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A Screening Strategy for Q Fever Among Pregnant Women

NCT01095328 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2010-07-01

No results posted yet for this study

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

Interventions

OTHER

screening

screening for Q-fever with a single blood sampling

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Eelko Hak, Dr. · University Medical Center Groningen

  • Janna Munster, MD, MSc · University Medical Center Groningen

  • Wim van der Hoek, Drs. · Center for Infectious Disease Control

  • Ronald Stolk, Prof. dr. · University Medical Center Groningen

  • Jan Aarnoudse, Prof. dr. · University Medical Center Groningen

  • Sander Leenders, Dr. · Jeroen Bosch Hospital

  • Bert Timmer, Dr. · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095328 on ClinicalTrials.gov