Schistosomiasis
Conditions
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 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.
Interventions
OTHERSpecimen collection
Maternal blood sample of 10 ml collected by venepuncture upon delivery
Sponsors
Technical University of Munich
Charite University, Berlin, Germany
University Hospital in Halle
Jena University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnancy * Immigration from a country/geographic area with declared endemic schistosomiasis according to World Health Organization criteria * Signed informed consent
Exclusion criteria
* Placenta pathology of any cause * Any medical condition affecting fetal growth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schistosoma Serology | 6 month after delivery | Presence of Schistosoma antibodies in maternal serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth Weight | 1 hour upon delivery | Infant birth weight |
| Preterm Birth | 24 hours before delivery | Onset of delivery at a gestational age below 37 weeks |
| Intrauterine Growth Restriction | 48 hours after delivery | Fetal weight below the 10th percentile for the estimated gestational age |
| Stillbirth | At delivery | Fetus delivered without signs of life at gestational age between 20 and 28 weeks |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants |
| birth weight | 3318 g STANDARD_DEVIATION 623 |
| gestational age | 39.71 weeks STANDARD_DEVIATION 2.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 42 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Germany | 82 participants |
| Schistosomiasis Serology | 82 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Schistosoma Serology
Presence of Schistosoma antibodies in maternal serum
Time frame: 6 month after delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Schistosoma Serology | 0 Participants |
Secondary
Birth Weight
Infant birth weight
Time frame: 1 hour upon delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Birth Weight | 3273 gramm | Standard Deviation 573 |
Secondary
Intrauterine Growth Restriction
Fetal weight below the 10th percentile for the estimated gestational age
Time frame: 48 hours after delivery
Population: all
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Intrauterine Growth Restriction | 7 Participants |
Secondary
Preterm Birth
Onset of delivery at a gestational age below 37 weeks
Time frame: 24 hours before delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Preterm Birth | 5 Participants |
Secondary
Stillbirth
Fetus delivered without signs of life at gestational age between 20 and 28 weeks
Time frame: At delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Group | Stillbirth | 0 Participants |