Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT07189208
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07189208
Study Brief:
Protocol Section:
NCT07189208