qPCR Screening for Bacterial Vaginosis and Preterm Birth

Key Takeaways

• The qPCR-based screening, treatment, and recurrence-screening pathway was associated with a lower overall preterm birth rate than standard care.
• Overall costs were higher with the screening pathway, even as fewer preterm births were observed.
• Findings were less favorable in low-risk multiparous women, while nulliparous women showed a more favorable clinical and economic pattern.

In the AuTop trial, point-of-care qPCR screening for bacterial vaginosis, paired with treatment and recurrence screening, was associated with fewer preterm births than standard care. Overall preterm birth occurred in 3.8% of the screening group and 4.6% of the standard-care group. The randomized prospective multicenter comparison used preterm birth reduction as its primary outcome and also assessed costs during the same follow-up period. Clinical and economic outcomes were therefore evaluated in the same study population. Even with that overall pattern, the findings were not uniform across patient subgroups.

The study enrolled 6,671 pregnant women in a randomized prospective multicenter design. It compared point-of-care qPCR screening for bacterial vaginosis, combined with treatment and recurrence screening, with standard care. Administrative databases supplied resource-utilization data, and the analysis adopted the French health insurance perspective. Investigators noted that conventional vaginal flora tests were heterogeneous and not easily reproducible, while treatment without recurrence screening had been considered insufficient. The time horizon was less than one year, matching trial follow-up for both the clinical and economic analyses.

Across the full trial population, the screening pathway lowered preterm birth frequency but raised mean costs compared with standard care. From the French health insurance perspective, that tradeoff corresponded to €13,730 per preterm birth averted. The estimate reflected payer spending within the trial-based economic framework and did not extend beyond the study follow-up period. Administrative resource-use inputs kept the costing analysis aligned with observed care during the less-than-one-year time horizon. Overall, the strategy was associated with fewer preterm births and higher mean cost.

Subgroup analyses showed that parity and baseline risk shaped the findings. Among multiparous women at low risk of preterm birth, the screening-and-treatment strategy was less effective and more costly than standard care. In nulliparous women, the same approach was more effective and less costly, with an estimate of -€4,663 per preterm birth averted. Probabilistic sensitivity analyses supported that dominant pattern in nulliparous women within the modeled comparison.