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Study links vaginal germs to preterm birth risk

NCT ID NCT06131749

Knowledge-focused Sponsor: University of Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study followed 603 pregnant women in South Africa to see if infections or bacteria in the vagina are linked to how early they give birth. Researchers tested for sexually transmitted infections, yeast, and other germs at the start of pregnancy and again at 30-34 weeks. The goal was to understand which combinations of microorganisms might lead to earlier delivery. The study is complete and may help design future ways to prevent preterm birth.

What this could mean

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

What this could lead to
If successful, this research could help identify which infections or bacteria combinations increase the risk of early birth, leading to better screening and prevention strategies.
What could go wrong
This is an observational study, so it cannot prove cause and effect. 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.

Participants

603 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2024

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.

Who is studied

Pregnant women receiving antenatal care at one primary health care facility in Buffalo City Metropolitan Municipality, Eastern Cape Province, South Africa.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Living in Buffalo City Metropolitan Municipality * Intend to deliver in the same municipality * \<27 weeks of gestation at enrolment, confirmed by ultrasound * Provide written informed consent Exclusion Criteria: * Participation in any other research study * Inability to understand and speak a local language (English, Afrikaans, or isiXhosa).

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis chlamydia trachomatis infectious disease gonorrhea hepatitis HIV infectious disease infectious disease Mycoplasmoides infection Pregnancy Complications, Infectious Premature Birth sexually transmitted disease Trichomonas vaginitis urogenital infection trichomoniasis Ureaplasma urethritis vulvovaginal candidiasis

As listed by the trial registrant

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

Bacterial vaginosis Chlamydia trachomatis infection Genital mycoplasma infection HIV infections Microbial colonization Mycoplasma genitalium infection Neisseria gonorrheae infection Pregnancy; infection Premature birth Sexually transmitted infections (not HIV or hepatitis) Trichomonas vaginitis Ureaplasma urealyticum infection Vaginal candida

Contacts and locations

Locations

  • Empilweni Gompo Community Health Centre

    East London, Eastern Cape, 5209, South Africa

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