NCT07189208View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

January 31, 2030

Study Completion Date

January 31, 2030

Conditions
Congenital Syphilis
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.

Trial Locations (4)

Unknown

Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM), Duque de Caxias

Policlínica Hospital Municipal Duque de Caxias, Duque de Caxias

Unidade Básica de Saúde José de Freitas, Duque de Caxias

Hospital Federal dos Servidores do Estado, Rio de Janeiro

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

University of California, Los Angeles

OTHER