A Screening Strategy for Q Fever Among Pregnant Women

NCT01095328 | Unknown

• 1 other identifier: NL30340.042.09
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Q Fever

Keywords

Q fever; Pregnancy; Screening; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• obstetric or maternal complications in Q fever positive women

  Presence of any obstetric or maternal complication after the first trimester of pregnancy, i.e. spontaneous abortion, intrauterine fetal death, termination of pregnancy, oligohydramnios, premature delivery or intrauterine growth retardation. Spontaneous abortion is defined as spontaneous expulsion of the embryo or the fetus before 16 weeks of gestation. Oligohydramnios is defined as the ultrasonic measurement with an amniotic index \<=5 cm. IUGR is defined as a fetal birth weight less than the 10th percentile for gestational age, according to the national reference curves.

  obstetric complications till delivery, maternal till one month post partum

Secondary Outcomes (4)

• course of infection in pregnant women

  till one month post partum

• the accuracy of the diagnostic tests used for screening

  around 20 weeks of gestation

• placentitis

  one month post partum

• costs

  till one month post partum

Study Arms (2)

intervention

EXPERIMENTAL

Screening for Q-fever during pregnancy

Other: screening

control

NO INTERVENTION

No screening for Q-fever during pregnancy

Other: screening

Interventions

screening OTHER

screening for Q-fever with a single blood sampling

control; intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to fulfill study procedures
• absence of informed consent
• have been tested positive for Q fever prior to pregnancy
• unable to understand Dutch

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

RECRUITING

Related Publications (21)

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  PMID: 18452690 BACKGROUND

• Carcopino X, Raoult D, Bretelle F, Boubli L, Stein A. Managing Q fever during pregnancy: the benefits of long-term cotrimoxazole therapy. Clin Infect Dis. 2007 Sep 1;45(5):548-55. doi: 10.1086/520661. Epub 2007 Jul 17.

  PMID: 17682987 BACKGROUND

• Parker NR, Barralet JH, Bell AM. Q fever. Lancet. 2006 Feb 25;367(9511):679-88. doi: 10.1016/S0140-6736(06)68266-4.

  PMID: 16503466 BACKGROUND

• Schimmer B, Morroy G, Dijkstra F, Schneeberger PM, Weers-Pothoff G, Timen A, Wijkmans C, van der Hoek W. Large ongoing Q fever outbreak in the south of The Netherlands, 2008. Euro Surveill. 2008 Jul 31;13(31):18939. No abstract available.

  PMID: 18761906 BACKGROUND

• Karagiannis I, Morroy G, Rietveld A, Horrevorts AM, Hamans M, Francken P, Schimmer B. Q fever outbreak in the Netherlands: a preliminary report. Euro Surveill. 2007 Aug 9;12(8):E070809.2. doi: 10.2807/esw.12.32.03247-en. No abstract available.

  PMID: 17868551 BACKGROUND

• Van Steenbergen JE, Morroy G, Groot CA, Ruikes FG, Marcelis JH, Speelman P. [An outbreak of Q fever in The Netherlands--possible link to goats]. Ned Tijdschr Geneeskd. 2007 Sep 8;151(36):1998-2003. Dutch.

  PMID: 17953175 BACKGROUND

• Jover-Diaz F, Robert-Gates J, Andreu-Gimenez L, Merino-Sanchez J. Q fever during pregnancy: an emerging cause of prematurity and abortion. Infect Dis Obstet Gynecol. 2001;9(1):47-9. doi: 10.1155/S1064744901000084.

  PMID: 11368259 BACKGROUND

• Lin JM, Brimmer DJ, Maloney EM, Nyarko E, Belue R, Reeves WC. Further validation of the Multidimensional Fatigue Inventory in a US adult population sample. Popul Health Metr. 2009 Dec 15;7:18. doi: 10.1186/1478-7954-7-18.

  PMID: 20003524 BACKGROUND

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  PMID: 10515901 BACKGROUND

• Langley JM, Marrie TJ, Leblanc JC, Almudevar A, Resch L, Raoult D. Coxiella burnetii seropositivity in parturient women is associated with adverse pregnancy outcomes. Am J Obstet Gynecol. 2003 Jul;189(1):228-32. doi: 10.1067/mob.2003.448.

  PMID: 12861167 BACKGROUND

• Raoult D, Fenollar F, Stein A. Q fever during pregnancy: diagnosis, treatment, and follow-up. Arch Intern Med. 2002 Mar 25;162(6):701-4. doi: 10.1001/archinte.162.6.701.

  PMID: 11911725 BACKGROUND

• Advice Dutch Health Council, http://www.gezondheidsraad.nl/nl/adviezen/briefadviesbijeenkomst- over-q-koorts-nederland

  BACKGROUND

• Vaidya VM, Malik SV, Kaur S, Kumar S, Barbuddhe SB. Comparison of PCR, immunofluorescence assay, and pathogen isolation for diagnosis of q fever in humans with spontaneous abortions. J Clin Microbiol. 2008 Jun;46(6):2038-44. doi: 10.1128/JCM.01874-07. Epub 2008 Apr 30.

  PMID: 18448698 BACKGROUND

• Wagner-Wiening C, Brockmann S, Kimmig P. Serological diagnosis and follow-up of asymptomatic and acute Q fever infections. Int J Med Microbiol. 2006 May;296 Suppl 40:294-6. doi: 10.1016/j.ijmm.2006.01.045. Epub 2006 Mar 9.

  PMID: 16524773 BACKGROUND

• Gikas A, Kofteridis DP, Manios A, Pediaditis J, Tselentis Y. Newer macrolides as empiric treatment for acute Q fever infection. Antimicrob Agents Chemother. 2001 Dec;45(12):3644-6. doi: 10.1128/AAC.45.12.3644-3646.2001.

  PMID: 11709360 BACKGROUND

• Stein A, Raoult D. Q fever during pregnancy: a public health problem in southern France. Clin Infect Dis. 1998 Sep;27(3):592-6. doi: 10.1086/514698.

  PMID: 9770161 BACKGROUND

• McCaughey C, McKenna J, McKenna C, Coyle PV, O'Neill HJ, Wyatt DE, Smyth B, Murray LJ. Human seroprevalence to Coxiella burnetii (Q fever) in Northern Ireland. Zoonoses Public Health. 2008 May;55(4):189-94. doi: 10.1111/j.1863-2378.2008.01109.x.

  PMID: 18387140 BACKGROUND

• Meekelenkamp JCE, Notermans DW, Rietveld A, Marcelis JH, Schimmer B, Reimerink JHJ, Vollebergh JHA, Wijkmans CJ, Leenders ACAP. Seroprevalence of Coxiella burnetii in pregnant women in the province of Noord-Brabant in 2007. Infectieziekten Bulletin, 20: 57-61 [in Dutch].

  BACKGROUND

• Dupont HT, Thirion X, Raoult D. Q fever serology: cutoff determination for microimmunofluorescence. Clin Diagn Lab Immunol. 1994 Mar;1(2):189-96. doi: 10.1128/cdli.1.2.189-196.1994.

  PMID: 7496944 BACKGROUND

• Munster JM, Leenders AC, Hamilton CJ, Meekelenkamp JC, Schneeberger PM, van der Hoek W, Rietveld A, de Vries E, Stolk RP, Aarnoudse JG, Hak E. Routine screening for Coxiella burnetii infection during pregnancy: a clustered randomised controlled trial during an outbreak, the Netherlands, 2010. Euro Surveill. 2013 Jun 13;18(24):20504.

  PMID: 23787163 DERIVED

• Munster JM, Leenders AC, van der Hoek W, Schneeberger PM, Rietveld A, Riphagen-Dalhuisen J, Stolk RP, Hamilton CJ, de Vries E, Meekelenkamp J, Lo-Ten-Foe JR, Timmer A, De Jong-van den Berg LT, Aarnoudse JG, Hak E. Cost-effectiveness of a screening strategy for Q fever among pregnant women in risk areas: a clustered randomized controlled trial. BMC Womens Health. 2010 Nov 1;10:32. doi: 10.1186/1472-6874-10-32.

  PMID: 21040534 DERIVED

MeSH Terms

Conditions

Q Fever

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Eelko Hak, Dr.

  University Medical Center Groningen

  STUDY DIRECTOR

• Janna Munster, MD, MSc

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Wim van der Hoek, Drs.

  Center for Infectious Disease Control

  PRINCIPAL INVESTIGATOR

• Ronald Stolk, Prof. dr.

  University Medical Center Groningen

  STUDY CHAIR

• Jan Aarnoudse, Prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Sander Leenders, Dr.

  Jeroen Bosch Hospital

  PRINCIPAL INVESTIGATOR

• Bert Timmer, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eelko Hak, Dr

CONTACT

+31 50 36 14616; E.Hak@epi.umcg.nl

Janna M Munster, MD, MSc

CONTACT

+31 626890978; J.Munster@og.umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 1, 2010

Record last verified: 2010-02

Locations

NL (1)