About this trial
Because pregnant women have been excluded from clinical research, including tuberculosis (TB) research, little is known about diagnosing, treating and preventing TB in pregnant women. We plan to perform a two-stage randomized trial that will identify best practices for screening pregnant and postpartum women for active TB (screening by symptoms vs. C-reactive protein levels) and the optimal timing of TPT initiation, relative to pregnancy (immediately during pregnancy or deferred to postpartum). Because undiagnosed TB among pregnant women with HIV is associated with many devastating complications to both the mother and fetus, this research has the potential to improve maternal and birth outcomes worldwide.
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- CRP screening (TB screening intervention arm)
- Deferred TPT (TPT delivery trial intervention arm)
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Makerere University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator