Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
University of California, Los Angeles
500 participants
Nov 1, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria13
- 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.
Exclusion Criteria7
- 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.
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Interventions
IM injection of BPG
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)
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NCT07189208