Congenital syphilis
Conditions
Interventions
This is a randomized clinical trial, parallel, two arms, open, with 166 participants randomly allocated (1:1) into two groups of 83 pregnant women each, by simple randomization generated electronicall
randomization, laboratory tests and outcome analyses will be performed by blinded investigators, however masking will not be possible for participants and health professionals due to the nature of the
the intervention group will receive standardized short messages sent weekly on a fixed day previously defined (initially on Thursdays), with the purpose of reinforcing therapeutic follow up and identi
the basic content of the message will be: “Hello, this is the prenatal care support team linked to your health unit. We remind you that your next dose of benzathine penicillin is scheduled for the day
2 – I have a problem”
participants will be able to reply through the same channel within 24 hours, the responses will be monitored by the local health team who will take the necessary actions, with referral to the responsi
a researcher will record and categorize the responses, and participants who answer “I have a problem” or do not answer will be contacted by the non respondent tracking team for additional support
the entire intervention will take place virtually through messaging application and short message system, without replacing the routine prenatal care
the control group will be followed according to the usual routine of health services without receiving additional messages
Sponsors
Centro Universitário Norte do Espírito Santo – Universidade Federal do Espírito Santo (UFES)
Centro Universitário Norte do Espírito Santo – Universidade Federal do Espírito Santo (UFES)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women diagnosed with syphilis infection during pregnancy; before starting treatment or shortly after the first dose of benzathine penicillin; age 18 years or older; reside in the study area; have access to a mobile phone capable of receiving and sending text messages; willing to be followed up for up to six weeks after delivery
Exclusion criteria
Exclusion criteria: Pregnant women who have already completed syphilis treatment in the current pregnancy; pregnant women unable to communicate via text messaging; pregnant women who do not agree to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the complete and adequate treatment of syphilis during pregnancy according to the medication number of doses and prescribed intervals in accordance with current protocols assessed by a trained professional based on records available in the Health Information System for Primary Care e-SUS Surveillance in Health in the Citizen’s Electronic Health Record of e-SUS Primary Health Care in the pregnant woman’s prenatal card and in the birth information extracted from the child’s health booklet | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the analysis of the completeness of syphilis treatment during pregnancy defined as the full record of the therapeutic steps of the pregnant woman including number of doses administered appropriate intervals correct prescription of benzathine penicillin and records in the information systems Health Information System for Primary Care e-SUS Surveillance in Health Citizen’s Electronic Health Record of e-SUS Primary Health Care and the pregnant woman’s prenatal card in accordance with current protocols | — |
Countries
Brazil
Contacts
Public ContactKeila Mascarello
Universidade Federal do Espírito Santo
Outcome results
None listed