Background: ART-initiation before or early pregnancy has been associated with adverse pregnancy outcomes; however such findings could be confounded by ART eligibility, ART regimen and methodological issues. We assessed the risk of adverse pregnancy outcomes by ART initiation pre- or post- conception using data from a randomized trial in Abidjan to provide evidence on pre-conception ART safety.
Methods: We investigated adverse pregnancy outcomes (stillbirth, small for gestational age [SGA], preterm delivery [PTD] and low birthweight [LBW]) in first pregnancies; a composite outcome was calculated as any adverse pregnancy outcome. In the TEMPRANO trial women were assigned to either early (irrespective of CD4 count) or deferred (WHO standard) TDF-based ART. Risks of adverse outcomes were analyzed by trial randomisation strategy (intent-to-treat) to account for timing of ART initiation in relation to conception; further, in a per-protocol analysis, women in the deferred ART strategy who became ART eligible and initiated ART before conception (e.g. before the end of the first pregnancy trimester) were excluded. Pregnancy was determined at each follow-up visit and confirmed by urine test. Gestational age was based on ultrasound. Adjusted Odds Ratios (aOR) were estimated in logistic regression allowing for women''s age, parity, and the nearest CD4 cell count before conception.
Results: In total, 119 and 122 pregnancies were reported, with 83 and 86 deliveries leading to 80 and 83 live births, in the early and deferred ART strategy respectively; 17 women in the deferred ART strategy started ART before conception, their exclusion resulted in 66 live births in this group. Overall, about 3.5% of pregnancies resulted in stillbirths; among livebirths 21% were LBW, 19% PTD and 23% SGA. Risk of adverse pregnancy outcomes did not differ significantly by randomisation strategy in either intent-to-treat or per-protocol analysis (Table 1). Risk of any of adverse pregnancy outcome (composite variable) was not associated with trial arm (intent-to-treat) or timing of ART initiation (before or after conception).
Conclusions: Using data from women randomly allocated to initiate ART immediately or deferred, our results provide reassuring evidence on the lack of association with timing of ART pre- or post-conception. Adverse pregnancy outcomes were common in this population however.



[Risk of adverse pregnancy outcomes by study randomization strategy or by timing of ART initiation before or after conception]

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