Healthy Expectancy Through Routine Antenatal STI Screening

Sponsor
Adriane Wynn
Study ID
NCT07458802
Status
Recruiting
Apply to this trial

Conditions

  • Antenatal Care
  • Antenatal Health
  • Chlamydia
  • Chlamydia Trachomatis
  • Chlamydia Trachomatis Infection
  • Chlamydia Trachomatis Infection in Pregnancy
  • Preterm Birth
  • STI

Eligibility Criteria

Sex
FEMALE
Age
15 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Chlamydia trachomatis and Neisseria gonorrhoeae screening — DIAGNOSTIC_TEST
    Screening with Xpert® CT/NG assay at first antenatal care and third trimester

Study Details

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.

Key Dates

First listed
Mar 9, 2026
Start date
May 25, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Standard of Care
    Participants in the standard-of-care arm will receive syndromic STI assessment per Botswana national guidelines.
  • Experimental: Intervention
    Participants randomized to the Intervention arm will receive the standard of care with additional Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) screening and treatment, at two time points: 1) first antenatal care visit and 2) third trimester between 28-32 weeks gestation (n=1,000). If participants are positive for CT and/or NG they will receive counseling and treatment according to US CDC guidelines, counseling and information about partner notification and treatment with several options available for partner treatment, and a test of cure after four weeks.

Primary Outcome Measure

Preterm birth [ Time Frame: Weeks gestation at birth, calculated from delivery date and date of last menstrual period and first trimester ultrasound dating ]

Central Contacts

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