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

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Brief Title

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

Official Title

Association of Schistosomiasis Seropositivity With Adverse Birth Events in Migrants From Bilharzia-endemic Areas

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.
    

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 Type

Observational


Primary Outcome

Schistosoma antibodies

Secondary Outcome

 Birth weight

Condition

Schistosomiasis

Intervention

Specimen collection


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

200

Start Date

June 1, 2017

Completion Date

August 31, 2018

Primary Completion Date

May 31, 2018

Eligibility 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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Benjamin Schleenvoigt, M.D., +4936419324670, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT03158298

Organization ID

ZKS0094


Responsible Party

Sponsor

Study Sponsor

Jena University Hospital

Collaborators

 St. Vincent's University Hospital, Dublin, Ireland

Study Sponsor

Benjamin Schleenvoigt, M.D., Principal Investigator, Center for Infectious Diseases and Infection Control, Jena University Hospital


Verification Date

May 2017