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

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

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.

Study Overview

• Status: Terminated
• Conditions: Schistosomiasis
• Intervention / Treatment: Other: Specimen collection

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07747
      • University Hospital Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schistosoma Serology	Presence of Schistosoma antibodies in maternal serum	6 month after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth Weight	Infant birth weight	1 hour upon delivery
Preterm Birth	Onset of delivery at a gestational age below 37 weeks	24 hours before delivery
Intrauterine Growth Restriction	Fetal weight below the 10th percentile for the estimated gestational age	48 hours after delivery
Stillbirth	Fetus delivered without signs of life at gestational age between 20 and 28 weeks	At delivery

Collaborators and Investigators

• Sponsor: Jena University Hospital
• Collaborators: Charite University, Berlin, Germany; Technical University of Munich; University Hospital in Halle
• Investigators: Principal Investigator: Benjamin Schleenvoigt, M.D., Center for Infectious Diseases and Infection Control, Jena University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Helminthiasis; Trematode Infections; Schistosomiasis
• Other Study ID Numbers: ZKS0094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No