Q FeverNCT01095328
A Screening Strategy for Q Fever Among Pregnant Women
A study testing screening in people with Q Fever, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Q Fever
- What is being tested?
- screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to fulfill study procedures
- absence of informed consent
- have been tested positive for Q fever prior to pregnancy
- unable to understand Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
Janna Munster, MD, MSc, +31 626890978, J.Munster@og.umcg.nl
Eelko Hak, Dr., +31 50 36 14616, E.Hak@epi.umcg.nl
About this study
Official title: Cost-effectiveness of a Screening Strategy for Q Fever Among Pregnant Women in Risk Areas: a Clustered Randomized Controlled Trial
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.
Read the detailed description
We will conduct a clustered randomized controlled trial among pregnant women within an area of high transmission. The study participants will be recruited by the midwives in high risk areas, defined by postal code from the RIVM. To inform the public in this area about the study we will publish an article in local newspapers. The midwife centers will be randomized to recruit pregnant women for either the control group or the intervention group. The pregnant women will receive study information by mail using the midwives patients file. It is estimated that approximately 10,000 eligible women live in the areas of transmission. After written informed consent, they will start with the strategy for which the midwife center is randomized.
Participants will be asked for a blood sample in their second trimester of pregnancy, possibly combined with the routine structural ultrasound around 20 weeks of pregnancy to minimize hospital visit. If participants are enrolled in their third trimester, they will have their blood sampling as soon as possible after inclusion.
When taking part in the intervention group the sample will be tested immediately for Q fever. If found positive for acute or chronic Q fever, patients have to be referred, according to local protocol, to a hospital for further pregnancy monitoring and long-term bacteriostatic treatment. Follow-up blood samples are required at 14 days, 3, 6 and 12 months after the first blood sampling as part of the standardized control of Q fever disease to diagnose possible chronicity of infection. Furthermore, current routine for pregnant women being treated with antibiotics against Q fever is to perform monthly blood analyses to monitor treatment, and if the serological parameters descend, these controls are brought back to once every two months. According to local protocol patients with Q fever have to deliver in hospital. After pregnancy serology should be continued with check-ups at 3, 6 and 12 months following the current protocol. Furthermore, after delivery a bacteriocide treatment with doxycycline or an alternative will be started by the specialist as part of regular health care.
In the control arm the blood samples will be stored, and analyzed for Q fever after delivery. If tested positive for Q fever after pregnancy antibiotics could be started if needed as part of regular health care.
At baseline, a questionnaire will be administered to all participants asking about the current pregnancy , pregnancy outcome of any previous pregnancies and demographics. Further risk factors for pregnancy outcome will also be obtained such as smoking and drinking behavior, risk-elevating comorbidities and medication use.
After delivery all relevant outcome data will be collected by questionnaires filled out by the midwife, GP or specialist after delivery, notably the presence of obstetric complications. One month after delivery or end of pregnancy, a last questionnaire will be administered to the participant to verify potential long-term consequences of Q fever, potential loss of income, health-related quality-of-life, fatigue and depressive symptoms. Furthermore questions will be asked about the condition of the newborn and risk-accessing questions for Q fever infection will be asked.
In the context of the secondary research questions an extra blood sample will be required, and placentas as well as amniotic fluid will be collected after delivery. The latter will only take place in a limited number of women and only if they gave birth in a hospital.
All participants will receive usual care and will be asked to visit the general practitioner if symptoms of Q fever occur. He/she will start diagnostic research and treatment or will refer the patient to the hospital. Furthermore, both arms have access to an expert team for support.
- Conditions
- Q Fever
- Being tested
- screening
- Keywords
- Q fever, Pregnancy, Screening, Cost-effectiveness
- Medical subject headings
- Q Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningOther
screening for Q-fever with a single blood sampling
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Screening for Q-fever during pregnancy Receives: Other: screening |
| control | No intervention | No screening for Q-fever during pregnancy Receives: Other: screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: obstetric complications till delivery, maternal till one month post partum
Secondary outcomes (4)
course of infection in pregnant women
maternal chronic infection or reactivation
Measured: till one month post partum
the accuracy of the diagnostic tests used for screening
the accuracy of the diagnostic tests used for screening (serology vs PCR)
Measured: around 20 weeks of gestation
placentitis
the extent to which the placenta has been infected
Measured: one month post partum
costs
The costs associated with health care consumption and other related costs among pregnant women.
Measured: till one month post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionFeb 2011 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Q FeverStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Eelko Hak, Dr., Study director, University Medical Center GroningenJanna Munster, MD, MSc, Principal investigator, University Medical Center GroningenWim van der Hoek, Drs., Principal investigator, Center for Infectious Disease ControlRonald Stolk, Prof. dr., Study chair, University Medical Center GroningenJan Aarnoudse, Prof. dr., Principal investigator, University Medical Center GroningenSander Leenders, Dr., Principal investigator, Jeroen Bosch HospitalBert Timmer, Dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095328
- Sponsor's protocol ID
- NL30340.042.09
- Status last verified
- Feb 2010
- First submitted
- 29 Mar 2010
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18452690Carcopino 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.
PubMed 17682987Parker NR, Barralet JH, Bell AM. Q fever. Lancet. 2006 Feb 25;367(9511):679-88. doi: 10.1016/S0140-6736(06)68266-4.
PubMed 16503466Schimmer 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.
PubMed 18761906Karagiannis 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.
PubMed 17868551Van 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.
PubMed 17953175Jover-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.
PubMed 11368259Lin 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.
PubMed 20003524Maurin M, Raoult D. Q fever. Clin Microbiol Rev. 1999 Oct;12(4):518-53. doi: 10.1128/CMR.12.4.518.
PubMed 10515901Langley 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.
PubMed 12861167Raoult 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.
PubMed 11911725Advice Dutch Health Council, http://www.gezondheidsraad.nl/nl/adviezen/briefadviesbijeenkomst- over-q-koorts-nederland
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.
PubMed 18448698Wagner-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.
PubMed 16524773Gikas 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.
PubMed 11709360
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of a Screening Strategy for Q Fever Among Pregnant Women in Risk Areas: a Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01095328
- Acronym / sponsor ID
- NL30340.042.09
- Conditions
- Q Fever
- Keywords
- Q fever, Pregnancy, Screening, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will conduct a clustered randomized controlled trial among pregnant women within an area of high transmission. The study participants will be recruited by the midwives in high risk areas, defined by postal code from the RIVM. To inform the public in this area about the study we will publish an article in local newspapers. The midwife centers will be randomized to recruit pregnant women for either the control group or the intervention group. The pregnant women will receive study information by mail using the midwives patients file. It is estimated that approximately 10,000 eligible women live in the areas of transmission. After written informed consent, they will start with the strategy for which the midwife center is randomized.
Participants will be asked for a blood sample in their second trimester of pregnancy, possibly combined with the routine structural ultrasound around 20 weeks of pregnancy to minimize hospital visit. If participants are enrolled in their third trimester, they will have their blood sampling as soon as possible after inclusion.
When taking part in the intervention group the sample will be tested immediately for Q fever. If found positive for acute or chronic Q fever, patients have to be referred, according to local protocol, to a hospital for further pregnancy monitoring and long-term bacteriostatic treatment. Follow-up blood samples are required at 14 days, 3, 6 and 12 months after the first blood sampling as part of the standardized control of Q fever disease to diagnose possible chronicity of infection. Furthermore, current routine for pregnant women being treated with antibiotics against Q fever is to perform monthly blood analyses to monitor treatment, and if the serological parameters descend, these controls are brought back to once every two months. According to local protocol patients with Q fever have to deliver in hospital. After pregnancy serology should be continued with check-ups at 3, 6 and 12 months following the current protocol. Furthermore, after delivery a bacteriocide treatment with doxycycline or an alternative will be started by the specialist as part of regular health care.
In the control arm the blood samples will be stored, and analyzed for Q fever after delivery. If tested positive for Q fever after pregnancy antibiotics could be started if needed as part of regular health care.
At baseline, a questionnaire will be administered to all participants asking about the current pregnancy , pregnancy outcome of any previous pregnancies and demographics. Further risk factors for pregnancy outcome will also be obtained such as smoking and drinking behavior, risk-elevating comorbidities and medication use.
After delivery all relevant outcome data will be collected by questionnaires filled out by the midwife, GP or specialist after delivery, notably the presence of obstetric complications. One month after delivery or end of pregnancy, a last questionnaire will be administered to the participant to verify potential long-term consequences of Q fever, potential loss of income, health-related quality-of-life, fatigue and depressive symptoms. Furthermore questions will be asked about the condition of the newborn and risk-accessing questions for Q fever infection will be asked.
In the context of the secondary research questions an extra blood sample will be required, and placentas as well as amniotic fluid will be collected after delivery. The latter will only take place in a limited number of women and only if they gave birth in a hospital.
All participants will receive usual care and will be asked to visit the general practitioner if symptoms of Q fever occur. He/she will start diagnostic research and treatment or will refer the patient to the hospital. Furthermore, both arms have access to an expert team for support.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: screeningScreening for Q-fever during pregnancy |
| control | No intervention | Other: screeningNo screening for Q-fever during pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- unable to fulfill study procedures
- absence of informed consent
- have been tested positive for Q fever prior to pregnancy
- unable to understand Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screeningscreening for Q-fever with a single blood sampling | Other | control, intervention |
Primary outcome
obstetric or maternal complications in Q fever positive women
Time frame: obstetric complications till delivery, maternal till one month post partum
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.
4 secondary outcomes
course of infection in pregnant women
Time frame: till one month post partum
the accuracy of the diagnostic tests used for screening
Time frame: around 20 weeks of gestation
placentitis
Time frame: one month post partum
costs
Time frame: till one month post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
- Background: PubMed 18452690Hartzell 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.
- Background: PubMed 17682987Carcopino 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.
- Background: PubMed 16503466Parker NR, Barralet JH, Bell AM. Q fever. Lancet. 2006 Feb 25;367(9511):679-88. doi: 10.1016/S0140-6736(06)68266-4.
- Background: PubMed 18761906Schimmer 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.
- Background: PubMed 17868551Karagiannis 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.
- Background: PubMed 17953175Van 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.
- Background: PubMed 11368259Jover-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.
- Background: PubMed 20003524Lin 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.
- Background: PubMed 10515901Maurin M, Raoult D. Q fever. Clin Microbiol Rev. 1999 Oct;12(4):518-53. doi: 10.1128/CMR.12.4.518.
- Background: PubMed 12861167Langley 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.
- Background: PubMed 11911725Raoult 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.
- BackgroundAdvice Dutch Health Council, http://www.gezondheidsraad.nl/nl/adviezen/briefadviesbijeenkomst- over-q-koorts-nederland
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eelko Hak, Dr. study director
University Medical Center Groningen
Janna Munster, MD, MSc principal investigator
University Medical Center Groningen
Wim van der Hoek, Drs. principal investigator
Center for Infectious Disease Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening in people with Q Fever, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eelko Hak, Dr (+31 50 36 14616, E.Hak@epi.umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstetric or maternal complications in Q fever positive women (time frame: obstetric complications till delivery, maternal till one month post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01095328, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2010.