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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35084
Enrollment
4000
Registered
2010-03-10
Start date
2010-04-14
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q fever

Interventions

The intervention is screening for Q fever with a single bloodsample during pregnancy. Treatment of Q fever positive patients is part of standard care of the specialist, so is not part of the interve

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects have to fulfil the following 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

Exclusion criteria: The exclusion criteria are: - unable to fulfill study procedures - absence of informed consent - have been tested positive for Q fever prior to pregnancy - unable to understand Dutch

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the 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.

Secondary

MeasureTime frame
Secondary objectives are to describe the course of infection in pregnant women, the accuracy of the diagnostic tests used for screening, the extent to which the placenta has been infected and the costs associated with health care consumption and loss of income.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)