Actively Recruiting

Phase 2
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT07189208

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

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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