Cost-effectiveness of a screening strategy for Q fever among pregnant women in risk areas: a clustered randomized controlled trial

J.M. Munster, A.C. Leenders, W. Van der Hoek, P.M. Schneeberger, A. Rietveld, J. Riphagen-Dalhuisen, R.P. Stolk, C.J. Hamilton, E. de Vries, J. Meekelenkamp, J.R. Lo-Ten-Foe, A. Timmer, L.T. De Jong-Van den Berg, J.G. Aarnoudse, E. Hak

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Samenvatting

Background: In The Netherlands the largest human Q fever outbreak ever reported in the literature is currently ongoing with more than 2300 notified cases in 2009. Pregnant women are particularly at risk as Q fever during pregnancy may cause maternal and obstetric complications. Since the majority of infected pregnant women are asymptomatic, a screening strategy might be of great value to reduce Q fever related complications. We designed a trial to assess the (cost-)effectiveness of a screening program for Q fever in pregnant women living in risks areas in The Netherlands.

Methods/design: We will conduct a clustered randomized controlled trial in which primary care midwife centres in Q fever risk areas are randomized to recruit pregnant women for either the control group or the intervention group. In both groups a blood sample is taken around 20 weeks postmenstrual age. In the intervention group, this sample is immediately analyzed by indirect immunofluorescence assay for detection of IgG and IgM antibodies using a sensitive cut-off level of 1: 32. In case of an active Q fever infection, antibiotic treatment is recommended and serological follow up is performed. In the control group, serum is frozen for analysis after delivery. The primary endpoint is a maternal (chronic Q fever or reactivation) or obstetric complication (low birth weight, preterm delivery or fetal death) in Q fever positive women. Secondary aims pertain to the course of infection in pregnant women, diagnostic accuracy of laboratory tests used for screening, histo-pathological abnormalities of the placenta of Q fever positive women, side effects of therapy, and costs. The analysis will be according to the intention-to-screen principle, and cost-effectiveness analysis will be performed by comparing the direct and indirect costs between the intervention and control group.

Discussion: With this study we aim to provide insight into the balance of risks of undetected and detected Q fever during pregnancy.

Originele taal-2English
Artikelnummer32
Aantal pagina's7
TijdschriftBMC Womens Health
Volume10
DOI's
StatusPublished - 2010

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