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Seropositivity and Adverse Birth Events in Migrants From Bilharzia-endemic Areas (Bilharzia)

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ClinicalTrials.gov Identifier: NCT03158298
Recruitment Status : Unknown
Verified May 2017 by Jena University Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
St. Vincent's University Hospital, Dublin, Ireland
Information provided by (Responsible Party):
Jena University Hospital

Brief 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.


Condition or disease Intervention/treatment
Schistosomiasis Other: Specimen collection

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association of Schistosomiasis Seropositivity With Adverse Birth Events in Migrants From Bilharzia-endemic Areas
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Specimen collection
    Maternal blood sample of 10 ml collected by venepuncture upon delivery


Primary Outcome Measures :
  1. Schistosoma antibodies [ Time Frame: At delivery ]
    Presence of Schistosoma antibodies in maternal serum


Secondary Outcome Measures :
  1. Birth weight [ Time Frame: 1 hour upon delivery ]
    Infant birth weight

  2. Preterm birth [ Time Frame: 24 hours before delivery ]
    Onset of delivery at a gestational age below 37 weeks

  3. Intrauterine growth restriction [ Time Frame: 48 hours before delivery ]
    Fetal weight below the 10th percentile for the estimated gestational age

  4. Stillbirth [ Time Frame: At delivery ]
    Fetus delivered without signs of life at gestational age between 20 and 28 weeks


Biospecimen Retention:   Samples Without DNA
Serum Placenta (optional)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study objectives pertain to pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis
Criteria

Inclusion Criteria:

  • Pregnancy
  • Immigration from a country/geographic area with declared endemic schistosomiasis according to World Health Organization criteria
  • Signed informed consent

Exclusion Criteria:

  • Placenta pathology of any cause
  • Any medical condition affecting fetal growth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158298


Contacts
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Contact: Benjamin Schleenvoigt, M.D. +4936419324670 benjamin.schleenvoigt@med.uni-jena.de
Contact: Mathias Pletz, M.D. +4936419324794 mathias.pletz@med.uni-jena.de

Locations
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Germany
University Hospital Jena Recruiting
Jena, Thuringia, Germany, 07747
Contact: Benjamin Schleenvoigt, M.D.    +4936419324795    benjamin.schleenvoigt@med.uni-jena.de   
Sponsors and Collaborators
Jena University Hospital
St. Vincent's University Hospital, Dublin, Ireland
Investigators
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Principal Investigator: Benjamin Schleenvoigt, M.D. Center for Infectious Diseases and Infection Control, Jena University Hospital
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Responsible Party: Jena University Hospital
ClinicalTrials.gov Identifier: NCT03158298    
Other Study ID Numbers: ZKS0094
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases