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Could a simple STI test prevent preterm birth?

NCT ID NCT07458802

Prevention Sponsor: Adriane Wynn Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study will test whether screening pregnant women for chlamydia and gonorrhea can reduce the risk of preterm birth. About 2,000 women in Botswana will be randomly assigned to receive either standard care or additional STI testing early in pregnancy and again in the third trimester. The goal is to see if finding and treating these infections lowers the number of babies born before 37 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chlamydia and gonorrhea screening test
What this could lead to
If it works, this could lead to a simple, cost-effective way to prevent preterm birth and improve newborn health in high-risk regions.
What could go wrong
This is a screening study, not a treatment trial. It may not show a clear benefit, and results may not apply to other populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chlamydia infectious disease chlamydia trachomatis infectious disease gonorrhea Premature Birth sexually transmitted disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antenatal care Antenatal health Chlamydia Chlamydia trachomatis Chlamydia trachomatis infection Chlamydia trachomatis infection in pregnancy Preterm birth STI

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Botswana Harvard Health Partnership

    RECRUITING

    Gaborone, Botswana

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