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

• Sponsor: Jena University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03158298
• Collaborator: Technische Universität München (Other), Charite University, Berlin, Germany (Other), University Hospital in Halle (Other)
• Enrollment: 82
• Location: 1
• Actual Duration (Months): 28.3
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schistosomiasis	Other: Specimen collection

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 Design

• Study Type: Observational
• Actual Enrollment: 82 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Association of Schistosomiasis Seropositivity With Adverse Birth Events in Migrants From Bilharzia-endemic Areas
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Oct 11, 2019

Outcome Measures

Primary Outcome Measures

1. Schistosoma Serology [6 month after delivery]

   Presence of Schistosoma antibodies in maternal serum

Secondary Outcome Measures

1. Birth Weight [1 hour upon delivery]

   Infant birth weight

2. Preterm Birth [24 hours before delivery]

   Onset of delivery at a gestational age below 37 weeks

3. Intrauterine Growth Restriction [48 hours after delivery]

   Fetal weight below the 10th percentile for the estimated gestational age

4. Stillbirth [At delivery]

   Fetus delivered without signs of life at gestational age between 20 and 28 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Jena	Jena	Thuringia	Germany	07747

Sponsors and Collaborators

• Jena University Hospital
• Technische Universität München
• Charite University, Berlin, Germany
• University Hospital in Halle

Investigators

• Principal Investigator: Benjamin Schleenvoigt, M.D., Center for Infectious Diseases and Infection Control, Jena University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 2, 2015
• Informed Consent Form - Jan 5, 2016

More Information

Publications

None provided.

• Responsible Party: Jena University Hospital
• ClinicalTrials.gov Identifier: NCT03158298
• Other Study ID Numbers: ZKS0094
• First Posted: May 18, 2017
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schistosomiasis

Study Results

Participant Flow

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Period Title: Overall Study
STARTED	82
COMPLETED	82
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Overall Participants	82
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	82 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	30 36.6%
Male	52 63.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	42 51.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	40 48.8%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Germany	82 100%
Schistosomiasis Serology (participants) [Number]
Number [participants]	82 100%
gestational age (weeks) [Median (Standard Deviation) ]
Median (Standard Deviation) [weeks]	39.71 (2.43)
birth weight (g) [Median (Standard Deviation) ]
Median (Standard Deviation) [g]	3318 (623)

Outcome Measures

1. Primary Outcome

Title	Schistosoma Serology
Description	Presence of Schistosoma antibodies in maternal serum
Time Frame	6 month after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Measure Participants	82
Count of Participants [Participants]	0 0%

2. Secondary Outcome

Title	Birth Weight
Description	Infant birth weight
Time Frame	1 hour upon delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Measure Participants	82
Mean (Standard Deviation) [gramm]	3273 (573)

3. Secondary Outcome

Title	Preterm Birth
Description	Onset of delivery at a gestational age below 37 weeks
Time Frame	24 hours before delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Measure Participants	82
Count of Participants [Participants]	5 6.1%

4. Secondary Outcome

Title	Intrauterine Growth Restriction
Description	Fetal weight below the 10th percentile for the estimated gestational age
Time Frame	48 hours after delivery

Outcome Measure Data

Analysis Population Description

all

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Measure Participants	82
Count of Participants [Participants]	7 8.5%

5. Secondary Outcome

Title	Stillbirth
Description	Fetus delivered without signs of life at gestational age between 20 and 28 weeks
Time Frame	At delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Group
Arm/Group Description	Pregnant women >18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Measure Participants	82
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	adverse event data collection was not applicable to our study
Adverse Event Reporting Description	adverse event data collection was not applicable to our observational study
Arm/Group Title	Study Group
Arm/Group Description	82 mother-child pairs; women initially migrated from Bilharzia endemic countries
All Cause Mortality
	Study Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Study Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Study Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.