Trial Outcomes & Findings for Seropositivity and Adverse Birth Events in Migrants From Bilharzia-endemic Areas (NCT NCT03158298)

NCT ID: NCT03158298

Last Updated: 2022-04-14

Results Overview

Presence of Schistosoma antibodies in maternal serum

• Recruitment status: TERMINATED
• Target enrollment: 82 participants
• Primary outcome timeframe: 6 month after delivery
• Results posted on: 2022-04-14

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	82
Overall Study COMPLETED	82
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	42 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	40 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	82 participants n=5 Participants
Schistosomiasis Serology	82 participants n=5 Participants
gestational age	39.71 weeks STANDARD_DEVIATION 2.43 • n=5 Participants
birth weight	3318 g STANDARD_DEVIATION 623 • n=5 Participants

PRIMARY outcome

Timeframe: 6 month after delivery

Presence of Schistosoma antibodies in maternal serum

Outcome measures

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Schistosoma Serology	0 Participants

SECONDARY outcome

Timeframe: 1 hour upon delivery

Infant birth weight

Outcome measures

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Birth Weight	3273 gramm Standard Deviation 573

SECONDARY outcome

Timeframe: 24 hours before delivery

Onset of delivery at a gestational age below 37 weeks

Outcome measures

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Preterm Birth	5 Participants

SECONDARY outcome

Timeframe: 48 hours after delivery

Population: all

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

Outcome measures

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Intrauterine Growth Restriction	7 Participants

SECONDARY outcome

Timeframe: At delivery

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

Outcome measures

Measure	Study Group n=82 Participants Pregnant women \>18 years originally from endemic countries and areas for Bilharzia (as defined by WHO) who give written informed consent to the study.
Stillbirth	0 Participants

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Benjamin Schleenvoigt

Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Germany

Phone: +49 3641 9 32 46

Email: benjamin.schleenvoigt@med.uni-jena.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place