or congenital anomalies.

Emerging infectious diseasesVol. 31(12)
Good health and well-being
Openalex Percentile: Top 29%
Tuberculosis Research and Epidemiology
DOIOpen Access PDFOpenAlex
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Pregnancy Outcomes after Exposure to Tuberculosis Treatment in Phase 3 Clinical Trial, 2016–2020 — Kelly E. Dooley, Kimberly N. Chapman Hedges, et al. · Emerging infectious diseases (2025) | TGRS Research Map | TGRS