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

Terminated

Conditions: Schistosomiasis

Registration Number: NCT03158298

Lead Sponsor: Jena University Hospital

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 82

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Schistosoma Serology	6 month after delivery	Presence of Schistosoma antibodies in maternal serum

Secondary Outcome Measures

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