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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of California, Los Angeles

About this trial

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 criteria

Qualifiers

Uncomplicated, viable pregnancy

Prior history of STIs last 3 years

HIV infection

Age < 21 years

Disqualifiers

Non-viable pregnancy

Very high risk pregnancy

Inability to provide written informed consent

Allergy to penicillin

Trial design

Treatments tested in this trial

  • Benzathine penicillin 2.4 million units
  • Counseling and intensified testing.

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator