Fast and reliable easy-to-use-diagnostics for eliminating Bilharzia in young children and mothers (freeBILy)

Phase 3

• Conditions: Schistosomiasis

• Registration Number: PACTR201905784271304
• Lead Sponsor: Bernhard Nocht Institute of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5200

Inclusion Criteria

Informed consent signed (from the parents for minors)
- Expected residency in the area of the study site for the next 24 months
- Pregnant women between their 5th and 6th months of pregnancy
- Children born from an enrolled mother, including twins
- Willingness to comply with the protocol requirements including: sampling and treatment for
both mothers and children

Exclusion Criteria

- Fever (temporary exclusion)
- History of transfusion
- History of congenital anaemia
- Epileptic or convulsive episodes
- Non-pregnant women
- Pregnant women younger than 16 years old
- Pregnant women who have not completed their 4th month of pregnancy
- Pregnant women over their 6th month of pregnancy
- Pregnant women who do not live in the area of the CSB
- Children born from mothers not enrolled in the study
- Children born in a CSB different from the ones in which the mothers were enrolled

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Height for age at 24 months will be used to measure the impact of TBST. Weight and height of<br>children will be measured at birth, at 9 months and 24 months of age.;Maternal Hb at 24 months after delivery will be used to measure the impact of TBST. Maternal Hb will be measured at enrolment before delivery (8th month of pregnancy), 9 months after delivery and at two years after delivery.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the POC-CCA test compared to the panel reference standard (measured in the cross-sectional study at Imerentsiatosika and Andina).;Prevalence of S. mansoni and S. haematobium in pregnant women and U5 children;Women’s quality of life related to health (measured by EQ-5D tool) and capacity to work and<br>earn in routine activities;Costs of the interventions