Open Access Study protocol

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

Janna M Munster123*, Alexander CAP Leenders4, Wim van der Hoek5, Peter M Schneeberger4, Ariene Rietveld6, Josien Riphagen-Dalhuisen2, Ronald P Stolk2, Carl JCM Hamilton7, Esther de Vries8, Jamie Meekelenkamp4, Jerome R Lo-Ten-Foe9, Albertus Timmer10, Lolkje TW De Jong - van den Berg1, Jan G Aarnoudse3 and Eelko Hak12

Author Affiliations

1 University of Groningen, University Centre for Pharmacy, PharmacoEpidemiology & PharmacoEconomics, Antonius Deusinglaan 1, 9713 AV, Groningen, The Netherlands

2 University Medical Centre Groningen, University of Groningen, Department of Epidemiology, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

3 University Medical Centre Groningen, University of Groningen, Department of Obstetrics and Gynaecology, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

4 Jeroen Bosch Hospital, Department of Medical Microbiology and Infection Prevention, Tolbrugstraat 11, 5211 RW, 's-Hertogenbosch, The Netherlands

5 National Institute for Public Health and the Environment, Antonie van Leeuwenhoeklaan 9, 3721 MA, Bilthoven, The Netherlands

6 Public Health Department ''Hart voor Brabant'', Vogelstraat 2, 5212 VL 's-Hertogenbosch, The Netherlands

7 Jeroen Bosch Hospital, Department of Obstetrics and Gynaecology, Tolbrugstraat 11, 5211 RW, 's-Hertogenbosch, The Netherlands

8 Jeroen Bosch Hospital, Department of Paediatrics, Tolbrugstraat 11, 5211 RW, 's-Hertogenbosch, The Netherlands

9 University Medical Centre Groningen, University of Groningen, Department of Medical Microbiology, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

10 University Medical Centre Groningen, University of Groningen, Department of Pathology and Medical Biology, Hanzeplein 1, 9700 RB, Groningen, The Netherlands

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BMC Women's Health 2010, 10:32  doi:10.1186/1472-6874-10-32

Published: 1 November 2010

Abstract

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.

Trial registration

ClinicalTrials.gov, protocol record NL30340.042.09.