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NOT YET RECRUITING
NCT07458802
NA

Healthy Expectancy Through Routine Antenatal STI Screening

Sponsor: Adriane Wynn

View on ClinicalTrials.gov

Summary

This study will evaluate whether routine screening and treatment for two common sexually transmitted infections, chlamydia and gonorrhoea, during pregnancy can reduce preterm birth and other poor birth outcomes in Botswana, and whether this approach is affordable and cost-effective for the health system. About 2,000 pregnant women attending their first antenatal care visit at up to 10 government clinics in Botswana will be invited to join the study. All women will first receive the usual antenatal care services provided in Botswana, including routine health checks and HIV and syphilis testing. Women who enroll in the study will be randomly assigned to one of two groups: 1. Standard of care group: Women receive routine antenatal care only. 2. Intervention group: In addition to routine antenatal care, women are screened for chlamydia and gonorrhoea using self-collected vaginal swabs at their first antenatal care visit and again in the third trimester. The main outcome of the study is whether screening and treating chlamydia and gonorrhoeae reduces preterm birth (before 37 weeks). Other outcomes include low birth weight, very preterm birth, and maternal health conditions.

Official title: Screening and Treatment for Chlamydia Trachomatis Infection to Prevent Preterm Birth

Key Details

Gender

FEMALE

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-02

Completion Date

2030-07

Last Updated

2026-03-09

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Chlamydia trachomatis and Neisseria gonorrhoeae screening

Screening with Xpert® CT/NG assay at first antenatal care and third trimester

Locations (1)

Botswana Harvard Health Partnership

Gaborone, Botswana