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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI187414 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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:
Participants will:
Syphilis rates during pregnancy have been rising consistently in Brazil in the last decade, with a parallel increase in the rates of congenital syphilis. The state of Rio de Janeiro, in particular, has consistently had the highest rate of gestational syphilis in the country. It is critical to develop an intervention to reduce the risk of syphilis infection during pregnancy, especially for women most at risk of acquiring congenital syphilis. The investigators hypothesize that routine counseling on prevention of sexually transmitted infections (STIs) and the use of benzathine penicillin G (BPG) prophylaxis during pregnancy may help reduce the rates of syphilis in high risk pregnant populations and congenital syphilis. The investigators propose a randomized, unblinded clinical trial using BPG prophylaxis in pregnant women at higher risk of syphilis during pregnancy. The primary objective is to prevent the development of gestational syphilis and congenital syphilis through counseling on prevention of STIs, monthly treponemal and non-treponemal tests beginning in the 28th week of pregnancy and for those testing negative monthly IM injections of BPG, compared to counseling on prevention of STIs and monthly treponemal and non-treponemal tests beginning in the 28th week of pregnancy (enhanced standard of care). The primary maternal endpoint is a negative POC treponemal test and VDRL test at delivery confirming absence of maternal syphilis infection. The primary infant endpoint is absence of congenital syphilis.
The study population is pregnant persons testing negative for syphilis at 28 weeks' of pregnancy but who are at higher risk of contracting syphilis during pregnancy. The study plans to enroll at the Hospital Federal dos Servidores do Estado or at maternity hospitals. Study participants with a viable pregnancy and no significant pregnancy complications until the time of enrollment who meet the inclusion and exclusion criteria are randomized to receive counseling about prevention of STIs, enhanced serological screening, and if testing negative receive 2.4 million units of BPG IM at 28 weeks of pregnancy (+/- one week), 32 weeks (+/- one week) and 36 weeks (+/- one week) or counseling and enhanced serological screening (enhanced standard of care). The duration of the study will be 3.5 years for recruitment of participants, 6 months to complete follow-up and one additional year for data analysis, data write up and publishing of results. The duration of participation for each pregnant person will be 4 to 5 months (from 28 weeks of gestational age to delivery). Infants will be followed in the neonatal period (first 4 weeks of life).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling and intensified testing and, if negative, Benzathine Penicillin G | Experimental | 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. |
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| Counseling and intensified testing without using Benzathine Penicillin G | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzathine penicillin 2.4 million units | Drug | IM injection of BPG |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Labor and delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Uncomplicated, viable pregnancy
Elevated risk for syphilis acquisition (one or more of the following):
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Nielsen, MD | Contact | 310-825-5235 | knielsen@mednet.ucla.edu | |
| Esaú C João, MD, PhD | Contact | +55 (21) 2233-0018 | esaujoao@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Referencia e Atenção Especializada a Saúde da Mulher (CRAESM) | Not yet recruiting | Duque de Caxias | Rio de Janeiro | Brazil |
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| Counseling and intensified testing. | Behavioral | Brazilian 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. |
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| First study visit through 28 days after delivery |
| 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. | First study visit through 28 days after delivery |
| 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. | First study visit to labor and delivery |
| Number of participants with any pregnancy complications | Pregnancy complications are defined as emergency C-section or still birth. | Delivery through 4 weeks after delivery |
| Number of participants with any dermatologic adverse event following injection of Benzathine Penicillin G | A dermatologic adverse event will be defined as any of the following: acute, generalized rash, diaphoresis, dermatitis, infection of skin or other subcutaneous tissues, pruritus, skin discoloration, ulceration at injection site, any type of allergic reaction, or urticaria. | First study visit to labor and delivery |
| Number of participants with fever following injection of Benzathine Penicillin G | Fever will be defined as axillary temperature of 37.2°C or higher or rectal, oral, tympanic, or temporal artery temperature of 38°C higher. | First study visit to labor and delivery |
| Number of participants with any gastrointestinal adverse events following injection with Benzathine Penicillin G | A gastrointestinal adverse event will be defined as any of the following: hematochezia, nausea, diarrhea, or vomiting | First study visit to labor and delivery |
| Number of participants with genitourinary adverse events following injection with Benzathine Penicillin G | A genitourinary adverse event is defined as hematuria or proteinuria. | First study visit to labor and delivery |
| Number of participants with hepatic adverse events following injection with Benzathine Penicillin G | A hepatic adverse event is defined as increased transaminases (AST/ALT). | First study visit to labor and delivery |
| Number of participants with immunologic adverse events following injection with Benzathine Penicillin G | An immunologic adverse event is defined as eosinophilia or other systemic allergic reactions | First study visit to labor and delivery |
| Number of participants with local injection site reactions following injection of Benzathine penicillin G | Local injection site reactions are defined as discomort or aching at the injection site, pain upon touch of the injection site, erythema, swelling, induration, pruritus, or bruising. | First study visit to labor and delivery |
| Number of participants with neurologic adverse events following injection of Benzathine Penicillin G | Neurologic adverse events are defined as anxiety, confusion, fatigue, headache, or pain | First study visit to labor and delivery |
| Gestational age at delivery of live born neonates | Gestational age will be defined based on obstetric ultrasound, date of last menstrual period, or clinical exam at delivery (Capurro method). | Delivery to 28 days after delivery |
| Birth weight at delivery of liveborn neonates | Weight in grams | Delivery to 28 days after delivery |
| Number of neonates with any neonatal complications | Neonatal complications are defined as neonatal death, low birth weight (<2,500 g), preterm delivery (<37 weeks), or small for gestational age. | Delivery to 28 days after delivery |
| Number of neonates admitted to the intensive care unit (ICU) | Number of neonates admitted to the intensive care unit (ICU) | Delivery to 28 days after delivery |
| Number of pregnant participants admitted to the hospital for any reason after delivery | Number of pregnant participants admitted to the hospital for any reason after delivery | Delivery to 28 days after delivery |
| Number of pregnant participants admitted to the hospital due to delivery complications | Delivery complications are defined as postpartum hemorrhage, sepsis, perineal tears, or thromboembolism. | Delivery to 28 days after delivery. |
| Number of pregnant participants with a prolonged hospital stay following delivery | A prolonged hospital stay is defined as more than 72 hours after delivery | Delivery to 28 days after delivery |
| Policlínica Hospital Municipal Duque de Caxias | Recruiting | Duque de Caxias | Rio de Janeiro | Brazil |
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| Unidade Básica de Saúde José de Freitas | Not yet recruiting | Duque de Caxias | Rio de Janeiro | Brazil |
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| Hospital Federal dos Servidores do Estado | Recruiting | Rio de Janeiro | Rio de Janeiro | Brazil |
| ID | Term |
|---|---|
| D013590 | Syphilis, Congenital |
| ID | Term |
|---|---|
| D013587 | Syphilis |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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