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

Recruiting now · Phase 2

Conditions studied: Congenital Syphilis

In brief

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 facts

Study ID

NCT07189208

Run by

University of California, Los Angeles

People needed

500

Starts

2025-09-24

Expected to finish

2030-07-31

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Uncomplicated, viable pregnancy
• Elevated risk for syphilis acquisition (one or more of the following):
• Prior history of STIs last 3 years
• HIV infection
• Age < 21 years
• In a sexual partnership of < 3 mo., or > 3 sexual partners in the last 6 mo.
• Late initiation of prenatal care (> 14 weeks of pregnancy)
• Residence in area where syphilis prevalence is 10% or higher.
• Ability to provide written informed consent
• No allergy to penicillin
• Prenatal care at one of the sites participating in the study
• Ongoing sexual activity during study period.
• Negative rapid treponemal test at baseline.

You may not qualify if…

• Non-viable pregnancy
• Very high risk pregnancy
• Inability to provide written informed consent
• Allergy to penicillin
• Positive rapid treponemal test at baseline
• Lack of sexual activity during study period.
• Any persisting coagulation disorder that would contraindicate IM injections.

Where it is running

• Policlínica Hospital Municipal Duque de Caxias — Duque de Caxias, Rio de Janeiro, Brazil (enrolling)
• Hospital Federal dos Servidores do Estado — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
• Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM) — Duque de Caxias, Rio de Janeiro, Brazil
• Unidade Básica de Saúde José de Freitas — Duque de Caxias, Rio de Janeiro, Brazil

Full record on ClinicalTrials.gov

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