Actively Recruiting
Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Led by University of California, Los Angeles · Updated on 2025-11-18
500
Participants Needed
4
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Uncomplicated, viable pregnancy
- At least one risk factor for syphilis such as prior STIs in last 3 years, HIV infection, age under 21, new or multiple sexual partners, late start of prenatal care (after 14 weeks), or living in a high syphilis prevalence area
- Able to provide written informed consent
- No allergy to penicillin
- Receiving prenatal care at a participating site
- Sexually active during the study period
- Negative rapid treponemal test at baseline
You will not qualify if you...
- Non-viable pregnancy
- Very high risk pregnancy
- Unable to provide written informed consent
- Allergy to penicillin
- Positive rapid treponemal test at baseline
- Not sexually active during the study period
- Any ongoing coagulation disorder that prevents intramuscular injections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)
Duque de Caxias, Rio de Janeiro, Brazil
Not Yet Recruiting
2
Policlínica Hospital Municipal Duque de Caxias
Duque de Caxias, Rio de Janeiro, Brazil
Actively Recruiting
3
Unidade Básica de Saúde José de Freitas
Duque de Caxias, Rio de Janeiro, Brazil
Not Yet Recruiting
4
Hospital Federal dos Servidores do Estado
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
Research Team
K
Karin Nielsen, MD
CONTACT
E
Esaú C João, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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