Pregnancy Clinical Trial
Official title:
Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women. Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3). Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes
Status | Recruiting |
Enrollment | 2500 |
Est. completion date | April 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria for pregnant women: 1. Age=18 years 2. Currently pregnant based on positive urine pregnancy test 3. Attending first ANC visit for current pregnancy 4. Gestational age <20 weeks 5. Agreeing to nurse-collected specimens 6. Resident in Buffalo City Municipality (BCM) 7. Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM Gestational age will be confirmed via ultrasound Exclusion Criteria: 1. Planning to relocate during pregnancy or deliver in an MOU outside of BCM 2. Unknown HIV status (e.g. refusal, invalid test result) 3. Currently participating in another ANC/HIV study 4. When the ultrasound confirms =20 weeks gestation at first ANC Inclusion criteria for Neonates: 1) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs |
Country | Name | City | State |
---|---|---|---|
South Africa | Buffalo City Metro | East London | Eastern Cape |
Lead Sponsor | Collaborator |
---|---|
Foundation for Professional Development (Pty) Ltd | Louisiana State University Health Sciences Center in New Orleans, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), University of Alabama at Birmingham, University of Cape Town, University of Southern California |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of adverse birth outcomes among study arms | Adverse birth outcomes as defined by a composite measure of preterm birth (born alive before 370/7 weeks gestation) or low birth weight (less than 2500g) as recorded in the maternity case records | Recorded within 2 weeks of delivery | |
Secondary | Change in STI prevalence (a) between baseline visit and delivery within the experimental arms and (b) between the experimental and control arms by delivery. | To calculate the relative and absolute change in Chlamydia, Gonorrhea, and Trichomoniasis prevalence. Additionally, generalized estimating equations to test for variation in STI prevalence among study arms will be done, adjusting for potential effect modifiers and confounding variables | Between baseline (first antenatal visit <27 weeks' gestation) and delivery outcome (collected within 2 weeks post-delivery) | |
Secondary | Correlation between Bacterial vaginosis-associated vaginal community state types and clearance of Chlamydia infection | To determine the correlation between Bacterial vaginosis-associated vaginal community state types and chlamydial infection clearance as measured by a positive or negative chlamydial test result no less than three weeks after treatment and thence weekly until a negative Chlamydia test result is recorded. | Assessed through study completion | |
Secondary | Incidence of Preterm birth among study arms | The frequency of live births before 37 weeks' gestation, as validated by ultrasound dating at first antenatal visit | At delivery | |
Secondary | Incidence of Low birthweight infants among study arms | The frequency of live births with birth weight < 2500g, as recorded in the maternity case records | Within 2 weeks post-delivery | |
Secondary | Incidence of STI in infants exposed to infection in their mothers | Frequency of Chlamydia, Gonorrhoeae, and/or Trichomonas infection among infants born to a mother in whom infection is detected post-delivery | STI testing in mother and infants within 2 weeks post-delivery to a maximum of 6 weeks post-delivery | |
Secondary | Frequency of fetal loss (miscarriage or stillbirth) among study arms | Composite frequency of miscarriage (<28 weeks' gestation) or stillbirth (> 28 weeks' gestation) and the individual components, as indicated in the maternal case records | Assessed through study completion |
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