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Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Sponsor: University of California, Los Angeles
Summary
The goal of this clinical trial is to learn if benzathine penicillin works to prevent maternal syphilis. It will also learn about the safety of benzathine penicillin. The main questions it aims to answer are: * Does benzathine penicillin lower the rate of syphilis in pregnancy? * What medical problems do participants have when taking benzathine penicillin? Researchers will compare benzathine penicillin to routine care to see if benzathine penicillin works to prevent syphilis. Participants will: * Take benzathine penicillin or receive routine care during the third trimester of pregnancy * Visit the clinic once a month for injections and tests * Report any reactions to benzathine penicillin to the study team
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-11-01
Completion Date
2030-01-31
Last Updated
2025-11-18
Healthy Volunteers
Yes
Conditions
Interventions
Benzathine penicillin 2.4 million units
IM injection of BPG
Counseling and intensified testing.
Brazilian Ministry of Health guidelines for the prevention and diagnosis of maternal syphilis consist of counseling about STI prevention and syphilis testing at the first pre-natal consultation, at a subsequent consultation during or after 28 weeks of pregnancy, at delivery, and in case of abortion or stillbirth. In this study, intensified testing refers to treponemal and non-treponemal tests once every four weeks beginning as of the 28th week of pregnancy.
Locations (4)
Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)
Duque de Caxias, Rio de Janeiro, Brazil
Policlínica Hospital Municipal Duque de Caxias
Duque de Caxias, Rio de Janeiro, Brazil
Unidade Básica de Saúde José de Freitas
Duque de Caxias, Rio de Janeiro, Brazil
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Rio de Janeiro, Brazil