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New hope for preterm labor: simple vaginal tablet may buy extra time for babies

NCT ID NCT07344064

Disease control Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether adding a vaginal tablet containing good bacteria and a low-dose hormone (Gynoflor®) to standard preterm labor treatment can help women stay pregnant longer. About 80 pregnant women between 24 and 33 weeks will receive either the tablet or a placebo for 6 days. The main goal is to see if more women remain pregnant beyond 7 days after starting treatment.

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 80 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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

18 to 35 years

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 \- Pregnant women diagnosed with preterm labor or threatened preterm labor, with a gestational age between 24 and 33 weeks, who are receiving tocolytic therapy. Exclusion Criteria * Age under 18 years or 35 years and older * Incomplete course of Gynoflor® (less than 6 days of use) * Presence of contraindications to tocolysis * Preterm premature rupture of membranes (PPROM) * Unable to be contacted for follow-up * History of allergy to probiotics or Gynoflor® * Multiple gestation * History of short cervix diagnosed between 16-24 weeks of gestation * History of previous preterm labor (PTL) * Pregnancy achieved via assisted reproductive technology (ART) * Presence of fetal anomaly * History of antepartum hemorrhage * Substance abuse, including cigarette smoking, alcohol, cocaine, or heroin use * Other causes of preterm labor such as uterine overdistension (e.g., polyhydramnios, multifetal gestation), uterine abnormalities (e.g., myoma uteri), or systemic infections, except vaginitis

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis

As listed by the trial registrant

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

Bacterial vaginitis Prethrem labour Threaten preterm

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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