Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03158298
Study type Observational
Source Jena University Hospital
Contact
Status Terminated
Phase
Start date June 1, 2017
Completion date October 11, 2019

See also
  Status Clinical Trial Phase
Completed NCT04115072 - Treatment of Female Genital Schistosomiasis (FGS) With Praziquantel: A Proof-of-Concept Study Phase 2/Phase 3
Not yet recruiting NCT05999825 - Sm-p80 Schistosomiasis Challenge Study Phase 2
Completed NCT00463931 - Using Community-Based Volunteers to Reach Non-Enrolled School Aged Children Through Community-Directed Treatment of Schistosomiasis in School-Aged Children in Rural Northern Ghana N/A
Completed NCT00276224 - Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia N/A
Completed NCT00215267 - The Effect of Praziquantel Treatment on Schistosoma Mansoni Morbidity and re-Infection Along Lake Victoria, Uganda N/A
Completed NCT03845140 - L-PZQ ODT in Schistosoma Infected Children Phase 3
Completed NCT01512277 - Clinical Trial of Bilhvax,a Vaccine Candidate Against Schistosomiasis Phase 1
Active, not recruiting NCT03910972 - Sm-TSP-2 Schistosomiasis Vaccine in Healthy Ugandan Adults Phase 1/Phase 2
Completed NCT05085470 - Repeated Controlled Human Schistosoma Mansoni Infection N/A
Completed NCT02755324 - Single-sex Controlled Human Schistosomiasis Infection: Safety and Dose Finding N/A
Recruiting NCT05868005 - Delivering a Multi-disease Screening Tool to Migrant Populations N/A
Active, not recruiting NCT01869465 - Evaluation of Strategies for Improved Uptake of Preventive Treatment for Intestinal Schistosomiasis N/A
Completed NCT01553552 - Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal N/A
Recruiting NCT04589390 - Selexipag for the Treatment of Schistosomiasis-Associated Pulmonary Arterial Hypertension Phase 2
Completed NCT02868385 - Repeated Doses of Praziquantel in Schistosomiasis Treatment (RePST) Phase 3
Recruiting NCT05762393 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar Phase 1
Not yet recruiting NCT06182176 - Effectiveness and Cost-effectiveness of Integrated Model for Malaria and Helminth Control N/A
Active, not recruiting NCT05292391 - Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults Phase 1
Completed NCT03110757 - A Phase Ib Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel)(R) With or Without AP 10-701 for Intestinal Schistosomiasis in Healthy Exposed Adults Phase 1
Completed NCT01154049 - Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis Phase 1