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due to lack of recruitment
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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| Charite University, Berlin, Germany | OTHER |
| University Hospital in Halle | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specimen collection | Other | Maternal blood sample of 10 ml collected by venepuncture upon delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Schistosoma Serology | Presence of Schistosoma antibodies in maternal serum | 6 month after delivery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Study objectives pertain to pregnant women
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Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Schleenvoigt, M.D. | Jena University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Jena | Jena | Thuringia | 07747 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Schistosoma Serology | Presence of Schistosoma antibodies in maternal serum | Posted | Count of Participants | Participants | 6 month after delivery |
|
|
adverse event data collection was not applicable to our study
adverse event data collection was not applicable to our observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | 82 mother-child pairs; women initially migrated from Bilharzia endemic countries |
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Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Schleenvoigt | Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany | +49 3641 9 32 46 | 70 | benjamin.schleenvoigt@med.uni-jena.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2015 | Jul 3, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2016 | Jul 3, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012552 | Schistosomiasis |
| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Serum Placenta (optional)
| 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 |
| Participants |
|
| Sex: Female, Male | refers on the gender of newborns (82 pregnancies with 82 mothers and 82 newborns) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Schistosomiasis Serology | Number | participants |
|
| gestational age | Median | Standard Deviation | weeks |
|
| birth weight | Median | Standard Deviation | g |
|
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| Secondary | Birth Weight | Infant birth weight | Posted | Mean | Standard Deviation | gramm | 1 hour upon delivery |
|
|
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| Secondary | Preterm Birth | Onset of delivery at a gestational age below 37 weeks | Posted | Count of Participants | Participants | 24 hours before delivery |
|
|
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| Secondary | Intrauterine Growth Restriction | Fetal weight below the 10th percentile for the estimated gestational age | all | Posted | Count of Participants | Participants | 48 hours after delivery |
|
|
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| Secondary | Stillbirth | Fetus delivered without signs of life at gestational age between 20 and 28 weeks | Posted | Count of Participants | Participants | At delivery |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D000079426 |
| Vector Borne Diseases |