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

## TL;DR

This study examines pregnancy outcomes in women treated for tuberculosis and finds no increased risk of fetal loss or birth defects with a new treatment regimen.

## Contribution

The study provides new evidence on the safety of a 4-month tuberculosis treatment regimen during pregnancy.

## Key findings

- Fetal loss rates were not significantly higher in the new treatment regimen compared to the control.
- Only one congenital anomaly was reported among live births in the exposed pregnancies.

## 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.