Helminth infection during pregnancy alters immune responses at the fetomaternal interface

• Conditions: Haematology and clinical chemistry, Vitamin Status; B65; B83; B54; B74; Schistosomiasis [bilharziasis]; Other helminthiases; Unspecified malaria; Filariasis

• Registration Number: DRKS00016746
• Lead Sponsor: Institut für Mikrobiologie, Immunologie und Hygiene, Technische Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Presence of written consent
- Age > 18 years
- feminine
- Persons who are legally competent and mentally able to understand and follow the instructions of the study staff.
- Patient information and written declaration of consent of the test person
- Adequate bone marrow reserve with a peripheral granulocyte count >1500/µl and platelet count >40.000/µl
- No condition after recurrent thrombosis or pulmonary embolism
- no serious abnormalities during the physical examination
- Documentation of known anaphylaxias

Exclusion Criteria

- Presence of the following autoimmune diseases: Anti-phospholipid, antibody syndrome, Goodpasture syndrome, Sjögren syndrome, rheumatoid arthritis, lupus erythematosus, sarcoidosis, anti-neutrophilic cytoplasmic antibodies (ANCA syndrome), scleroderma, chronic polychondritis
- The following known immunodepressing diseases: X-chromosomal A-?-Globulinemia, severe combined immunodeficiency (SCID), common variable immunedeficiency (CVID), selective IgA deficiency
- known hepatitis B and/or C, HIV, HSV, CMV, syphilis, toxoplasmosis infection
- other, severe, active infection
- ongoing corticosteroid treatment
- transfusion-dependent anemia
- any other disease or medical treatment which, in the opinion of the investigator, would militate against participation in the study, e.g. (pre-)eclampsia, HELLP syndrome
- Persons who have a dependent/labour relationship with the sponsor or investigator.
- known cancers currently or in the past

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inclusion of the German and Gabonese cohorts and analysis of certain genes in the placenta and blood. First endpoint December 2017.

Secondary Outcome Measures

Name	Time	Method
Genetic analysis of placenta samples, immunological examination of blood samples.<br>Second endpoint: April 2019.