Monthly penicillin to prevent syphilis during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, unblinded Phase 2 trial comparing monthly intramuscular benzathine penicillin G (2.4 million units) plus enhanced counseling and testing to enhanced standard of care (counseling and monthly treponemal and non-treponemal tests) beginning at 28 weeks of pregnancy. Participants who are negative for syphilis at baseline and meet prespecified risk criteria will receive monthly clinic visits for testing and injections through delivery. The primary maternal endpoint is absence of treponemal and non-treponemal evidence of syphilis at delivery, and the primary infant endpoint is absence of congenital syphilis. Safety monitoring will record adverse reactions to penicillin and any pregnancy-related complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Uncomplicated, viable pregnancy
2. Elevated risk for syphilis acquisition (one or more of the following):

   1. Prior history of STIs last 3 years
   2. HIV infection
   3. Age \< 21 years
   4. In a sexual partnership of \< 3 mo., or \> 3 sexual partners in the last 6 mo.
   5. Late initiation of prenatal care (\> 14 weeks of pregnancy)
   6. Residence in area where syphilis prevalence is 10% or higher.
3. Ability to provide written informed consent
4. No allergy to penicillin
5. Prenatal care at one of the sites participating in the study
6. Ongoing sexual activity during study period.
7. Negative rapid treponemal test at baseline.

Exclusion Criteria:

1. Non-viable pregnancy
2. Very high risk pregnancy
3. Inability to provide written informed consent
4. Allergy to penicillin
5. Positive rapid treponemal test at baseline
6. Lack of sexual activity during study period.
7. Any persisting coagulation disorder that would contraindicate IM injections.

Where it's running

• Policlínica Hospital Municipal Duque de Caxias
  Duque de Caxias, Rio de Janeiro, Brazil Recruiting
• Hospital Federal dos Servidores do Estado
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM)
  Duque de Caxias, Rio de Janeiro, Brazil Not yet recruiting
• Unidade Básica de Saúde José de Freitas
  Duque de Caxias, Rio de Janeiro, Brazil Not yet recruiting

Study contacts

• Study coordinator: Karin Nielsen, MD
• Email: knielsen@mednet.ucla.edu
• Phone: 310-825-5235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.