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

Schistosomiasis Clinical Trial

— Bilharzia  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03158298
• Other study ID #: ZKS0094
• Status: Terminated
• Start date: June 1, 2017
• Est. completion date: October 11, 2019

Study information

• Verified date: April 2022
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: October 11, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schistosomiasis

Intervention

Other:
• Specimen collection
Maternal blood sample of 10 ml collected by venepuncture upon delivery

Locations

Country	Name	City	State
Germany	University Hospital Jena	Jena	Thuringia

Sponsors (4)

Lead Sponsor	Collaborator
Jena University Hospital	Charite University, Berlin, Germany, Technische Universität München, University Hospital in Halle

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schistosoma Serology	Presence of Schistosoma antibodies in maternal serum	6 month after delivery
Secondary	Birth Weight	Infant birth weight	1 hour upon delivery
Secondary	Preterm Birth	Onset of delivery at a gestational age below 37 weeks	24 hours before delivery
Secondary	Intrauterine Growth Restriction	Fetal weight below the 10th percentile for the estimated gestational age	48 hours after delivery
Secondary	Stillbirth	Fetus delivered without signs of life at gestational age between 20 and 28 weeks	At delivery