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
Uncomplicated, viable pregnancy
Prior history of STIs last 3 years
HIV infection
Age < 21 years
Non-viable pregnancy
Very high risk pregnancy
Inability to provide written informed consent
Allergy to penicillin
Parallel
Benzathine penicillin 2.4 million units
DrugIM injection of BPG
Counseling and intensified testing.
BehavioralBrazilian 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.
Number of participants with absence of maternal syphilis infection
Negative POC treponemal test and VDRL test following entry into the study and at the time of labor and delivery confirming absence of maternal syphilis infection. A participant developing a positive serologic result after study entry will have reached a study endpoint and will be followed off study.
Number of participants who agree to the intervention and continue on the regimen after the first visit
For acceptability, the investigators will monitor our recruitment attempts prior to study entry to evaluate how many potential participants were offered study enrollment. For participants who enroll in the study, the investigators will evaluate how many agree to the intervention and continue on the regimen after the first visit, noting any premature study discontinuation and the reason for discontinuation using a questionnaire.
Degree of pain at the injection site from 0 to 10 according to the Numeric Ranking Scale
To assess tolerability, the investigators will offer participants an online questionnaire where they record their experience with the use of IM penicillin during the study, assessing their experience with treponemal and nontreponemal tests (both arms), the degree of pain at the injection site (0 to 10) according to the Numeric Ranking Scale in which higher scores mean worse pain, any local or systemic symptoms afterwards, duration of discomfort, or any other local or systemic findings for each study visit. The investigators will also administer a tolerability questionnaire to participants randomized to the enhanced standard of care.
Number of participants with any cardiovascular adverse event following injection of Benzathine Penicillin G
Cardiovascular adverse events are defined as any of following: hypotension, palpitations, syncope, tachycardia, and hypersensitivity reactions.
Number of participants with any pregnancy complications
Pregnancy complications are defined as emergency C-section or still birth.
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University of California, Los Angeles
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
