Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in R… (NCT07189208) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Brazil500 participantsStarted 2025-11-01
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Non-viable pregnancy
✕. Very high risk pregnancy
✕. Inability to provide written informed consent
✕
What they're measuring
1
Number of participants with absence of maternal syphilis infection