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临床试验/NCT03158298
NCT03158298终止不适用

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

Jena University Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
82
试验地点
1
主要终点
Schistosoma Serology

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancy
  • Immigration from a country/geographic area with declared endemic schistosomiasis according to World Health Organization criteria
  • Signed informed consent

排除标准

  • Placenta pathology of any cause
  • Any medical condition affecting fetal growth

结局指标

主要结局

Schistosoma Serology

时间窗: 6 month after delivery

Presence of Schistosoma antibodies in maternal serum

次要结局

  • Birth Weight(1 hour upon delivery)
  • Intrauterine Growth Restriction(48 hours after delivery)
  • Preterm Birth(24 hours before delivery)
  • Stillbirth(At delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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