SchistosomiasisBilharziaNCT03158298
Seropositivity and Adverse Birth Events in Migrants From Bilharzia-endemic Areas
An observational study of Schistosomiasis, run by Jena University Hospital at 1 site in Germany.
Trial summary
The study intends to examine the association between schistosomiasis seropositivity and adverse pregnancy outcomes. It aims at the verification of the hypothesis that in pregnant women originating from endemic areas for schistosomiasis, positive serology is associated with reduced Infant birth weight. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Specimen collection
- How many people
- 82 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 11 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis
Who may be able to join
- Pregnancy
- Immigration from a country/geographic area with declared endemic schistosomiasis according to World Health Organization criteria
- Signed informed consent
Who cannot join
- Placenta pathology of any cause
- Any medical condition affecting fetal growth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Schistosomiasis Seropositivity With Adverse Birth Events in Migrants From Bilharzia-endemic Areas
The study intends to examine the association between schistosomiasis seropositivity and adverse pregnancy outcomes.
It aims at the verification of the hypothesis that in pregnant women originating from endemic areas for schistosomiasis, positive serology is associated with reduced Infant birth weight.
Read the detailed description
Schistosomiasis is a widespread helminthic infection, with an estimated 249 million people in 78 countries requiring preventive treatment each year. This infection has a significant association with morbidity worldwide. Earlier studies performed in endemic Areas showed that the reproductive tract was affected in more than 60% of the women who excreted S. haematobium ova in urine. Transplacental transmission has not been observed, but schistosomiasis of the pregnant uterus has been reported and placental schistosomiasis has been associated with stillbirth. Placental schistosomiasis (i.e. detection of schistosomiasis eggs in placental tissue) has been reported occasionally. Schistosomiasis has been postulated to be associated with premature delivery and low birth weight; however, existing data are inconsistent.
Migration to the European Union was estimated at 1.7 million people in 2012. Migrants were predominantly from Africa and Asia. In these areas schistosomiasis has an estimated prevalence of 10-20%. While a large number of migrants from schistosomiasis-endemic areas enter Europe and receive Access to health care, many of them are unaware of helminthic infections they may have been exposed to, and their potential outcomes.
Treatment of schistosomiasis during pregnancy is a matter of debate. The German society for tropical medicine recommends treatment with praziquantel only after the completion of pregnancy. Conversely, the South African Medicines Formulary suggests that pregnant women should be offered treatment individually and that they should not necessarily be excluded during treatment campaigns. By quantifying the effects of Schistosoma infection on pregnancy outcomes this study will help clinicians in deciding on the question of treatment during pregnancy.
The aim of the study is to examine the association of maternal schistosomiasis on adverse birth outcomes (as defined by low birth weight, premature delivery or stillbirth) in migrants to Europe from schistosomiasis endemic areas.
- Conditions
- Schistosomiasis
- Being tested
- Specimen collection
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen collectionOther
Maternal blood sample of 10 ml collected by venepuncture upon delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Schistosoma Serology
Presence of Schistosoma antibodies in maternal serum
Measured: 6 month after delivery
Secondary outcomes (4)
Birth Weight
Infant birth weight
Measured: 1 hour upon delivery
Preterm Birth
Onset of delivery at a gestational age below 37 weeks
Measured: 24 hours before delivery
Intrauterine Growth Restriction
Fetal weight below the 10th percentile for the estimated gestational age
Measured: 48 hours after delivery
Stillbirth
Fetus delivered without signs of life at gestational age between 20 and 28 weeks
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start1 Jun 2017
- Primary completion31 Oct 2018
- Study completion11 Oct 2019
Why it stopped: due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich, Charite University, Berlin, Germany, University Hospital in Halle
- Responsible party
- Sponsor
- Investigators
- Benjamin Schleenvoigt, M.D., Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158298
- Sponsor's protocol ID
- ZKS0094
- Acronym
- Bilharzia
- Status last verified
- Apr 2022
- First submitted
- 16 May 2017
- Last updated
- 14 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Schistosomiasis Seropositivity With Adverse Birth Events in Migrants From Bilharzia-endemic Areas
- ClinicalTrials.gov ID
- NCT03158298
- Acronym / sponsor ID
- Bilharzia / ZKS0094
- Conditions
- Schistosomiasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to lack of recruitment
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Technical University of Munich, Charite University, Berlin, Germany, University Hospital in Halle
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Posted 14 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study intends to examine the association between schistosomiasis seropositivity and adverse pregnancy outcomes.
It aims at the verification of the hypothesis that in pregnant women originating from endemic areas for schistosomiasis, positive serology is associated with reduced Infant birth weight.
Detailed description
Schistosomiasis is a widespread helminthic infection, with an estimated 249 million people in 78 countries requiring preventive treatment each year. This infection has a significant association with morbidity worldwide. Earlier studies performed in endemic Areas showed that the reproductive tract was affected in more than 60% of the women who excreted S. haematobium ova in urine. Transplacental transmission has not been observed, but schistosomiasis of the pregnant uterus has been reported and placental schistosomiasis has been associated with stillbirth. Placental schistosomiasis (i.e. detection of schistosomiasis eggs in placental tissue) has been reported occasionally. Schistosomiasis has been postulated to be associated with premature delivery and low birth weight; however, existing data are inconsistent.
Migration to the European Union was estimated at 1.7 million people in 2012. Migrants were predominantly from Africa and Asia. In these areas schistosomiasis has an estimated prevalence of 10-20%. While a large number of migrants from schistosomiasis-endemic areas enter Europe and receive Access to health care, many of them are unaware of helminthic infections they may have been exposed to, and their potential outcomes.
Treatment of schistosomiasis during pregnancy is a matter of debate. The German society for tropical medicine recommends treatment with praziquantel only after the completion of pregnancy. Conversely, the South African Medicines Formulary suggests that pregnant women should be offered treatment individually and that they should not necessarily be excluded during treatment campaigns. By quantifying the effects of Schistosoma infection on pregnancy outcomes this study will help clinicians in deciding on the question of treatment during pregnancy.
The aim of the study is to examine the association of maternal schistosomiasis on adverse birth outcomes (as defined by low birth weight, premature delivery or stillbirth) in migrants to Europe from schistosomiasis endemic areas.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis
Key inclusion criteria (3 listed)
- Pregnancy
- Immigration from a country/geographic area with declared endemic schistosomiasis according to World Health Organization criteria
- Signed informed consent
Key exclusion criteria (2 listed)
- Placenta pathology of any cause
- Any medical condition affecting fetal growth
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 |
|---|---|---|
| Specimen collectionMaternal blood sample of 10 ml collected by venepuncture upon delivery | Other | – |
Primary outcome
Schistosoma Serology
Time frame: 6 month after delivery
Presence of Schistosoma antibodies in maternal serum
4 secondary outcomes
Birth Weight
Time frame: 1 hour upon delivery
Preterm Birth
Time frame: 24 hours before delivery
Intrauterine Growth Restriction
Time frame: 48 hours after delivery
Stillbirth
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Benjamin Schleenvoigt, M.D. principal investigator
Jena University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis, run by Jena University Hospital at 1 site in Germany.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Apr 2022. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schistosoma Serology (time frame: 6 month after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2022.