Q Fever | A Screening Strategy for Q Fever Among Pregnant Women
Q Fever research study
What is the primary objective of this study?
Q fever in the Netherlands is becoming more common. A Q fever infection is a serious threat to certain risk groups,including pregnant women. Pregnant women are more often than the general population asymptomatic. Studies from France show that an infection with Coxiella burnetii may cause obstetric complications including spontaneous abortion, intrauterine fetal death, intrauterine growth retardation and oligohydramnios. The aim of this study is to assess the effectiveness and cost effectiveness of a multidisciplinary screening program, whereby pregnant women in first line healthcare in high-risk areas for Q fever are screened with a single blood sample during pregnancy. If found positive for Q fever, advise for antibiotic treatment will follow as part of regular healthcare. Treatment is therefore not part of the study protocol. The results of this study will give more insights in the risks of asymptomatic Q fever in pregnancy and the benefits and harms of a screening strategy during pregnancy. This study will be used to give an evidence based advice to the Dutch minister of health on screening for Q fever in pregnancy.
Who is eligible to participate?
Inclusion Criteria: - being pregnant under first line healthcare - being eighteen years or older - having signed an informed consent form - having a estimated date of delivery between June 1th 2010 en December 31th 2010 Exclusion Criteria: - unable to fulfill study procedures - absence of informed consent - have been tested positive for Q fever prior to pregnancy - unable to understand Dutch
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:screeningscreening for Q-fever with a single blood sampling
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
interventionScreening for Q-fever during pregnancy
controlNo screening for Q-fever during pregnancy
Start Date: March 2010
Completed Date: March 2011
Primary Outcome: obstetric or maternal complications in Q fever positive women
Secondary Outcome: course of infection in pregnant women
Study sponsors, principal investigator, and references
Principal Investigator: Eelko Hak, Dr.
Lead Sponsor: University Medical Center Groningen
Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
Hartzell JD, Wood-Morris RN, Martinez LJ, Trotta RF. Q fever: epidemiology, diagnosis, and treatment. Mayo Clin Proc. 2008 May;83(5):574-9. doi: 10.4065/83.5.574. Review.