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
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|
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|
|Estimated Enrollment :||200 participants|
|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|
- Other: Specimen collection
Maternal blood sample of 10 ml collected by venepuncture upon delivery
- Schistosoma antibodies [ Time Frame: At delivery ]Presence of Schistosoma antibodies in maternal serum
- Birth weight [ Time Frame: 1 hour upon delivery ]Infant birth weight
- Preterm birth [ Time Frame: 24 hours before delivery ]Onset of delivery at a gestational age below 37 weeks
- Intrauterine growth restriction [ Time Frame: 48 hours before delivery ]Fetal weight below the 10th percentile for the estimated gestational age
- Stillbirth [ Time Frame: At delivery ]Fetus delivered without signs of life at gestational age between 20 and 28 weeks
Biospecimen Retention: Samples Without DNA
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
|Contact: Benjamin Schleenvoigt, M.D.||+firstname.lastname@example.org|
|Contact: Mathias Pletz, M.D.||+email@example.com|
|University Hospital Jena||Recruiting|
|Jena, Thuringia, Germany, 07747|
|Contact: Benjamin Schleenvoigt, M.D. +4936419324795 firstname.lastname@example.org|
|Principal Investigator:||Benjamin Schleenvoigt, M.D.||Center for Infectious Diseases and Infection Control, Jena University Hospital|