Routine STI screening during pregnancy to improve birth outcomes
Official title: Screening and Treatment for Chlamydia Trachomatis Infection to Prevent Preterm Birth
Run by University of California, San Diego · NCT07458802 · Data updated 2026-11-12
This study tests whether adding screening and treatment for chlamydia and gonorrhoea to standard antenatal care can reduce preterm birth and other problems for pregnant women in Botswana.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 15 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (Gaborone) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | January 1, 2030 |
| Study ends | July 1, 2030 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07458802 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women ≤20 weeks gestation, ≥15 years old, residing in Gaborone or nearby areas, attending their first ANC visit, and asymptomatic for cervicovaginitis at intake.
✕Probably not a fit
Pregnant women outside the geographic area, later in pregnancy, or with symptoms requiring immediate STI treatment may see no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls about 2,000 pregnant women at up to ten clinics in Botswana who are at their first antenatal visit. Participants are randomized to either standard antenatal care or standard care plus screening for chlamydia and gonorrhoea using self-collected vaginal swabs in early pregnancy and again in the third trimester. Those in the intervention group who test positive will receive treatment as part of the routine care. The study will evaluate birth outcomes and also consider cost-effectiveness for the health system. The trial uses routine HIV and syphilis testing as part of standard care and follows Botswana national guidelines.
Why it matters
Potential benefit: If successful, routine STI screening could reduce adverse birth outcomes and be cost-effective for health systems.
How similar studies have gone: Prior studies suggest STI screening in pregnancy can impact outcomes, but this specific routine, cost-effectiveness evaluation in Botswana is novel/limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Asymptomatic for cervicovaginitis at first ANC (i.e., not syndromically treated for an STI by clinic midwives at first ANC) 2. Age ≥ 15 years 3. Currently pregnant 4. ≤20 weeks gestation (based on gestational age in obstetric record or last menstrual period if gestational age missing from record) 5. Attending first ANC visit 6. Residence in Gaborone, Bostwana or surrounding villages through the time of delivery 7. Mentally competent to understand study procedures or give informed consent
Where it's running
-
Botswana Harvard Health Partnership
Gaborone, Botswana Recruiting
Study contacts
- Study coordinator: Adriane Wynn, PhD MPP
- Email: awynn@health.ucsd.edu
- Phone: +1 (916) 662-1497
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.