HealthDay News — Initiation of isoniazid preventive therapy during pregnancy is associated with increased risks versus initiation during the postpartum period, according to a study published in the Oct. 3 issue of the New England Journal of Medicine.
Amita Gupta, M.D., from the Center for Clinical Global Health Education at Johns Hopkins University in Baltimore, and colleagues conducted a noninferiority trial involving pregnant women with HIV randomly assigned to receive isoniazid preventive therapy for 28 weeks initiated during pregnancy (immediate group; 477 women) or at week 12 after delivery (deferred group; 479 women).
The researchers found that a maternal primary outcome event occurred in 15.1 and 15.2 percent of women in the immediate and deferred groups, respectively (incidence rate, 15.03 and 14.93 events per 100 person-years, respectively; rate difference, 0.10; 95 percent confidence interval, −4.77 to 4.98, which met the noninferiority criterion). Three women in each group developed tuberculosis (incidence rate, 0.60 and 0.59 per 100 person-years, respectively; rate difference, 0.01; 95 percent confidence interval, −0.94 to 0.96). The incidence of an event included in the composite adverse pregnancy outcome (stillbirth or spontaneous abortion, low birth weight in an infant, preterm delivery, or congenital anomalies in an infant) was higher in the immediate versus the deferred group (23.6 versus 17.0 percent; difference, 6.7 percentage points; 95 percent confidence interval, 0.8 to 11.9).
“Our trial highlights the need to include pregnant women in clinical trials to inform global health policy,” the authors write.