Clinical trial NCT03158298: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schistosomiasis
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Charite University, Berlin, Germany
name: University Hospital in Halle
First posted: 2017-05-18
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis

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.

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

Primary outcomes:
measure: Schistosoma Serology
timeFrame: 6 month after delivery
Secondary outcomes:
measure: Birth Weight
timeFrame: 1 hour upon delivery
measure: Preterm Birth
timeFrame: 24 hours before delivery
measure: Intrauterine Growth Restriction
timeFrame: 48 hours after delivery
measure: Stillbirth
timeFrame: At delivery
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital Jena
state: Thuringia
Study officials:
affiliation: Center for Infectious Diseases and Infection Control, Jena University Hospital
name: Benjamin Schleenvoigt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: