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

NCT03158298 | Terminated Results

• 1 other identifier: ZKS0094
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Outcome Measures

Primary Outcomes (1)

• Schistosoma Serology

  Presence of Schistosoma antibodies in maternal serum

  6 month after delivery

Secondary Outcomes (4)

• Birth Weight

  1 hour upon delivery

• Preterm Birth

  24 hours before delivery

• Intrauterine Growth Restriction

  48 hours after delivery

• Stillbirth

  At delivery

Interventions

Specimen collection OTHER

Maternal blood sample of 10 ml collected by venepuncture upon delivery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study objectives pertain to pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jena University Hospital: lead
• Technical University of Munich: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital in Halle: collaborator

Study Sites (1)

University Hospital Jena

Jena, Thuringia, 07747, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Placenta (optional)

MeSH Terms

Conditions

Schistosomiasis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Benjamin Schleenvoigt
• Organization: Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany

benjamin.schleenvoigt@med.uni-jena.de

+49 3641 9 32 46

Study Officials

• Benjamin Schleenvoigt, M.D.

  Center for Infectious Diseases and Infection Control, Jena University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: June 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 11, 2019
• Last Updated: April 14, 2022
• Results First Posted: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)