Seropositivity and Adverse Birth Events in Migrants From Bilharzia-endemic Areas (Bilharzia)

April 13, 2022 updated by: Jena University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • University Hospital Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women aged above 18, who migrated to Europe from geographic regions with endemic schistosomiasis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Schistosoma Serology
Time Frame: 6 month after delivery
Presence of Schistosoma antibodies in maternal serum
6 month after delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Birth Weight
Time Frame: 1 hour upon delivery
Infant birth weight
1 hour upon delivery
Preterm Birth
Time Frame: 24 hours before delivery
Onset of delivery at a gestational age below 37 weeks
24 hours before delivery
Intrauterine Growth Restriction
Time Frame: 48 hours after delivery
Fetal weight below the 10th percentile for the estimated gestational age
48 hours after delivery
Stillbirth
Time Frame: At delivery
Fetus delivered without signs of life at gestational age between 20 and 28 weeks
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jena University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Technical University of Munich
University Hospital in Halle

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin Schleenvoigt, M.D., Center for Infectious Diseases and Infection Control, Jena University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZKS0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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