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Could routine STI screening during pregnancy prevent preterm births?

NCT ID NCT04446611

Prevention Sponsor: Foundation for Professional Development (Pty) Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study compares different ways of screening pregnant women for three common sexually transmitted infections (chlamydia, gonorrhea, and trichomonas) to see if treating these infections can reduce the risk of preterm birth and low birth weight. Over 2,200 pregnant women in South Africa are randomly assigned to one of three groups: screening at the first prenatal visit with a follow-up test to confirm cure, screening at the first visit plus a repeat test later in pregnancy, or standard care (treating symptoms only). The study also looks at cost-effectiveness and how the vaginal microbiome may affect treatment success.

What this could mean

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

Active substance
diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis
What this could lead to
If effective, this screening strategy could reduce preterm births and low birth weight in regions with high STI rates, improving newborn health and guiding public health policy.
What could go wrong
This is a pragmatic trial comparing screening strategies, not a new drug; results may vary by setting and may not show a clear benefit over standard care.

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

2,247 people

The number who actually took part.

Started

Mar 2021

Finished

Feb 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 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 (Amended to \<27 weeks, after 328 participants (14%) had been enrolled, to mitigate COVID-19 delays and align with similar studies) 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 ≥27 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

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Conditions

The condition(s) this trial relates to.

AIDS chlamydia trachomatis infectious disease gonorrhea sexually transmitted disease Trichomonas vaginitis urogenital infection

As listed by the trial registrant

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

Antenatal care Birth outcomes Chlamydia trachomatis Cost-effectiveness HIV/AIDS Neisseria gonorrhoeae Pregnancy Sexually transmitted infection Trichomonas vaginalis Vaginal microbiome

Contacts and locations

Locations

  • Buffalo City Metro

    East London, Eastern Cape, 5217, South Africa

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