Adverse pregnancy outcomes more common when isoniazid initiated during pregnancy
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The risk for adverse pregnancy outcomes is higher among women with HIV who initiate isoniazid preventive therapy for tuberculosis during pregnancy compared with those who initiate it after delivery, study data confirmed.
Past research demonstrated a greater risk for treatment-related adverse events among mothers who initiated isoniazid treatment during pregnancy, suggesting that the best time to start isoniazid is after delivery.
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In the IMPAACT P1078 study, a randomized noninferiority study, Gerard Theron, MD, head of the department of obstetrics and gynecology at Stellenbosch University, and colleagues compared the safety of starting isoniazid preventive therapy (IPT) in during pregnancy with starting IPT after delivery. The study showed that IPT during pregnancy increased the risk for composite adverse pregnancy outcomes but not individual outcomes.
“More hepatoxicity occurred in both arms of study than our a priori expectation,” Theron told Healio, adding that an added surprise finding was an increase in a composite adverse pregnancy outcome in the immediate arm (IPT during pregnancy) of the study. “This lent support for the suggestion to defer IPT to after delivery.”
“There were many covariates that could have influenced the surprise finding of an increase in a composite adverse pregnancy outcome,” Theron said. “A substudy using univariable and multivariable logistic regression adjusting for factors associated with pregnancy outcomes was necessary.”
Theron and colleagues randomly assigned woman to initiate 28 weeks of IPT either during pregnancy or at 12 weeks following delivery. According to the study, they used univariable and multivariable logistic regression to adjust for factors associated with pregnancy outcomes to analyze composite and individual adverse pregnancy outcome measures.
Overall, 925 mother-infant pairs were included. According to the study, adjusted odds of fetal demise, preterm delivery, low birth weight or congenital anomaly were 1.63 times higher among women on immediate compared with deferred IPT (95% CI, 1.15, 2.31). The study demonstrated that the odds of fetal demise, preterm delivery, low birth weight or neonatal death within 28 days were 1.62 times higher among women on immediate IPT (95% CI, 1.14, 2.30). The odds of early neonatal death within 7 days, fetal demise, preterm delivery or low birth weight were 1.74 times higher among women on immediate IPT (95% CI, 1.22, 2.49).
“Our findings provide support for deferring the initiation of IPT in healthy pregnant women living with HIV on [ART] to 12 weeks postpartum,” Theron said.
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