Evaluation of Antimicrobial Prophylaxis to Prevent Syphilis in Pregnancy in Patients at Risk in Rio de Janeiro, Brazil
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Brazil
Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)
NOT_YET_RECRUITING
Duque De Caxias
Policlínica Hospital Municipal Duque de Caxias
RECRUITING
Duque De Caxias
Unidade Básica de Saúde José de Freitas
NOT_YET_RECRUITING
Duque De Caxias
Hospital Federal dos Servidores do Estado
RECRUITING
Rio De Janeiro
Contact Information
Primary
Karin Nielsen, MD
knielsen@mednet.ucla.edu
310-825-5235
Backup
Esaú C João, MD, PhD
esaujoao@gmail.com
+55 (21) 2233-0018
Time Frame
Start Date:2025-11-01
Estimated Completion Date:2030-01-31
Participants
Target number of participants:500
Treatments
Experimental: Counseling and intensified testing and, if negative, Benzathine Penicillin G
Counseling about prevention of STIs at each pre-natal visit. Treponemal and non-treponemal tests every four weeks beginning at the 28th week of pregnancy and at delivery. If negative, IM injection of 2.4 million units of Benzathine Penicillin G. If positive, syphilis treatment based on the guidelines of the Brazilian Ministry of Health.
Active_comparator: Counseling and intensified testing without using Benzathine Penicillin G
Counseling about prevention of STIs at each pre-natal visit. Treponemal and non-treponemal tests every four weeks beginning at the 28th week of pregnancy and at delivery. If positive, syphilis treatment based on the guidelines of the Brazilian Ministry of Health.