An observational study in Schistosomiasis, sponsored by Jena University Hospital. Terminated at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by Jena University Hospital · Observational
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.
79 studies on the registry are indexed under Schistosomiasis; 14 are open to participants now.
This study's enrollment of 82 is below the median of 532 across 25 observational studies indexed under Schistosomiasis.
Browse Schistosomiasis studies →Jena University Hospital is the lead sponsor of 64 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maternal blood sample of 10 ml collected by venepuncture upon delivery
Schistosoma Serology
Presence of Schistosoma antibodies in maternal serum
Time frame: 6 month after delivery
Birth Weight
Infant birth weight
Time frame: 1 hour upon delivery
Preterm Birth
Onset of delivery at a gestational age below 37 weeks
Time frame: 24 hours before delivery
Intrauterine Growth Restriction
Fetal weight below the 10th percentile for the estimated gestational age
Time frame: 48 hours after delivery
Stillbirth
Fetus delivered without signs of life at gestational age between 20 and 28 weeks
Time frame: At delivery
| Milestone | Study Group |
|---|---|
| Started | 82 |
| Completed | 82 |
| Not completed | 0 |
Presence of Schistosoma antibodies in maternal serum
| Participants | Study Group |
|---|---|
| Schistosoma Serology | 0 |
Infant birth weight
| gramm | Study Group |
|---|---|
| Birth Weight | 3273 ± 573 |
Onset of delivery at a gestational age below 37 weeks
| Participants | Study Group |
|---|---|
| Preterm Birth | 5 |
Fetal weight below the 10th percentile for the estimated gestational age
| Participants | Study Group |
|---|---|
| Intrauterine Growth Restriction | 7 |
Fetus delivered without signs of life at gestational age between 20 and 28 weeks
| Participants | Study Group |
|---|---|
| Stillbirth | 0 |
Collected over adverse event data collection was not applicable to our study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group | — | — | — |
| Age, Categorical(Participants) | Study Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 82 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Study Group |
|---|---|
| Female | 30 |
| Male | 52 |
| Race (NIH/OMB)(Participants) | Study Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 42 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 40 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Study Group |
|---|---|
| Germany | 82 |
| Schistosomiasis Serology(participants) | Study Group |
|---|---|
| Number | 82 |
| gestational age(weeks) | Study Group |
|---|---|
| Median | 39.71 ± 2.43 |
| birth weight(g) | Study Group |
|---|---|
| Median | 3318 ± 623 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in Oct 2018, 16 months.
Results were first posted in Apr 2022, 3 years 5 months after primary completion.
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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Jena University Hospital