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RECRUITING
NCT07189208
PHASE2

Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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

Interventions

DRUG

Benzathine penicillin 2.4 million units

IM injection of BPG

BEHAVIORAL

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