Cost-effectiveness of a real-time screening strategy for bacterial vaginosis using qPCR to prevent preterm birth: results from a randomized prospective multicenter study.

OBJECTIVE

Conventional diagnosis tests for vaginal flora abnormalities in pregnant women are heterogeneous and not easily reproducible, and treatments have been shown insufficient if not combined with screening for recurrence. This paper investigates, alongside a randomised controlled trial, the cost-effectiveness of testing pregnant women for bacterial vaginosis with a point-of-care polymerase chain reaction screening combined with treatment and screening for recurrence (S&T) vs. standard of care.

METHODS

Clinical and costs data of 6,671 pregnant women were collected from the AuTop trial. Administrative databases were used to fulfill resource utilization data. The perspective of the French health insurance was adopted, using national tariffs schedules when existed, such as for qPCR. The time horizon was less than one year, corresponding to the follow-up of the trial. The reduction in preterm birth rate was used as primary outcome and subgroup analyses were performed based on risk level.

RESULTS

Compared to standard of care, S&T reduced the rate of preterm births (3.8% vs. 4.6%) while the mean costs were higher, leading to a ratio of €13,730 per preterm birth averted. For multiparous women at low-risk of preterm birth, S&T was less effective and more costly than standard care. For nulliparous women, S&T appeared to be both more effective and less costly (-€4,663 per preterm birth averted). Probabilistic sensitivity analyses confirmed this dominance.

CONCLUSIONS

Our findings suggest that S&T with a point-of-care molecular test for bacterial vaginosis offers benefits in terms of preterm birth avoided among nulliparous pregnant women and is also expected to result in cost savings in this subgroup compared to standard care.

TRIAL REGISTRY: ClinicalTrials.gov, NCT02288832. 7th October 2014.