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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

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
Sponsor: Jena University Hospital

Current Primary Outcome: Schistosoma antibodies [ Time Frame: At delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Birth weight [ Time Frame: 1 hour upon delivery ]
  Infant birth weight
• Preterm birth [ Time Frame: 24 hours before delivery ]
  Onset of delivery at a gestational age below 37 weeks
• Intrauterine growth restriction [ Time Frame: 48 hours before delivery ]
  Fetal weight below the 10th percentile for the estimated gestational age
• Stillbirth [ Time Frame: At delivery ]
  Fetus delivered without signs of life at gestational age between 20 and 28 weeks

Original Secondary Outcome: Same as current

Information By: Jena University Hospital

Dates:
Date Received: May 16, 2017
Date Started: June 1, 2017
Date Completion: August 31, 2018
Last Updated: May 16, 2017
Last Verified: May 2017