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Volume 31, Number 12—December 2025

CME ACTIVITY - Research

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

Ekaterina V. KurbatovaComments to Author , William C. Whitworth, Kia E. Bryant, Meredith G. Dixon, Kelly E. Dooley, Nigel A. Scott, Rosanna Boyd, Nicole E. Brown, Kimberley N. Chapman Hedges, Wendy Carr, Lakshmi P. Peddareddy, Grace Muzanyi, Rodney Dawson, Ziyad Waja, Neil Martinson, Jyoti S.V. Mathad, Payam Nahid, Susan Swindells, Richard E. Chaisson, Susan E. Dorman, Patrick P.J. Phillips, and AIDS Clinical Trials Group A5349,1 and Tuberculosis Trials Consortium Study 312
Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (E.V. Kurbatova, W.C. Whitworth, K.E. Bryant, M.G. Dixon, N.A. Scott, R. Boyd, N.E. Brown, K.N. Chapman Hedges, W. Carr, L.P Peddareddy); Vanderbilt University Medical Center, Nashville, Tennessee, USA (K.E. Dooley); Uganda–Case Western Reserve University Research Collaboration, Kampala, Uganda (G. Muzanyi); University of Cape Town Lung Institute, Cape Town, South Africa (R. Dawson); University of the Witwatersrand Perinatal HIV Research Unit, Johannesburg, South Africa (Z. Waja, N. Martinson); Weill Cornell Medical College, New York, New York, USA (J.S.V. Mathad); University of California Center for Tuberculosis, San Francisco, California, USA (P. Nahid, P.P.J. Phillips); University of Nebraska Medical Center, Omaha, Nebraska, USA (S. Swindells); Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (R.E. Chaisson); Medical University of South Carolina, Charleston, South Carolina, USA (S.E. Dorman)

Main Article

Table 3

Infants with congenital anomalies born to participants who became pregnant during the TB treatment-shortening trial, Tuberculosis Trials Consortium Study 31/AIDS Clinical Trials Group A5349, January 2016–July 2020*

Case Description of congenital anomaly Study regimen Mother’s age at enrollment, y Total no. study doses mother received Total no. study doses fetus exposed EDC calculation method Infant’s gestational age, wks
1
 Musculoskeletal disorder, including clubfeet and myopathy
 RPT
 26
 118
 41
 LMP + 14 d and ultrasound in second trimester
 39
2 Umbilical hernia and right inguinal hernia RPT/MOX 22 121 0 LMP + 14 d 30

*EDC, estimated date of conception; LMP, last menstrual period; MOX, moxifloxacin; RPT, rifapentine; TB, tuberculosis.

Main Article

1Members of this group are listed at the end of this article.

2Members of this group are listed at the end of this article.

Page created: September 16, 2025
Page updated: December 29, 2025
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